Clinical trial NCT01421186
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma MOR03087 (MOR202) Lenalidomide Pomalidomide CD38
Sponsor: MorphoSys AG
Start date: 2011-07-01; Completion date: 2020-08-01
Enrollment: 91 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.

Detailed description:
The study enrolled patients aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment regimens with MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3 + 3 design. Dose-escalation and expansion was done either with MOR202 intravenous infusions alone (MOR202 q2w \[twice a week\] and q1w \[weekly\] groups) or in combination with dexamethasone (MOR202 with dexamethasone group), with dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide group). Primary endpoints were safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity.

Arms: arm 1: Part A: MOR03087 dose escalation; biweekly treatment

Part B: MOR03087 dose escalation; weekly treatment

Part C: MOR03087 dose escalation (weekly treatment) + dexamethasone

Part D: MOR03087 weekly treatment in combination with pomalidomide + dexamethasone

Part E: MOR03087 weekly treatment in combination with lenalidomide + dexamethasone

For all parts, patients will be treated until disease progression (PD) or until a maximum of 3 years after first treatment. arm 2: Confirmatory cohorts of MOR03087 monotherapy (plus or minus dexamethasone), in combination with pomalidomide plus dexamethasone, and in combination with lenalidomide plus dexamethasone.

Following completion of Parts A, B, and C (dose escalation of MOR03087 biweekly and weekly schedules), the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen will be confirmed in a minimum of 6 subjects.

Following completion of Parts D (dose escalation of MOR03087 in combination with pomalidomide + dexamethasone) and E (dose escalation of MOR03087 in combination with lenalidomide + dexamethasone), the MTD and/or recommended dose in each part will be confirmed in a minimum of 6 subjects.

For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.
Interventions: intervention 1: MOR03087 phase 1 dose escalation intervention 2: MOR03087 intervention 3: Dexamethasone intervention 4: Pomalidomide intervention 5: Lenalidomide
Intervention descriptions: intervention 1: Treatment cycles will be 28 days. Initial MOR03087 doses will be 0.01 mg/kg in part A, 4 mg/kg in parts B and C and 8 mg/kg in parts D and E; in all parts MOR03087 doses will be escalated to a maximum of 16 mg/kg. In part A, patients will receive a biweekly intravenous infusion of MOR03087 which will be administered on days 1 and 15 of the cycle. In parts B to E patients will receive a weekly intravenous infusion of MOR03087 which will be administered on days 1, 8, 15, and 22 of the cycle.

In all parts a loading dose of MOR03087 will be additionally administered on day 4 of cycle 1. intervention 2: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E. intervention 3: Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (\> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4. intervention 4: Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle. intervention 5: Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.

Protocol documents:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL 
AMENDMENT 11
A Phase I/IIa, Open-Label, Multicentre, Dose-Escalation Study to Evaluate 
the Safety and Preliminary Efficacy of the Human Anti-CD38 
Antibody MOR03087 as Monotherapy and in Combination with 
Standard Therapy in Subjects with Relapsed or Refractory Multiple
Myeloma
Brief Description of Study
Open-label, 
multicentre, 
dose-escalation 
study 
to 
characterize the safety and preliminary efficacy of the human 
anti-CD38 antibody MOR03087 in adult subjects with 
relapsed/refractory multiple myeloma as monotherapy and in 
combination with standard therapy
Study Type:
Phase I/IIa
Sponsor:
MorphoSys AG
Sponsor's Address:
Semmelweisstr. 7 
D-82152 Planegg 
GERMANY
Study Protocol Number:
MOR202C101
EudraCT No.:
2009-015942-50
Original Protocol
Final v1.0, 25 Oct 2010
Protocol Amendment 1
Final v2.0, 21 Mar 2011
Protocol Amendment 2
Final v3.0, 23 Jul 2012
Protocol Amendment 3
Final v4.0, 11 Jan 2013
Protocol Amendment 4
Final v5.0, 27 Sep 2013
Protocol Amendment 5
Final v6.0, 29 Nov 2013
Protocol Amendment 6
Final v7.0, 15 Apr 2014
Protocol Amendment 7
Final v8.0, 30 Jul 2014
Protocol Amendment 8
Final v9.0, 05 Nov 2014
Protocol Amendment 9
Final v10.0, 25 Jun 2015
Protocol Amendment 10
Final v11.0, 20 Feb 2017
Protocol Amendment 11
Final v12.0, 17 Jul 2017
Confidentiality Statement
This confidential document is the property of MorphoSys AG. No unpublished information in 
this document may be disclosed without prior written approval of MorphoSys AG.


Product Name: MOR03087 
Date: 17 Jut 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101 
EudraCT N umber: 2009-015942-50
SIGNATURES
Protocol Prepared and Approved/Authorized By:
Signature:
Signature:
Signature:
Signature:
Signature:
Sponsor: MorphoSys AG
Confidential
Page 2 o f]43


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Coordinating Investigator’s Signature
I have read the entire clinical study protocol. I agree that this protocol version contains all 
the information required to conduct this study.
Investigator:
Signature:
Printed Name:
Address:
Date:
Sponsor: MorphoSys AG
Confidential
Page 3 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Signature of Principal Investigator, Co-Investigator, or 
Sub-Investigator
I have read the entire clinical study protocol. I agree that this protocol version contains all 
the information required to conduct this study. I agree to conduct the study as outlined in the 
study protocol and to comply with all the terms and conditions set out therein. I confirm that 
I will conduct the study in accordance with ICH GCP guidelines and the provisions of the 
current Helsinki Declaration, copies of both documents have been given to me by the 
sponsor, I will also ensure that co-investigator(s) and other relevant members of my staff 
have access to copies of this protocol, the ICH GCP guidelines and the Helsinki Declaration 
to enable them to work in accordance with the provisions of these documents.
Signature: 
Date:
Printed Name:
Address:
Sponsor: MorphoSys AG
Confidential
Page 4 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Contact Details of Key Study Personnel
Sponsor’s Medical Expert
Sponsor Clinical Project 
Manager
Contact for Serious Adverse 
Events (SAEs):
Medical Monitor 
(24/7 Medical Coverage)
24/7 Medical Coverage
CRO Project Manager
Sponsor: MorphoSys AG
Confidential
Page 5 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
1 
SYNOPSIS
Title of Study
A Phase I/IIa, Open-Label, Multicentre, Dose-Escalation Study to 
Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD38 
Antibody MOR03087 as Monotherapy and in Combination with Standard 
Therapy in Subjects with Relapsed or Refractory Multiple Myeloma
Investigational Medicinal 
Drug
MOR03087, a fully human monoclonal antibody targeting the CD38 
membrane protein
Protocol Number
MOR202C101
EudraCT Number
2009-015942-50
Sponsor and CRO
Sponsor:
MorphoSys AG 
Semmelweisstr. 7 
D-82152 Planegg 
GERMANY
Clinical Research Organization (CRO):
Study Phase
Phase I/IIa
Background
Despite the approval of the novel therapeutic agents lenalidomide (LEN) 
and pomalidomide (POM) for relapsed disease, multiple myeloma (MM) 
remains an incurable malignancy. One of the most strongly and uniformly 
expressed antigens on malignant plasma cells is CD38, which is found in 
all multiple myelomas. Because of this expression pattern, an anti-CD38 
antibody may have clinical utility as a new therapeutic approach to MM 
treatment. MOR03087 is a fully human monoclonal antibody directed to 
CD38 that has demonstrated in vitro and in vivo efficacy in preclinical 
MM models.
Relapsed and refractory myeloma, associated with median survival rates 
of less than 30 months in most studies and progressively lower response 
rates to therapy, remains an unmet medical need. Further improvements 
in overall response, duration of clinical benefit, progression-free survival 
(PFS), and overall survival (OS) are desirable, and even minimal 
responses to therapy may be associated with symptomatic benefit. Novel 
synergistic combinations of anti-myeloma drugs with different modes of 
action may be warranted to overcome drug resistance and improve patient 
outcome. In preclinical studies, the combination of an immunomodulatory 
derivative (“IMiD”, LEN) with MOR03087 demonstrated increased 
cytotoxicity compared with either agent alone in MM cell lines, 
supporting the combination of these therapies clinically.
Study Purpose/Rationale The purpose of this study is to characterize the safety profile and 
preliminary efficacy of MOR03087 and establish the maximum tolerated 
dose (MTD) or recommended dose of MOR03087 as monotherapy with 
or without dexamethasone (DEX) as well as in combination with two 
standard IMiD therapies (POM+DEX and LEN+DEX) in adult subjects 
with relapsed or refractory MM.
Sponsor: MorphoSys AG
Confidential
Page 6 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Study Objectives (Key 
Primary and Secondary)
PRIMARY OBJECTIVES:
1. To assess the safety profile and to establish the MTD and/or 
recommended dose of MOR03087 in subjects with relapsed or 
refractory MM:
a. As monotherapy
b. In combination with DEX
c. In combination with POM + DEX
d. In combination with LEN + DEX
2. To assess the immunogenicity of MOR03087
SECONDARY OBJECTIVES:
1. To evaluate the pharmacokinetics and pharmacodynamics of 
MOR03087 in subjects with relapsed or refractory MM:
a. As monotherapy
b. In combination with DEX
c. In combination with POM + DEX
d. In combination with LEN + DEX
2. To evaluate the preliminary efficacy of MOR03087 in subjects with 
relapsed or refractory MM:
a. As monotherapy
b. In combination with DEX
c. In combination with POM + DEX
d. In combination with LEN + DEX
Study Endpoints (Key 
Primary and Secondary)
PRIMARY ENDPOINTS:
1. Determination of the MTD and/or recommended dose of MOR03087 
as monotherapy, in combination with DEX, and in combination with 
POM+DEX and LEN+DEX
2. Determination of the recommended dosing regimen of MOR03087
3. Incidence and severity of adverse events (AEs)
4. Immunogenicity of MOR03087 based on both absolute (number and 
percentage of subjects who develop anti-MOR03087 antibodies) and 
semi-quantitative (anti-MOR03087 antibody titer determination of 
confirmed positive samples) assessments
SECONDARY ENDPOINTS:
1. Pharmacokinetics of MOR03087 +/- LEN or POM
2. Absolute and percent change from baseline in measurements of B, T, 
and natural killer (NK) cell populations
3. Overall response rate (stringent complete response [sCR], complete 
response [CR] + very good partial response [VGPR], partial response 
[PR]), further tumor response rates (CR, sCR, PR, MR, VGPR), and 
stable disease (SD) rate
4. Duration of response, time to progression (TTP), and PFS
5. Absolute and percent change from baseline in serum and urine 
M-protein levels
6. Absolute and percent change from baseline in serum free light chain 
(FLC) levels and serum FLC ratio
7. Absolute changes from baseline in laboratory parameters (serum 
chemistry, hematology, urinalysis) and clinically relevant abnormal 
values
Sponsor: MorphoSys AG
Confidential
Page 7 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
8. Absolute change from baseline in overall quality of life scores
9. Change in cytokines from baseline
Design and Methodology
This is an open-label, multicentre, standard 3+3 dose-escalation study 
designed to characterize the safety profile and preliminary efficacy of 
MOR03087 in adult subjects with relapsed or refractory MM as 
monotherapy and in combination with DEX or standard IMiD therapy.
A 3+3 dose escalation design will be utilized to establish the MTD and/or 
recommended dose and dosing regimen of MOR03087 as monotherapy, 
weekly or bi-weekly, with or without DEX, and the MTD and/or 
recommended dose in combination with POM+DEX and LEN+DEX 
standard regimens. The MTD and/or recommended dose and dosing 
regimens will be confirmed in two confirmation cohorts of at least 6 
evaluable subjects each.
The MOR03087 dose levels proposed for this study range from 
0.01 mg/kg to 16.0 mg/kg administered by intravenous (IV) infusion.
Population
Adult subjects with relapsed or refractory MM (after at least two prior 
regimens).
Key Inclusion / 
Exclusion Criteria
INCLUSION CRITERIA FOR ALL SUBJECTS:
1. Male or female subjects > 18 years of age
2. Presence of serum M-protein > 0.5 g per 100 mL (> 5 g/L) and/or 
urine M-protein > 200 mg per 24-hour period
3. Life expectancy of > 3 months
4. Karnofsky performance status > 60%
5. Absolute neutrophil count (ANC) > 1.0 (1,000/mm3)
6. Total bilirubin < 2 x ULN
7. Alanine transaminase (ALT) and aspartate aminotransferase (AST) 
< 2.5 x ULN
8. Hemoglobin > 8 g/dL
9. If a female of childbearing potential, confirmation of a negative 
pregnancy test before enrolment and use of double-barrier 
contraception, oral contraceptive plus barrier contraceptive, for at 
least 28 days prior to, during therapy and for 28 days after the last 
dose, or confirmation of having undergone clinically documented total 
hysterectomy and/or bilateral oophorectomy, tubal ligation
10. If a male, he must practice complete abstinence or agree to use a 
condom during sexual contact with a pregnant female or a female of 
childbearing potential while participating in the study, during dose 
interruptions and for at least 28 days following study drug 
discontinuation, even if he has undergone a successful vasectomy
11. Ability to comply with all study-related procedures, medication use, 
and evaluations
12. Ability to understand and give written informed consent, and comply 
with the protocol
EXCLUSION CRITERIA FOR ALL SUBJECTS:
1. Primary refractory MM
2. Previous treatment with cytotoxic chemotherapy or large-field 
radiotherapy or other myeloma-specific therapy within 28 days prior 
to first study treatment (radiation to a single site as concurrent therapy 
is allowed)
Sponsor: MorphoSys AG
Confidential
Page 8 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
3. Treatment with a systemic investigational agent within 28 days prior 
to first study treatment.
4. Solitary plasmacytoma or plasma cell leukemia
5. Previous allogenic stem cell transplantation
6. Known or suspected hypersensitivity to the excipients contained in 
the study drug formulation
7. Significant 
uncontrolled 
cardiovascular 
disease 
or 
cardiac 
insufficiency (New York Heart Association [NYHA] classes III-IV)
8. Prior therapy with other monoclonal antibodies targeting the CD38 
antigen or prior therapy with other IgG monoclonal antibodies within 
3 months prior to first study treatment, or IgM monoclonal antibodies 
within 1 month prior to first study treatment
9. Clinical or laboratory evidence of active hepatitis B (positive HBsAg 
with negative HBsAb) or hepatitis C (positive HCV antibody)
10. History of positive HIV test result (ELISA or Western blot)
11. History of significant cerebrovascular disease or sensory or motor 
neuropathy of toxicity grade 3 or higher (per National Cancer Institute 
[NCI] Common Terminology Criteria for Adverse Events [CTCAE], 
version 4.0)
12. Presence of diarrhea of grade 2 or higher (per NCI CTCAE, 
version 4.0)
13. Any active systemic infection
14. Any antibiotic therapy due to infections 2 weeks prior to first study 
drug administration
15. Current treatment with immunosuppressive agents other than 
prescribed corticosteroids (not more than 10 mg prednisone 
equivalent)
16. Major surgery < 4 weeks prior to first study drug administration or 
ongoing side effects of such surgery
17. Systemic diseases (cardiovascular, renal, hepatic, etc.) that would 
prevent study treatment
18. MM with central nervous system (CNS) involvement
19. Prior or concomitant malignancy (other than MM) except adequately 
treated basal cell or squamous cell carcinoma of the skin, carcinoma 
in situ of the cervix, prostate cancer not requiring treatment or other 
cancer for which the subject has been disease-free for at least 3 years. 
For the combination therapy with LEN or POM, this should be at least 
5 years
20. Pregnancy or breastfeeding in women and women of childbearing 
potential not using an acceptable method of birth control
21. History of non-compliance to medical regimens or subjects who are 
considered potentially unreliable and/or not cooperative
ADDITIONAL ELGIBILITY CRITERIA FOR TREATMENT
WITH MOR03087 WITH/WITHOUT DEXAMETHASONE:
Inclusion Criteria
1. Documented diagnosis of MM; specifically, relapsed or refractory 
MM defined as:
• 
Failure of at least two previous therapies; previous therapies must 
include an immunomodulatory agent and a proteasome inhibitor
______ (either together or as part of different therapies)______________
Sponsor: MorphoSys AG
Confidential
Page 9 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
All subjects must have documented progression during or after 
their last prior therapy for MM
2. Creatinine 
clearance 
> 30 mL/min 
(calculated 
using 
the 
Cockcroft-Gault equation)
3. Platelets:
• 
> 80 x 109/L, without previous transfusion within the last 4 weeks 
before first study drug administration
• 
> 50 x 109/L (for dose levels > 4 mg/kg with or without DEX). 
Subjects are not allowed to have received platelet transfusion 
within the last 4 weeks before study drug administration.
Exclusion Criteria
1. For subjects receiving DEX: Known or suspected hypersensitivity to 
DEX or any of the excipients
ADDITIONAL ELIGIBILITY CRITERIA FOR THE 
TREATMENT WITH MOR03087, DEXAMETHASONE AND 
LENALIDOMIDE:
Inclusion Criteria
1. Documented diagnosis of MM; specifically, relapsed or refractory 
MM defined as:
• 
Received at least one previous therapy
• 
All subjects must have documented progression during or after 
their last prior therapy for MM
2. Ability to understand the reason for and understand the special 
conditions of the pregnancy prevention risk minimization plan and 
give written acknowledgement of these
3. Ability and willingness to comply with the special conditions of the 
pregnancy prevention risk minimization plan
4. Creatinine 
clearance 
> 50 mL/min 
(calculated 
using 
the 
Cockcroft-Gault equation)
5. Platelets:
• 
> 75 x 109/L for subjects in whom < 50% of bone marrow 
nucleated cells are plasma cells
• 
> 30 x 109/L for subjects in whom > 50% of bone marrow 
nucleated cells are plasma cells.
Exclusion Criteria
1. Known or suspected hypersensitivity or intolerance to LEN, POM, 
thalidomide, DEX or to any of the excipients
ADDITIONAL ELIGIBILITY CRITERIA FOR THE 
TREATMENT WITH MOR03087, DEXAMETHASONE AND 
POMALIDOMIDE:
Inclusion Criteria
1. Documented diagnosis of MM; specifically, relapsed and refractory 
MM defined as:
• 
Received at least two previous therapies including LEN and a
______ proteasome inhibitor___________________________________
Sponsor: MorphoSys AG
Confidential
Page 10 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
All subjects must have documented progression during or within 
60 days after their last prior therapy for MM
2. Ability to understand the reason for and understand the special 
conditions of the pregnancy prevention risk minimization plan and 
give written acknowledgement of these
3. Ability and willingness to comply with the special conditions of the 
pregnancy prevention risk minimization plan
4. Creatinine 
clearance 
> 45 mL/min 
(calculated 
using 
the 
Cockcroft-Gault equation)
5. Platelets
• 
>75 x 109/L for subjects in whom < 50% of bone marrow 
nucleated cells are plasma cells
• 
>30 x 109/L for subjects in whom > 50% of bone marrow 
nucleated cells are plasma cells.
Exclusion Criteria
1. Known or suspected hypersensitivity to POM, LEN, thalidomide, 
DEX or to any of the excipients
2. Subjects who are refractory (defined as progression during or within 
60 days after their last dose of POM) or intolerant to POM
Sample Size, Planned 
Total Number of Study 
Sites and Locations
Up to 126 subjects
• 
Up to 48 subjects for the MOR03087 monotherapy/bi-weekly 
escalation
• 
Up to 18 for the MOR03087 monotherapy/weekly escalation
• 
Up to 24 for the MOR03087 + DEX part (up to 18 for dose 
escalation cohorts and at least 6 for confirmatory cohort)
• 
Up to 18 for the MOR03087 + POM + DEX (up to 12 for dose 
escalation cohorts and at least 6 for confirmatory cohort)
• 
Up to 18 for the MOR03087 + LEN + DEX (up to 12 for dose 
escalation cohorts and at least 6 for confirmatory cohort)
Approximately 10-15 sites in Germany and Austria
Investigational Medicinal 
Drug(s) (Name, 
Description)
MOR03087, pomalidomide, lenalidomide, dexamethasone
Dose, Route of 
Administration, 
Treatment Regimen
In each cohort, 28-day cycles will be used.
An independent Data Monitoring Committee (DMC) will review the 
relevant safety information before considering dose escalation for the next 
cohort.
Part A: MOR03087 dose escalation (bi-weekly treatment):
- Dose level 1: 0.01 mg/kg
- Dose level 2: 0.04 mg/kg
- Dose level 3: 0.15 mg/kg
- Dose level 4: 0.5 mg/kg
- Dose level 5: 1.5 mg/kg
- Dose level 6: 4.0 mg/kg
- Dose level 7: 8.0 mg/kg
- Dose level 8: 16.0 mg/kg*
Sponsor: MorphoSys AG
Confidential
Page 11 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Each 28-day cycle will consist of a MOR03087 infusion on Day 1 and 
Day 15 of the cycle. In Cycle 1, a loading dose will additionally be 
administered on Day 4 of the cycle.
For Part A, at least 48 hours will pass between the first study drug 
administration to the subjects within a cohort in order to observe for AEs.
Part B: MOR03087 dose escalation (weekly treatment):
- Dose level 6b: 4.0 mg/kg*
- Dose level 7b: 8.0 mg/kg
- Dose level 8b: 16.0 mg/kg
Each 28-day cycle will consist of a MOR03087 infusion on Days 1, 8, 15, 
and 22 of the cycle. In Cycle 1, a loading dose will additionally be 
administered on Day 4 of the cycle.
Part C: MOR03087 dose escalation (weekly/biweekly treatment) plus 
low dose of dexamethasone:
- Dose level 6c: 4.0 mg/kg*
- Dose level 7c: 8.0 mg/kg
- Dose level 8c: 16.0 mg/kg
Each 28-day cycle will consist of:
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1 a 
loading dose will additionally be administered on Day 4 of the cycle. 
Only for dose level 8c, for cycles 4 and onwards each 28-day cycle will 
consist of:
MOR03087 infusion on Days 1 and 15 of the cycle.
Subjects who have received treatment beyond Cycle 3 will be switched to 
the biweekly schedule at the next Day 1 or Day 15 visit. In exceptional 
cases -  and after discussion between the investigator and the sponsor - 
the treating physician may determine that it is in the best interest of the 
subject to remain on the weekly MOR03087 schedule, in which case the 
sponsor should be informed accordingly.
Oral DEX 40 mg (< 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 
15, and 22 of the 28-day cycle, irrespective of whether MOR03087 is 
administered weekly or biweekly. In Cycle 1 on Day 4 (loading dose) oral 
DEX 40 mg (< 75 years old) or 20 mg (> 75 years old) will be added.
* Following the completion of Part B dose level 6b and Part C dose level 
6c, and taking into account available safety information from Part A dose 
level 8, the DMC will provide a recommendation if some or all of the 
planned weekly MOR03087 monotherapy dose escalation cohorts will be 
tested.
Following completion of Parts A, B, and C (dose escalation of 
MOR03087 bi-weekly and weekly schedules), the MTD or recommended 
dose and dosing regimen will be confirmed in a minimum of 6 subjects.
Sponsor: MorphoSys AG
Confidential
Page 12 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Part D: MOR03087 (weekly/biweekly treatment) in combination with 
POM+DEX
- Dose level 7d: 8.0 mg/kg
- Dose level 8d: 16.0 mg/kg
Each 28-day cycle will consist of:
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a 
loading dose will additionally be administered on Day 4 of the cycle.
Only for dose level 8d, for cycles 4 and onwards each 28-day cycle will 
consist of:
MOR03087 infusion on Days 1 and 15 of the cycle.
Subjects who have received treatment beyond Cycle 3 will be switched to 
the biweekly schedule at the next Day 1 or Day 15 visit. In exceptional 
cases -  and after discussion between the investigator and the sponsor - 
the treating physician may determine that it is in the best interest of the 
subject to remain on the weekly MOR03087 schedule, in which case the 
sponsor should be informed accordingly.
Oral POM 4 mg on Days 1-21 of the 28-day cycle.
Oral DEX 40 mg (< 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 
15, and 22 of the 28-day cycle, irrespective of whether MOR03087 is 
administered weekly or biweekly. In Cycle 1 on Day 4 (loading dose) oral 
DEX 40 mg (< 75 years old) or 20 mg (> 75 years old) will be added.
Part E: MOR03087 (weekly/biweekly treatment) in combination with 
LEN+DEX
- Dose level 7e: 8.0 mg/kg
- Dose level 8e: 16.0 mg/kg
Each 28-day cycle will consist of:
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a 
loading dose will additionally be administered on Day 4 of the cycle. 
Only for dose level 8e, for cycles 4 and onwards each 28-day cycle will 
consist of:
MOR03087 infusion on Days 1 and 15 of the cycle.
Subjects who have received treatment beyond Cycle 3 will be switched to 
the biweekly schedule at the next Day 1 or Day 15 visit. In exceptional 
cases -  and after discussion between the investigator and the sponsor - 
the treating physician may determine that it is in the best interest of the 
subject to remain on the weekly MOR03087 schedule, in which case the 
sponsor should be informed accordingly.
Oral LEN 25 mg on Days 1-21 of the 28-day cycle.
Oral DEX 40 mg (< 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 
15, and 22 of the 28-day cycle, irrespective of whether MOR03087 is 
administered weekly or biweekly. In Cycle 1 on Day 4 (loading dose) oral 
DEX 40 mg (< 75 years old) or 20 mg (> 75 years old) will be added.
Sponsor: MorphoSys AG
Confidential
Page 13 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Following completion of Parts D and E (dose escalation of MOR03087 in 
combination with POM-DEX and LEN-DEX), the MTD and/or 
recommended dose in each part will be confirmed in a minimum of 
6 subjects.
Part A dose levels 1-7 will be tested sequentially and only one dose level 
will be open for enrolment at any time. Starting with Part A dose level 8, 
Parts B and C will open in parallel (at dose level 6 [6b and 6c]). 
Following completion of dose level 7c (8.0 mg/kg MOR03087 + DEX) 
(and 7b if the DMC recommends to open this cohort), Cohorts 7d and 7e 
may open in parallel with dose levels 8b (if the DMC recommends to open 
this cohort) and 8c.
New cohorts will not start before the DMC returns a positive 
recommendation based on safety read-outs from prior cohorts as laid 
down in the DMC Charter.
All cohorts:
After the first administration of study drug, the subjects will remain at the 
site until the end of Day 2 for safety monitoring. The subjects will not stay 
overnight at the site for subsequent administrations.
Based on the individual risk/benefit ratio, subjects who have an ongoing 
response of at least SD may continue treatment with the assigned study 
regimen until disease progression.
In case subjects present with progressive disease or with no better status 
than SD after four treatment cycles starting with Cycle 1 Day 1, the 
investigator may add a standard weekly dose of dexamethasone to the 
regimen at his/her discretion, provided dexamethasone is not already part 
of the treatment regimen.
Modification or interruption of POM and LEN treatment
If upon treatment with POM or LEN, subjects present with toxicities,
treatment must be modified or interrupted accordingly.
Supply, Preparation and 
Administration
MOR03087 antibody is formulated in a histidine buffer ready for IV 
administration. MOR03087 will be presented in a labelled glass vial at a 
concentration of 8-12 mg/mL and an extractable volume of 5 mL 
(40-60 mg/vial). The appropriate number of vials will be supplied to each 
respective site. MOR03087 must be stored at -20°C. MOR03087 will be 
administered after dilution by slow IV infusion over approximately 
2 hours in 100 mL or 250 mL 0.9% sodium chloride solution. A stepwise 
shortening of the infusion duration is specifically laid out in the protocol. 
POM is supplied by the sponsor as 1 mg, 2 mg, 3 mg and 4 mg capsules 
for oral administration. The appropriate strength will be supplied to the 
subject. POM should be stored as directed on the label.
LEN is supplied by the sponsor as 5 mg, 10 mg, 15 mg, or 25 mg capsules 
for oral administration. The appropriate strength will be supplied to the 
subject. LEN should be stored as directed on the label.
DEX is a corticosteroid and will be used in the study as tablets containing 
4.0 mg or 8.0 mg DEX and excipients, supplied by the sponsor. Each 
subject will receive the respective number of tablets. The appropriate
Sponsor: MorphoSys AG
Confidential
Page 14 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
weekly dose of DEX must be administered as a single oral bolus. DEX 
should be stored as directed on the label.
Visit Schedule and 
Assessments
Refer to Schedules of Assessments in Section 7.1
Efficacy Assessments
Efficacy will be evaluated in terms of overall response rate (PR or better), 
further tumor response rates (sCR, CR, PR, VGPR, MR), SD rate, duration 
of response, TTP, and PFS, using the modified European Group for Blood 
and Marrow Transplantation (EBMT) criteria plus the International 
Myeloma Working Group Uniform Response Criteria. 
Pharmacodynamics will be assessed in terms of B, T, and NK cell 
populations; serum and urine M-protein levels; serum FLC levels (if 
applicable); and for subjects with CR, bone marrow histology.
Special Safety 
Assessments
Safety will be assessed in terms of physical examination, vital signs, 
electrocardiograms, hematological and biochemical tests, AEs, cytokines 
and immunogenicity.
Adverse Events will be graded according to NCI CTCAE, version 4.0, 
with a DLT being defined as an AE assessed as having a suspected or 
unknown relationship to the study drug (MOR03087, POM, or LEN) and 
meeting one of the following criteria:
• 
Non-hematologic DLT: 
o 
Liver
Any grade 3 AST/ALT that does not resolve to grade 1 within 
14 days or any grade 4 elevation in liver function tests 
(AST/ALT) 
o 
Gastrointestinal
> Grade 3 vomiting or nausea despite the use of standard
antiemetics
> Grade 3 diarrhea or constipation despite the use of optimal
treatment
o 
All other events
> Grade 3 (excluding hypersensitivity reactions and fatigue)
• 
Hematologic DLT:
o 
Grade 4 thrombocytopenia that requires more than one platelet 
transfusion and does not resolve to grade 2 or less within 
14 days
o 
Grade 4 neutropenia that does not resolve to grade 2 or less 
within 14 days
o 
or any other grade 4 hematologic toxicities that do not resolve 
to grade 2 or less within 14 days and that are considered 
clinically relevant by the investigator
• 
Any AE that delays treatment with study drug for more than 14 days
In addition, any event will only qualify as a DLT if a worsening of the 
event from baseline of at least 2 CTCAE Grades occurs.
The DLTs for the POM combination cohorts are specified as above except 
for the hematological DLTs which are as follows:
• 
Hematologic DLT:
o 
Grade 4 neutropenia for > 7 days
Sponsor: MorphoSys AG
Confidential
Page 15 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
o 
Febrile neutropenia (ANC <1000/mm3 with a single 
temperature of >38.3°C or a sustained temperature of > 38°C 
for more than 1 hour) 
o 
Thrombocytopenia
- Platelet count < 25,000/pL that requires more than one platelet 
transfusion or
- Platelet count > 25,000/pL to < 50,000/p.L with significant 
bleeding (defined as need for hospitalization and/or platelet 
transfusion)
- Or any other grade 4 hematologic toxicities that do not resolve 
to grade 2 or less within 14 days and that are considered 
clinically relevant by the investigator
The DLTs for the LEN combination cohorts are specified as above except 
for the hematological DLTs which are as follows:
• 
Hematologic DLT:
o 
Grade 4 neutropenia for > 7 days
o 
Febrile neutropenia (ANC <1000/mm3 with a single 
temperature of >38.3 °C or a sustained temperature of > 38°C 
for more than 1 hour) 
o 
Thrombocytopenia
- Platelet count < 30,000/pL that requires more than one platelet 
transfusion or
- Platelet count > 30,000/pL to < 50,000/p.L with significant 
bleeding (defined as need for hospitalization and/or platelet 
transfusion)
- Or any other grade 4 hematologic toxicities that do not resolve 
to grade 2 or less within 14 days and that are considered 
clinically relevant by the investigator
The DLT period covers Day 1 of cycle 1 (starting with first study drug 
administration) until Day 29 (before start of the second cycle).
Subjects experiencing DLTs should not receive further study drug.
A pharmacokinetic interim analysis may be performed at any time during 
dose escalation if unexpected MOR03087 serum concentration results are 
observed.
Subject-Reported 
Outcomes/Quality of Life
Quality of life will be evaluated using the QLQ-30 and the QLQ-MY20, 
an instrument for use in subjects with MM.
Pharmacokinetics
Concentration-time profiles 
and pharmacokinetic parameters of 
MOR03087 +/- LEN or POM will be assessed from samples collected on 
the following schedules (if not otherwise specified, a deviation of 
5 minutes from the planned collection time point will be acceptable):
Parts A, B, C:
MOR03087
• 
For the first MOR03087 administration, serum samples will be 
collected predose and then 1, 2, 4, 8, 14 ± 2 (optional), 22 ± 2, and 
28 ± 2 hours after start of first infusion.
• 
For all other MOR03087 administrations in Cycles 1 and 2, serum 
samples will be collected predose for trough level determination and
Sponsor: MorphoSys AG
Confidential
Page 16 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
then after completion of infusion (subjects in bi-weekly dosing will 
not have a dose on Day 50, so require only 1 serum sample that day).
• 
From Cycle 3 onwards, samples will be collected once per cycle 
(predose and after completion of infusion). This means sampling 
every cycle on D15.
• 
Follow-up: sample will be collected at follow-up visit 1 (or at EOS 
if no follow-up visit occurs)
Parts D, E:
MOR03087 combined with LEN or POM regimens dose escalation
• 
For the first MOR03087 administration, MOR03087 serum samples 
will be collected predose before administration of MOR03087 + 
LEN or POM and then 1, 2, 4, 8, 14 ± 2 (optional), 22 ± 2, and 
28 ± 2 hours after start of first infusion of MOR03087
• 
For all other MOR03087 administrations in Cycles 1 and 2, 
MOR03087 serum samples will be collected predose for trough 
level determination and after completion of infusion
• 
For the first MOR03087 administration, POM or LEN plasma 
samples will be collected predose before administration of 
MOR03087 + LEN or POM and then 1, 2, 8 and 22 ± 2 hours after 
start of first infusion of MOR03087
• 
For the 3rd, 6th and 8th MOR03087 administration in Cycles 1 and 2, 
POM or LEN plasma samples will be collected predose for trough 
level determination and after completion of infusion
• 
From Cycle 3 onwards, samples will be collected once per cycle 
(predose and after completion of infusion). This means sampling 
every cycle on D15.
• 
Follow-up: MOR03087 serum sample will be collected at follow-up 
visit 1 (or at EOS if no follow-up visit occurs)
Biomarker Assessments
CD38 expression on plasma cells in the bone marrow and peripheral 
blood; CD16 expression on NK cells and FcYRIIIa phenotype
Immunogenicity
Assessments
Absolute 
(number 
of subjects 
with 
anti-MOR03087 
antibody 
development) and semiquantitative (anti-MOR03087 antibody titer 
determination of confirmed positive samples) assessments of MOR03087 
immunogenicity
Other Biomarker Studies 
on Additional / 
Remaining Samples
Cytokine evaluation will be performed before (predose) and 2 hours after 
the end of the first dose administration. The serum chemistry panel at 
screening will include p2-microglobulrn.
A bone marrow sample will be collected at screening for potential DNA 
or RNA analysis at a later stage to allow for potential identification of 
biomarkers that could influence the pharmacokinetics and the 
pharmacodynamics of MOR03087.
Determinations of translocations t(4; 14) and t(14;16) and deletions Del13 
and Del17p13 as well as other cytogenetic aberrations with possible 
prognostic and/or predictive relevance in myeloma (e.g., 1q gain, t(11;14)) 
will be made at baseline or collected from historical data.
Provided sufficient quantities of serum are available, additional 
measurements of tetanus titer will be performed by central laboratories.
Sponsor: MorphoSys AG
Confidential
Page 17 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Data Monitoring 
Committee
An independent DMC will be constituted for dose escalation decisions 
prior to the enrolment of the first subject. The DMC will review the 
relevant safety information before considering dose escalation for the 
next cohort. The DMC membership, full scope of responsibilities, 
operating procedures, meeting frequency, data availability, reporting and 
record keeping requirements will be described in detail in the DMC 
charter.
Statistical Methods and 
Data Analysis
One of the primary endpoints will be to determine the MTD or 
recommended dose and dosing regimen for MOR03087 with or without 
DEX and in combination with two standard IMiD therapies (POM and 
LEN). This primary endpoint will be determined in the DLT evaluable 
population. The evaluable population will consist of all enrolled subjects 
who have received at least 1 cycle of MOR03087 (at least four doses for 
q1w or two doses for the q2w dosing schedule) (monotherapy or 
combination therapy) and if applicable per cohort, at least 16 doses of LEN 
or POM without dose modifications and who have minimum safety 
evaluations, including the first cycle and AEs reported from Day 1 after 
the start of the first infusion until Day 1 of the second cycle (before start 
of infusion). Subjects who withdraw before having received the minimum 
number of infusions/doses and safety evaluations due to DLT will be 
included in the DLT evaluable population; subjects who discontinue study 
treatment or require a dose modification for LEN or POM for reasons 
unrelated to a DLT within the first cycle will be excluded from the DLT 
evaluable population.
Following completion of Parts A-C (dose escalation of MOR03087 alone, 
bi-weekly and weekly, and weekly with DEX), the MTD and/or 
recommended dose will be confirmed in a minimum of 6 subjects. 
Following completion of Parts D and E (dose escalation of MOR03087 in 
combination with POM+DEX and in combination with LEN+DEX), the 
MTD and/or recommended dose in each part will be confirmed in a 
minimum of 6 subjects.
The recommended doses for the confirmation cohorts will be determined 
after review of all available safety data from the corresponding 
dose-escalation portion of the study and based on the recommendation of 
the DMC. The recommended dose may be the MTD or a dose below the 
MTD.
The other primary and secondary endpoints will be analyzed descriptively 
using summary statistics for continuous data and frequency tables for 
categorical data. The 95% confidence intervals will be presented for rates 
or means in the recommended dose group of each treatment arm where 
appropriate. Kaplan-Meier estimates will be used where applicable.
Sponsor: MorphoSys AG
Confidential
Page 18 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
2 TABLE OF CONTENTS
2.1 Overall Table of Contents
1 
SYNOPSIS....................................................................................................................................... 6
2 
TABLE OF CONTENTS............................................................................................................. 19
2.1 
Overall Table of Contents.................................................................................................. 19
2.2 
List of Tables...................................................................................................................... 23
2.3 
List of Figures.....................................................................................................................23
3 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS...........................................24
4 
BACKGROUND...........................................................................................................................27
4.1 
Overview of MOR03087....................................................................................................27
4.2 
Rationale for Dose Selection ..............................................................................................28
5 
STUDY PURPOSE/RATIONALE..............................................................................................29
6 
OBJECTIVES............................................................................................................................... 30
6.1 
Primary Objectives ............................................................................................................30
6.2 
Secondary Objectives .........................................................................................................31
7 
STUDY DESIGN.......................................................................................................................... 31
7.1 
Overall Study Design and Investigational Plan...............................................................31
7.2 
Study Timeframe ................................................................................................................44
7.3 
Risks and Benefits to Subjects ...........................................................................................44
7.3.1 Pregnancy Prevention Risk Minimization Plans......................................................45
8 
POPULATION.............................................................................................................................46
8.1 
Inclusion Criteria For All Subjects ...................................................................................46
8.2 
Exclusion Criteria For All Subjects ..................................................................................47
8.2.1 
Additional Eligibility Criteria for Treatment With MOR03087 With/Without
Dexamethasone.......................................................................................................48
8.2.2 
Additional Eligibility Criteria for the Treatment With MOR03087,
Dexamethasone and Lenalidomide..........................................................................48
8.2.3 
Additional Eligibility Criteria for the Treatment With MOR03087,
Dexamethasone and Pomalidomide........................................................................49
8.3 
Definition of Woman of Childbearing Potential..............................................................50
8.4 
Procedures for Enrollment ................................................................................................50
8.5 
Dose Limiting Toxicities ....................................................................................................50
8.6 
Other Reasons for Treatment Postponement..................................................................52
8.7 
Withdrawal and Termination Criteria.............................................................................52
8.7.1 
Subj ect Withdrawal.................................................................................................52
8.7.2 
Study or Site Termination.......................................................................................53
9 
TREATMENT OF SUBJECTS ...................................................................................................53
9.1 
Investigational Medicinal Products ...................................................................................54
9.1.1 MOR03087............................................................................................................... 54
Sponsor: MorphoSys AG
Confidential
Page 19 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Laboratory Evaluations prior to each Administration of MOR03087.................................54
9.1.2 
Drugs Used in Combination with MOR03087........................................................56
9.1.3 
Premedication and Management of Infusion Reactions...........................................57
9.1.4 
Dose Reductions and Modifications for POM, LEN and DEX................................57
9.2 
Method of Numbering Subjects and Assigning Subjects to Treatment Groups...........61
9.3 
Blinding............................................................................................................................... 62
9.4 
Prior and Concomitant Therapy......................................................................................62
9.5 
Treatment Compliance......................................................................................................63
10 STUDY PROCEDURES..............................................................................................................63
10.1 Dose Escalation Parts A - E (Bi-Weekly or Weekly MOR03087 With or Without
DEX, Weekly with POM+DEX, Weekly with LEN+DEX) and Confirmation 
Cohorts ................................................................................................................................ 64
10.1.1 Screening (< 4 Weeks before Day 1)...................................................................... 64
10.1.2 Cycle 1: Day 1.........................................................................................................65
10.1.3 Cycle 1: Day 2 .........................................................................................................67
10.1.4 Cycle 1: Day 4 .........................................................................................................67
10.1.5 Cycle 1: Day 8 .........................................................................................................68
10.1.6 Cycle 1: Day 15 .......................................................................................................70
10.1.7 Cycle 1: Day 22 .......................................................................................................71
10.1.8 Day 29 Visit (C2D1)...............................................................................................72
10.1.9 Day 36 Visit (C2D8) ...............................................................................................73
10.1.10 Day 43 Visit (C2D15).............................................................................................74
10.1.11 Day 50 Visit (C2D22).............................................................................................76
10.1.12 Follow-Up Visits.....................................................................................................77
10.1.13 Treatment Cycles 3+ Visits.....................................................................................78
10.1.14 End of Study (EOS) Visit........................................................................................81
11 EFFICACY, PHARMACOKINETIC, SAFETY, AND OTHER VARIABLES....................82
11.1 Efficacy and Pharmacodynamic Assessments.................................................................82
11.1.1 Efficacy Assessment................................................................................................82
11.1.2 Immune Cells..........................................................................................................83
11.1.3 Bone Marrow...........................................................................................................83
11.2 Pharmacokinetic Assessments...........................................................................................83
11.3 Safety Assessments.............................................................................................................84
11.3.1 Adverse Events........................................................................................................85
11.3.2 Physical Examination..............................................................................................86
11.3.3 Vital Signs...............................................................................................................87
11.3.4 Laboratory Evaluations...........................................................................................87
11.3.5 Electrocardiogram...................................................................................................91
11.4 Other Variables..................................................................................................................91
11.4.1 Demographic Data...................................................................................................91
11.4.2 Relevant Medical History and Current Medical Conditions...................................91
Sponsor: MorphoSys AG
Confidential
Page 20 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
11.4.3 Prior and Concomitant Medication and Examinations............................................91
11.4.4 Bone Marrow Aspiration/Biopsy............................................................................92
11.4.5 Pharmacogenetics and Genotyping.........................................................................92
11.4.6 Subject-reported Outcomes.....................................................................................92
12 SAFETY MONITORING............................................................................................................ 93
12.1 Adverse Event and Serious Adverse Event Recording and Reporting.........................93
12.2 Pregnancies.........................................................................................................................95
12.3 Venous Thrombotic Event Monitoring............................................................................96
12.4 Independent Data Monitoring Committee.......................................................................96
13 PROTOCOL AMENDMENTS AND OTHER CHANGES IN STUDY CONDUCT............97
13.1 Protocol Amendments........................................................................................................97
13.2 Other Changes in Study Conduct.....................................................................................97
14 DATA HANDLING AND ARCHIVING...................................................................................97
14.1 Completing and Signing Case Report Forms..................................................................97
14.2 Clinical Data Management ................................................................................................97
14.3 Archiving and Filing..........................................................................................................97
15 STATISTICAL METHODS AND PLANNED ANALYSIS .....................................................97
15.1 General Statistical Considerations...................................................................................97
15.2 Subject Characteristics......................................................................................................99
15.3 ImmunogenicityAnalysis ...................................................................................................99
15.4 Efficacy Analysis.............................................................................................................. 100
15.5 Pharmacodynamic and Biomarker Analysis.................................................................100
15.6 Pharmacokinetic Analysis ............................................................................................... 101
15.7 Safety Analysis .................................................................................................................. 101
15.7.1 Dose Limiting Toxicities and Maximum Tolerated Dose.....................................101
15.7.2 Adverse Events...................................................................................................... 102
15.7.3 Clinical Laboratory Evaluations............................................................................ 102
15.7.4 Vital Signs............................................................................................................. 103
15.7.5 Electrocardiograms................................................................................................ 103
15.7.6 Physical Examination............................................................................................ 104
15.8 Other Variables................................................................................................................ 104
15.8.1 Pharmacogenetics and Genotyping....................................................................... 104
15.8.2 Analysis of Quality of Life.................................................................................... 104
15.9 Sample Size Determination............................................................................................. 104
15.10 Significance Level............................................................................................................. 104
15.11 Procedures for Missing, Unused, and Spurious Data.................................................. 104
15.12 Rules for Excluding Subjects from Analysis................................................................. 105
15.13 Procedures for Reporting Deviations from Original Statistical Plan......................... 105
16 SPECIAL REQUIREMENTS AND PROCEDURES.............................................................105
16.1 Institutional Review......................................................................................................... 105
16.2 Ethical Considerations..................................................................................................... 105
Sponsor: MorphoSys AG
Confidential
Page 21 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
16.2.1 Regulatory and Ethical Compliance...................................................................... 105
16.2.2 Responsibilities of the Investigator and IRB/IEC................................................106
16.3 Investigator’s Responsibilities......................................................................................... 106
16.3.1 Overall Responsibilities........................................................................................ 106
16.3.2 Subject Informed Consent..................................................................................... 107
16.3.3 Direct Access to Source Data/Documents............................................................107
16.3.4 Confidentiality Regarding Study Subjects............................................................108
16.3.5 Relevant Protocol Deviations................................................................................ 108
16.4 Study Monitoring............................................................................................................. 109
16.5 Audit and Inspection........................................................................................................ 109
16.6 Insurance........................................................................................................................... 109
16.7 Study Report and Publication Policy..............................................................................109
17 REFERENCES........................................................................................................................... 111
18 APPENDICES............................................................................................................................. 113
18.1 Information on Investigational and Registered Products............................................113
18.2 Normal Limits for Vital Signs, Weight, Height, and ECG Intervals..........................114
18.3 Response Criteria for Multiple Myeloma ...................................................................... 115
18.4 New York Heart Association Functional Classification............................................... 117
18.5 Karnofsky Performance Status ....................................................................................... 118
18.6 International Staging System (ISS) Criteria and Durie-Salmon Staging Criteria....119
18.7 Equivalent Doses for Corticosteroids.............................................................................120
18.8 Pregnancy Prevention Risk Minimization Plans...........................................................121
18.8.1 Lenalidomide Pregnancy Prevention Risk Minimization Plan..............................121
18.8.2 Pomalidomide (CC-4047) Pregnancy Prevention Risk Minimization Plan..........131
18.9 Venous Thrombotic Event Algorithms........................................................................... 141
Sponsor: MorphoSys AG
Confidential
Page 22 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
2.2 List of Tables
Table 1 
Flow Chart and Schedule of Assessments: Part A (Bi-weekly Administration)...........37
Table 2 
Flow Chart and Schedule of Assessments: Parts B-E (Weekly Administration).........40
Table 3 
Titration scheme for shortening of infusion duration....................................................55
Table 4 
Lenalidomide Dose Reduction Steps by Dose Level....................................................58
Table 5 
LEN Dose Modification Instructions for Toxicities......................................................58
Table 6 
Pomalidomide Dose Reduction Steps by Dose Level...................................................59
Table 7 
Pomalidomide Dose Modification Instructions for Toxicities......................................60
Table 8 
DEX Dose Reduction Steps (Less Than or Equal to 75 Years Old).............................60
Table 9 
DEX Dose Reduction Steps (More Than 75 years Old)................................................60
Table 10 
Dose Reductions for Dexamethasone Related Toxicities..............................................61
Table 11 
Laboratory Evaluations.................................................................................................88
Table 12 
Criteria for Normal Limits for Vital Signs, and Weight.............................................. 114
Table 13 
Criteria for Normal Limits for ECGs.......................................................................... 114
Table 14 
Response Criteria for Multiple Myeloma.................................................................... 115
Table 15 
Criteria for NYHA Functional Classification.............................................................. 117
Table 16 
Criteria for Karnofsky Performance Status................................................................. 118
Table 17 
Criteria for International Staging System (ISS)........................................................... 119
Table 18 
Criteria for Durie-Salmon Staging.............................................................................. 119
Table 19 
Equivalent Doses for Corticosteroids.......................................................................... 120
Table 20 
Wells1 DVT Pre-Test Probability (PTP) Score...........................................................141
Table 21 
Wells1 PE Pre-Test Probability (PTP) Score...............................................................142
2.3 List of Figures
Figure 1: 
Overall Study Design, Dose Levels 6, 7, 8, and Confirmation Cohorts........................32
Figure 2: 
Overall Study Design, Individual Subject Treatment....................................................32
Figure 3 
Flow-chart for the down-titration of infusion duration..................................................56
Figure 4: 
Deep Vein Thrombosis Diagnostic Algorithm............................................................ 142
Figure 5: 
Pulmonary Embolism Diagnostic Algorithm.............................................................. 143
Sponsor: MorphoSys AG
Confidential
Page 23 of 143


3 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
ADCC 
Antibody-dependent cellular cytotoxicity
Product Name: MOR03087 
Protocol Number: MOR202C101
Date: 17 Jul 2017 
EudraCT Number: 2009-015942-50
Protocol Amendment 11, Final 12.0
ADCP
ADR
AE
AGES
ALT
ANC
aPTT
AST
AUC
AUCc -t
AUCq - »
BASG
bpm
CD38
CL
Cm a x
CNS
CR
CRO
CTCAE
DEX
DLT
DNA
DMC
EBMT
ECG
EDC
EDTA
ELISA
EMA
EOS
EORTC
eCRF
FLC
FSH
FCBP
GCP
GCSF
GGT
HBsAb
HBsAg
HCV
HIV
HR
IB
ICH
ICMJE
Antibody-dependent cellular phagocytosis 
Adverse drug reaction 
Adverse event
Agentur fur Gesundheit und Ernahrungssicherheit
Alanine transaminase
Absolute neutrophil count
Activated partial thromboplastin time
Aspartate aminotransferase
Area under the serum concentration vs. time curve
Area under the serum concentration vs. time curve from time 0 to the time t of 
the last quantifiable concentration
Area under the serum concentration vs. time curve from time 0 to infinity 
(extrapolated)
Bundesamt fur Sicherheit im Gesundheitswesen 
Beats per minute (heart rate)
Cluster of differentiation 38 (antigen expressed on malignant plasma cells)
Total body clearance
Apparent maximum serum concentration
Central nervous system
Complete response
Clinical Research Organization
Common Terminology Criteria for Adverse Events
Dexamethasone
Dose limiting toxicity
Deoxyribonucleic acid
Data Monitoring Committee
European Group for Blood and Marrow Transplantation
Electrocardiogram
Electronic data capture
Ethylenediamine tetraacetic acid
Enzyme-linked immune-sorbent assay
European Medicines Agency
End of Study
European Organisation for Research and Treatment of Cancer
Electronic Case Report Form
Free light chain
Follicle stimulating hormone
Females of child bearing potential
Good Clinical Practice
Granulocyte colony-stimulating factor
Gamma-glutamyltransferase
Hepatitis B surface antibody
Hepatitis B surface antigen
Hepatitis C virus
Human immunodeficiency virus
Heart rate
Investigator’s Brochure
International Conference on Harmonisation
International Committee of Medical Journal Editors
Sponsor: MorphoSys AG 
Confidential 
Page 24 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
ID
IEC
IFN-y
Ig
IL-2
IL-6
IMiD
IMP
IRB
IV
IWRS
A,z
LEN
LLQ
MABEL
MedDRA
MM
MR
MTD
NaCl
NCI
NK
NOAEL
NYHA
ORR
OS
PBMC
PD
PEI
PFS
PK
POM
PR
PR (ECG)
PT
QLQ
QRS
QT
QTc
RBC
RNA
rpm
RR
SAE
SCID
sCR
SD
SOP
SmPC
SUSAR
t 1/2
TEAE
Identification
Independent Ethics Committee
Interferon-y
Immunoglobulin
Interleukin-2
Interleukin-6
Immunomodulatory derivative 
Investigational medicinal product 
Institutional/Independent Review Board 
Intravenous
Interactive web response system 
Apparent terminal rate constant 
Lenalidomide
Lower limit of quantification
Minimal anticipated biological effect level
Medical Dictionary for Regulatory Activities
Multiple myeloma
Minimal response
Maximum tolerated dose
Sodium chloride
National Cancer Institute
Natural killer
No observed adverse effect level 
New York Heart Association 
Overall response rate 
Overall survival
Peripheral blood mononuclear cell
Progressive disease
Paul Ehrlich Institut
Progression-free survival
Pharmacokinetic
Pomalidomide
Partial response
PR interval
Prothrombin time
Quality of Life Questionnaire
QRS interval
QT interval
QT interval corrected
Red blood cell
Ribonucleic acid
Respirations per minute (respiration rate)
RR interval
Serious adverse event
Severe combined immune-deficient mice
Stringent Complete Response
Stable disease
Standard Operating Procedure 
Summary of Product Characteristics 
Suspected unexpected serious adverse reaction 
Apparent terminal half-life 
Treatment-emergent adverse event
Sponsor: MorphoSys AG 
Confidential 
Page 25 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
tm a x
TNF-a
TSH
TTP
ULN
VGPR
VTE
Vz
WBC
WHO-DDE
Time to maximum serum concentration
Tumor necrosis factor alpha
Thyroid stimulating hormone
Time to progression
Upper limit of normal
Very good partial response
Venous thrombotic event
Volume of distribution during the terminal phase
White blood cell
World Health Organization-Drug Dictionary Enhanced
Sponsor: MorphoSys AG
Confidential
Page 26 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
4 
BACKGROUND
Despite the approval of the novel therapeutic agents pomalidomide (POM) and lenalidomide 
(LEN) for relapsed disease, multiple myeloma (MM) remains an incurable malignancy. One of 
the most strongly and uniformly expressed antigens on malignant plasma cells is CD38 (“cluster 
of differentiation 38”), a cell-surface antigen which is known to have dual functions, both as a 
surface antigen and as an enzyme. Because of this expression pattern, an anti-CD38 antibody 
may have clinical utility as a new therapeutic approach to myeloma treatment.
Relapsed and refractory myeloma, which is associated with median survival rates of less than 
30 months in most studies (Chanan-Khan 2010) and progressively lower response rates to 
therapy, remains an unmet medical need. Further improvements in overall response, duration of 
clinical benefit, progression-free survival (PFS), and overall survival (OS) are desirable, and 
even minimal responses to therapy may be associated with symptomatic benefit.
4.1 Overview of MOR03087
MOR03087 is a fully human recombinant monoclonal antibody directed to CD38 that has 
demonstrated in vitro and in vivo efficacy in preclinical MM models. Antibody-dependent 
cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) are the 
proposed principal modes of action for MOR03087-induced lysis of MM cells. In vitro binding 
studies showed that the binding affinity of MOR03087 to CD38 is in the nanomolar range. The 
in vivo efficacy of MOR03087 was demonstrated in MM xenograft models in severe combined 
immune-deficient (SCID) mice. MOR03087 increased survival and reduced bone lysis induced 
by MM cells inoculated into the tibiae of SCID mice. In vitro and in vivo combination studies of 
MOR03087 with the immunomodulatory derivative (IMiD) LEN suggested an at least additive 
cytotoxicity on myeloma cell lines, providing a preclinical rationale for exploring combination 
therapy with this drug class in myeloma patients.
Aside from malignant plasma cells, CD38 is known to be expressed on natural killer (NK) cells, 
hematopoietic progenitor cells, and some T cell subsets. In vitro secondary pharmacodynamic 
studies did not indicate a MOR03087-mediated decrease of CD38+ myeloid progenitor cell 
colony formation. In human whole blood ex vivo assays there was no evidence for a lytic 
potential of MOR03087 on either human erythrocytes or leukocytes. In an in vitro ADCC assay 
using purified human NK cells, high concentrations of MOR03087 slightly reduced the number 
of NK cells. No stimulatory or inhibitory effects on aggregation of human platelets were 
observed in human whole blood ex vivo.
On human peripheral blood mononuclear cells (PBMCs) no agonistic effects were observed 
following antigen binding or antigen crosslinking. MOR03087 caused a weak dose-related 
release of interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-a) similar to the IgG1 
isotype control, which suggests an antigen-independent effect. For interleukin-2 (IL-2) and 
interferon-y (IFN-y), no induction was observed. PBMC proliferation was not affected.
Species differences in CD38 expression on hematologic cells were noted. An approximately 
60-fold higher CD38 expression was identified on cynomolgus monkey erythrocytes compared 
to humans. Anemia was observed in vivo in the cynomolgus monkey following single dose 
administration of MOR03087, which could reflect increased clearance due to high expression 
levels of CD38 on erythrocytes. In the marmoset monkey, CD38 expression on erythrocytes was 
2.5- to 16-fold lower than that on human erythrocytes. No changes in erythrocyte counts were 
observed in marmoset monkeys in a 12-week toxicity study.
Sponsor: MorphoSys AG
Confidential
Page 27 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Similarity of CD38 expression on human and marmoset monkey PBMC subpopulations 
(granulocytes, monocytes, and lymphocytes) was observed. In the cynomolgus monkey, reduced 
NK cell numbers were noted after single dosing. In the marmoset monkey, no relevant changes 
in corresponding cell numbers were detected.
Regarding platelets, marmoset monkey platelets had an approximately 3-fold higher CD38 
expression than did human platelets. There was no effect upon platelet functionality in either 
human or marmoset monkey whole blood ex vivo.
Based on these comparisons, the high sequence identity between marmoset monkey and human 
CD38 protein, the comparable binding affinity of MOR03087 to human and marmoset monkey 
CD38, and a similar activity to induce ADCC in CD38 target cells by human and marmoset 
monkey PBMCs, the marmoset monkey was selected as the relevant species for the safety 
assessment of MOR03087.
A pivotal 12-week repeat dose toxicity study was conducted in the marmoset monkey with 
MOR03087 (once weekly intravenous [IV] administration). Systemic exposure to MOR03087 
based upon mean area under the serum concentration vs. time curve from time 0 to the time t of 
the last quantifiable concentration (AUC0-t) and apparent maximum serum concentration (Cmax) 
increased in an approximately dose-proportional manner in both males and females. In both the 
mid and high dose groups, the unscheduled death of one male animal was observed. However, 
these were regarded as spontaneous events that were probably not related to the test item 
administration. Main findings in the treatment groups included soft feces/diarrhea and platelet 
reduction. A reversibility of these findings at the end of the recovery period was suggested. The 
increased incidence of subacute inflammation in the cecum and colon of the animals observed 
in the 12 and 50 mg/kg treatment groups was not fully reversed at the end of the recovery period. 
A No observed adverse effect level (NOAEL) was set at 3 mg/kg/dose.
There is no human experience with MOR03087, and the planned Phase I/IIa study of MOR03087 
will serve as the first study of this agent in humans.
4.2 Rationale for Dose Selection
The selection of the starting dose of 10 pg/kg is based on a minimal anticipated biological effect 
level (MABEL) approach taking into account the potential binding of MOR03087 to peripheral 
blood cells. The resulting Cmax is approximately 0.2 pg/mL at the starting dose of 10 pg/kg. The 
calculation of serum concentrations of MOR03087 associated with the starting dose is based on 
a conservative approach excluding the tumor compartment as target tissue. A concentration of 
0.2 pg/mL is too low to mediate ADCC of peripheral blood cells, as derived from the in vitro 
whole blood cell assay. In this assay, peripheral blood cells were not affected at concentrations 
of up to 100 pg/mL. In comparison, ADCC activity towards MM cells was observed at 
concentrations of 1 pg/mL and above.
Taken together, these data suggest that a starting dose of 10 pg/kg will not result in cytotoxic 
effects upon peripheral blood cells. Furthermore, the predicted Cmax in human subjects at a dose 
of 10 pg/kg is expected to be 200-fold lower than the respective values at NOAEL in marmosets.
The dose escalation scheme and the maximum proposed dose are supported by the 3-month 
repeated-dose toxicity study in marmoset monkeys. Based on pharmacokinetic (PK) simulations, 
the predicted human exposure (based on the area under the serum concentration vs. time curve
Sponsor: MorphoSys AG
Confidential
Page 28 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
[AUC]) after weekly administration of 16 mg/kg MOR03087 is comparable to the exposure 
observed in the highest dose group (50 mg/kg) in the marmoset monkey during the 3-month 
repeated dose toxicity study.
For simulating the exposure under a weekly dosing of 16 mg/kg MOR03087 in humans 
(including a loading dose on study Day 4), two different scenarios were set up. For scenario 1, a 
model based on a standard PK profile of a monoclonal human antibody in humans assuming a 
terminal elimination half-life of 14 days and a volume of distribution comparable to the blood 
volume was established. For scenario 2, the exposure was simulated using a clearance rate based 
on allometric scaling. For both scenarios, no target mediated sink effect in MM patients was 
taken into account. A broader volume of distribution caused by a sink effect should lead to a 
significantly lower exposure of free drug in MM patients compared to the simulation. This effect 
should further increase the distance to the observed exposure of the highest dose group in the 
toxicological study.
Based on these modelling approaches, the sponsor considers the predicted human exposure for 
two treatment cycles of weekly MOR03087 at 16 mg/kg (including a loading dose on study 
Day 4) to be comparable to the highest exposure tested in the 3-month repeated dose toxicity 
study in the marmoset monkey. Furthermore, in all simulations the modelled Cmax values of 
MOR03087 following the administration of 16 mg/kg on a weekly basis were at least 10-fold 
lower than the Cmax observed in the marmoset monkey at 50 mg/kg.
According to the International Conference on Harmonisation (ICH) S9 guideline, the highest 
dose or exposure tested in the nonclinical studies does not limit the highest dose investigated in 
a clinical study in subjects with cancer. Also, treatment can continue according to the subject’s 
response beyond the duration of the completed toxicology studies. The sponsor therefore 
considers it appropriate that subjects treated with 16 mg/kg MOR03087 weekly may continue 
with treatment until disease progression as outlined in the current approved version of the study 
protocol. Scheduling in the monitoring of relevant safety parameters as (i.e., addition of thyroid 
stimulating hormone [TSH] and follicle stimulating hormone [FSH] on study Day 29) considered 
in the clinical study protocol will be adapted to the weekly dosing where required. In the 
combination parts (POM/dexamethasone [DEX] and LEN/DEX), the starting dose of 
MOR03087 will be 8 mg/kg, with standard doses of POM, LEN and DEX. Enrolment in these 
parts will not be initiated until approval has been given by an independent Data Monitoring 
Committee (DMC), based on safety data obtained during completion of treatment with 8 mg/kg 
MOR03087 weekly, with and without DEX (cohorts 7b and 7c), thereby ensuring the safety of 
this dosing regimen before adding additional agents.
5 
STUDY PURPOSE/RATIONALE
The purpose of this study is to characterize the safety profile and preliminary efficacy of 
MOR03087 and establish the maximal tolerated dose (MTD) or recommended dose of 
MOR03087 as monotherapy and in combination with DEX as well as in combination with 
standard IMiD therapy (MOR03087 + POM/DEX and MOR03087 + LEN/DEX) in adult 
subjects with relapsed or refractory myeloma.
Despite recent advances in the field, MM remains incurable and eventually all patients will 
become refractory to treatment. Further improvements in overall response, duration of clinical 
benefit, progression-free survival, and overall survival are desirable, and even minor responses
Sponsor: MorphoSys AG
Confidential
Page 29 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
to therapy may be associated with symptomatic benefit in subjects with relapsed or refractory 
MM.
Novel synergistic combinations of anti-myeloma drugs with different modes of action may be 
warranted to overcome drug resistance and improve patient outcome (Jagannath 2010). This is 
especially true for patients with relapsed or refractory MM showing a decreased response rate in 
comparison to treatment-naive patients. In contrast to conventional chemotherapeutic agents, 
monoclonal antibodies as a targeted therapy are ideal for use in combination therapy, with 
potential for decreased toxicity.
LEN, an immunomodulator, has been described in myeloma to inhibit angiogenesis, induce 
apoptosis, decrease binding of MM cells to endogenous marrow stromal cells, and modulate 
cytokines in the bone marrow (Laubach 2009). In vitro studies have shown augmentation of both 
the adaptive and innate immune systems via the costimulation of T-cells and enhanced NK cell 
ADCC activity in the presence of LEN. MOR03087-induced ADCC has been demonstrated to 
be enhanced by LEN in vitro.
POM is a novel immunomodulatory drug recently approved for the treatment of relapsed and 
refractory MM. The pleiotropic activities of POM on a range of cell types, including MM cells 
and immune effector cells, suggest modulation of multiple molecular pathways. POM shares a 
number of the beneficial pharmacologic properties of thalidomide and LEN.
Corticosteroids such as prednisone and DEX were shown to have significant single-agent 
activities (Mass 1962; Alexanian 1992). Moreover, responses to immunomodulatory drugs and 
proteasome inhibitors increase significantly when they are combined with additional agents 
including glucocorticosteroids and chemotherapeutic agents such as alkylators (Alexanian 
1969). For example DEX enhances the anti-myeloma effect of LEN (Minnema 2010), and has 
been reported to induce apoptotic signalling pathways in MM cells leading to growth arrest and 
induction of apoptosis (Chauhan 2002).
In light of the need for more effective treatment options for patients with relapsed/refractory 
myeloma, this study will allow for determination of a MTD or recommended dose, and a 
recommended dosing regimen, of MOR03087 alone, in combination with DEX, and in 
combination with DEX and standard IMiD therapies approved for relapsed MM (POM and 
LEN). To effectively monitor the safety profile of the study subjects, an independent DMC will 
be utilized for dose escalation decisions.
6 
OBJECTIVES
6.1 Primary Objectives
• 
To assess the safety profile and to establish the MTD and/or recommended dose of 
MOR03087 in subjects with relapsed or refractory MM:
a. As monotherapy
b. In combination with DEX
c. In combination with POM+DEX
d. In combination with LEN+DEX
• 
To assess the immunogenicity of MOR03087
Sponsor: MorphoSys AG
Confidential
Page 30 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
6.2 Secondary Objectives
• 
To evaluate the pharmacokinetics and pharmacodynamics of MOR03087 in subjects with 
relapsed or refractory MM:
a. As monotherapy
b. In combination with DEX
c. In combination with POM+DEX
d. In combination with LEN+DEX
• 
To evaluate the preliminary efficacy of MOR03087 in subjects with relapsed or refractory 
MM:
a. As monotherapy
b. In combination with DEX
c. In combination with POM+DEX
d. In combination with LEN+DEX
7 
STUDY DESIGN
7.1 Overall Study Design and Investigational Plan
This is an open-label, multicentre, standard 3+3 dose-escalation study designed to characterize 
the safety profile and to assess the preliminary efficacy of MOR03087 in adult subjects with 
relapsed or refractory MM as monotherapy and in combination with DEX or standard IMiD 
therapy (POM and LEN). Approximately 10-15 sites will participate in this study.
The MTD and/or recommended dose and dosing regimens will be confirmed in a confirmation 
cohort of at least 6 subjects. A total of up to 126 subjects may participate in the study (including 
dose escalation and confirmation cohorts).
The overall study design for the latter stages of the study is indicated in Figure 1. A study flow 
chart for individual subjects is provided in Figure 2.
Sponsor: MorphoSys AG
Confidential
Page 31 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Cohort 8 
q2w
16 mg/kg 
(>3pts)
Cohort 6b 
q1w  
4 mg/kg 
(>3pts)
Cohort 7b 
q1w  
8 mg/kg 
(>3pts)
Cohort 8b 
q1w
16 mg/kg 
(>3pts)
M onotherapy 
Confirm ation Cohort 
Recom m ended dose/schedule 
q2w  or q1w  or q1w/q2w+DEX 
(>6 pts)
Cohort 6c
q 1w
4 mg/kg 
+DEX 
(>3pts)
Cohort 7c
q 1w
8 mg/kg 
+DEX 
(>3pts)
Cohort 8c 
q1w /q2w  
16 mg/kg 
+DEX 
(>3pts)
Cohort 7d
Cohort 8d
Confirm ation Combo
8 mg/kg q1w
16 mg/kg q1w /q2w
Recom m ended dose
+PO M  +DEX
+PO M  +DEX
PO M  +DEX
(>3 pts)
(>3 pts)
(> 6 pts)
Cohort 7e
Cohort 8e
Confirm ation Combo
8 mg/kg q1w
16 mg/kg q1w /q2w
Recom m ended dose
+LEN +DEX
+LEN  +DEX
LEN  +DEX
(>3 pts)
(>3 pts)
(> 6 pts)
q2w: every 2 weeks; q1w: every week; POM: pomalidomide; LEN: lenalidomide; DEX: dexamethasone 
Figure 1: 
Overall Study Design, Dose Levels 6, 7, 8, and Confirmation Cohorts
without PD
Figure 2: 
Overall Study Design, Individual Subject Treatment
MM: multiple myeloma; PD: progressive disease; SD: stable disease
Sponsor: MorphoSys AG
Confidential
Page 32 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Part A: M O R 03087 dose escalation (bi-w eekly treatm ent):
Up to 8 dose levels of MOR03087 will be evaluated:
• 
Cohort 1 - Dose level 1: 0.01 mg/kg
• 
Cohort 2 - Dose level 2: 0.04 mg/kg
• 
Cohort 3 - Dose level 3: 0.15 mg/kg
• 
Cohort 4 - Dose level 4: 0.5 mg/kg
• 
Cohort 5 - Dose level 5: 1.5 mg/kg
• 
Cohort 6 - Dose level 6: 4.0 mg/kg
• 
Cohort 7 - Dose level 7: 8.0 mg/kg
• 
Cohort 8 - Dose level 8: 16.0 mg/kg
Each 28-day cycle will consist of:
MOR03087 infusion on Day 1 and Day 15 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle.
At least 48 hours will pass between the first study drug administration to the subjects within a 
cohort in order to observe for adverse events (AEs).
Part B: M O R 0 3 0 8 7  dose escalation (w eekly treatm ent):
• 
Dose level 6b: 4.0 mg/kg
• 
Dose level 7b: 8.0 mg/kg
• 
Dose level 8b: 16.0 mg/kg
Each 28-day cycle will consist of:
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle.
Part C: M O R 03087 dose escalation (w eekly/biw eekly treatm ent) p lu s low  dose o f  D E X :
• 
Dose level 6c: 4.0 mg/kg
• 
Dose level 7c: 8.0 mg/kg
• 
Dose level 8c: 16.0 mg/kg
Each 28-day cycle will consist of:
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle.
Sponsor: MorphoSys AG
Confidential
Page 33 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Only for dose level 8c, for cycles 4 and onwards each 28-day cycle will consist of:
MOR03087 infusion on Days 1 and 15 of the cycle.
Subjects who have received treatment beyond Cycle 3 will be switched to the biweekly schedule 
at the next Day 1 or Day 15 visit. In exceptional cases -  and after discussion between the 
investigator and the sponsor -  the treating physician may determine that it is in the best interest 
of the subject to remain on the weekly MOR03087 schedule, in which case the sponsor should 
be informed accordingly.
The low dose of DEX is defined as a single dose of 40 mg once to be orally administered on 
Days 1, 8, 15, and 22 with the exception of subjects with > 75 years of age, for whom the 
respective weekly dose should be reduced to 20 mg.
For subjects in Cohort 8c who switch to biweekly MOR03087 treatment from Cycle 4 onwards, 
the DEX treatment schedule will remain unchanged (Days 1, 8, 15, and 22).
If subjects receive glucocorticosteroids at a dose equivalent of 10 mg prednisone (see exclusion 
criterion #15), the total weekly dose of glucocorticosteroids must not exceed 20-40 mg of DEX 
per week. Total dose of DEX should be calculated in accordance with Appendix 18.7.
In Cycle 1 DEX is to be added to the loading dose on Day 4.
Following the completion of Part B dose level 6b and Part C dose level 6c, and taking into 
account available safety information from Part A dose level 8, the DMC will provide 
recommendation if some or all of the planned weekly MOR03087 monotherapy dose escalation 
cohorts will be tested.
Following completion of Parts A, B, and C (dose escalation of MOR03087 bi-weekly and weekly 
regimen), the MTD or recommended dose and schedule will be confirmed in a minimum of 
6 subjects.
Part D: M O R 03087 (w eekly/biw eekly treatm ent) in com bination w ith P O M + D E X
• 
Dose level 7d: 8.0 mg/kg
• 
Dose level 8d: 16.0 mg/kg
Each 28-day cycle will consist of:
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle.
Only for dose level 8d, for cycles 4 and onwards each 28-day cycle will consist of:
MOR03087 infusion on Days 1 and 15 of the cycle.
Subjects who have received treatment beyond Cycle 3 will be switched to the biweekly schedule 
at the next Day 1 or Day 15 visit. In exceptional cases -  and after discussion between the 
investigator and the sponsor -  the treating physician may determine that it is in the best interest 
of the subject to remain on the weekly MOR03087 schedule, in which case the sponsor should 
be informed accordingly.
Oral POM 4 mg on Days 1-21 of the 28-day cycle.
Sponsor: MorphoSys AG
Confidential
Page 34 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Oral DEX 40 mg (< 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of the 
28-day cycle.
For subjects in Cohort 8d who switch to biweekly MOR03087 treatment from Cycle 4 onwards, 
the DEX treatment schedule will remain unchanged (Days 1, 8, 15, and 22).
In Cycle 1 DEX is to be added to the loading dose on Day 4.
Part E: M O R 03087 (w eekly/biw eekly treatm ent) in com bination w ith L E N + D E X
• 
Dose level 7e: 8.0 mg/kg
• 
Dose level 8e: 16.0 mg/kg
Each 28-day cycle will consist of:
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle.
Only for dose level 8e, for cycles 4 and onwards each 28-day cycle will consist of:
MOR03087 infusion on Days 1 and 15 of the cycle.
Subjects who have received treatment beyond Cycle 3 will be switched to the biweekly schedule 
at the next Day 1 or Day 15 visit. In exceptional cases -  and after discussion between the 
investigator and the sponsor -  the treating physician may determine that it is in the best interest 
of the subject to remain on the weekly MOR03087 schedule, in which case the sponsor should 
be informed accordingly.
Oral LEN 25 mg on Days 1-21 of the 28-day cycle.
Oral DEX 40 mg (< 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of the 
28-day cycle.
For subjects in Cohort 8e who switch to biweekly MOR03087 treatment from Cycle 4 onwards, 
the DEX treatment schedule will remain unchanged (Days 1, 8, 15, and 22).
In Cycle 1 DEX is to be added to the loading dose on Day 4.
Following completion of Parts D and E (dose escalation of MOR03087 in combination with 
POM+DEX and LEN+DEX), the MTD and/or recommended dose in each part will be confirmed 
in a minimum of 6 subjects.
A ll cohorts:
After the first administration of study drug, the subjects will remain at the site until the end of 
Day 2 for safety monitoring. The subjects will not stay overnight at the site for subsequent 
administrations.
Based on the individual risk/benefit ratio, subjects who have an ongoing response of at least 
stable disease (SD) may continue treatment with the assigned study regimen until disease 
progression or until a maximum of 3 years after first treatment. In case subjects present with 
progressive disease or with no better status than SD after four treatment cycles starting with 
Cycle 1 Day 1, the investigator may add a low weekly dose of DEX to the regimen at his/her 
discretion, provided DEX is not already part of the treatment regimen.
Sponsor: MorphoSys AG
Confidential
Page 35 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
At least 3 subjects meeting all inclusion and none of the exclusion criteria, as determined at the 
screening visit (see Sections 8.1 and 8.2) will be enrolled into each cohort.
Enrolment into a cohort at the next higher dose level will be based on the data generated from 
the previous dose level and guided by clinical review until
• 
the maximum planned dose has been reached, or
• 
the review of the safety data indicates a need to either expand the current dose level 
cohort to include 6 subjects or stop the dose escalation or the study, or
• 
the review of Part B dose level 6b and Part C dose level 6c, including available safety 
information from Part A dose level 8, indicates that only some of the planned weekly 
MOR03087 monotherapy dose escalation cohorts should be tested.
The DMC safety review will take place after the third subject enrolled into a cohort has 
undergone minimum safety evaluations (as defined for the “DLT Evaluable Population” in 
Section 15.1). The safety assessment will take into account AEs reported from Day 1 after the 
start of the first infusion through Day 29 before the start of the second cycle. The next cohort 
will only be started after the positive outcome of the safety assessment.
Cohort expansion up to 6 subjects will be allowed if a dose limiting toxicity (DLT) (as defined 
in Section 8.5) is observed in 1 of 3 subjects. If 2 or 3 subjects experience a DLT in cohorts 6b 
or 6c, the study sponsor may decide to test a lower dose. If 2 or 3 subjects of the 3 subjects in 
any of the other cohorts experience DLT, then the previous cohort should be expanded to 
6 subjects.
A pharmacokinetic interim analysis may be performed at any time during dose escalation if 
unexpected MOR03087 serum concentration results are observed. The rationale for performing 
the pharmacokinetic interim analysis is to verify whether the derived pharmacokinetic 
parameters from this interim analysis (e.g., Cmax, AUC, terminal elimination half-life, etc.) are 
still within the expected range. If there are major deviations from the expected values, it may be 
considered necessary to investigate a further dosing regimen or to expand the dose escalation 
including further cohorts via a substantial amendment to the protocol.
After study drug discontinuation due to reason other than disease progression, all subjects will 
return for a follow-up visit 1 and follow-up visit 2. Further follow-up visits will be conducted at 
4-week intervals until the subject is progressive, begins subsequent anti-myeloma therapy, or 
dies.
All subjects will be followed up for a maximum of 3 years after first administration of study 
drug.
Study visits will be conducted according to the Schedules of Assessments provided in Table 1 
(for subjects receiving bi-weekly MOR03087 treatment) and Table 2 (for subjects receiving 
weekly/bi-weekly MOR03087 treatment).
Sponsor: MorphoSys AG
Confidential
Page 36 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Table 1 Flow Chart and Schedule of Assessments: Part A (Bi-weekly Administration)
Treatment (Tx) Cycle 1 (Days 1-28)
Tx Cycle 2 (Days 29-56)
Evaluation or Procedure
Screening
D1
D2
D4
D8
D15
D22
D29
D36
D43
D50
(< 4 weeks
±1
±1
±1
C2D1
C2D8
C2D15 C2D22
before
day
day
day
±1
±1
±1
±1
Day 1)
day
day
day
day
Informed consent
\
Medical history'
\
I )emography
\
1 
1
Inelusion/exciusion criteria
\
X 4
karnolsky performance status
\  
|
x 4
x 4
Premedication
X"
X"
X"
X"
X"
| Study drug administration (2-hour
x  
1
X
X
1 
x
X
| infusion)
Tx Cycles 3+ 
Visit:
repeated bi­
weekly 
(± 2 days)
Follow-up 
Visit 1 
(4 weeks 
± 2 days after 
last dose)
Follow-up Visit 2 
(4 weeks ± 2 days 
after Follow-up 
Visit 1)1
EOS
Visit2
X5
" x r
! Laboratory
‘'Emergency laboratory”7 
| Hematology 
| Serum chemistry 
[Coagulation
| fll ICO pregnancy test for women of 
| childbearing potential 
| Urine pregnancy test for women of 
| childbearing potential4 
| Urinalysis
; Pharmacokinetics (MOR03087)
! Endocrinology (TSH, FSH) 
iAnti-MOR03087 antibodies14 
IB, T, and NIC cells
| Serum and urine M-protein18, serum free 
Night chains 
| Response Assessment20 
| Cytokines
| Flow cytometry analysis of peripheral 
| MM cells 
| Serology22
| Bone/skeletal survey23 
| Bone marrow (Histology)
| Biomarker sample (bone marrow)
i X8 i
! X8 !
! X8 !
! X8 !
X8
1
X
i
i
1
"x...
X4
"x..." X4 ' .X....' X4 ' ..x...
X4 ' .X..
X4
.X...I.........X........ i....
\
...........X............|.....x"
x9..
X4
x : ; x4 ; ix ;::’ x4 ; ix i:
X4 ■X
X4
.X...1...XIIxIIII... I....
\
IIIX III^
...|.....x"
ix i:I j l l l l l j l ”
x4 ;
Illlllljl iiiiix i
iiiijiiii
\
ZJIIZK.
X
X
X
x
x
x
.1.........1............
X5
...[... .................
...........
ix i:
' X4
X4 '
.t.........i............
...t... ................
...1.....x"
X'U
x" ;
; x" ;
X11 '
X"
.X...I.. :::;xi2:::i...i...
\
xn
"x.....i.........i..
I 
i
X4
.......i..
...i...
\
...i.....x"
"x.....i.........i..
’ x4 ’
i 
i
X4
.......i.. XIIxXII...i...
\
......... X10...........|.....x"
' E I l I .
[ I  I]
x4-17;
I I I]
I I
IIIXIII
X1"
IIIX III^
I Xx
X19
X4
x4
x4
X4
x5- 20
X
X
x
..1.........1..
! x i
.t........ i........1.. :::x 2,:::i...t...
\
...I.....x"
X21
XIIIIIX
Illlllljl IIIIT I
IIIXIIIIIIIIIIIIIIIIIIIJI
IIXIIIII
X
x
"x.....i...........
1........i.
.i........ i...........
...i... ....................
...........
"x...
i 
i
.......i...
...I.....x"
x24..
1..x25..i.
.......i..
...1........
x24..IIIIIIIIIICZ
1........ i.
IEIIIIIX IIIIIXI
IIIXIIIIIIIIIIIIIIIIIIIII
...I.........
Sponsor: MorphoSys AG
Confidential
Page 37 of 143
X
X
X
X


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Table 1 Flow Chart and Schedule of Assessments: Part A (Bi-weekly Administration)
Treatment (Tx) Cycle 1 (Days 1-28) 
| 
I x Cycle 2 (Days 29-56)
Tx Cycles 3+
Follow-up
Follow-up Visit 2
EOS
Evaluation or Procedure
Screening
....1)1..... .... 1)2.... ....1)4.... ....1)8.... ...1)15...||....1)22....|..1)29...!...1)36....[...1)43...|1...1)50...1
Visit:
Visit 1
(4 weeks ± 2 days
Visit2
(< 4 weeks
±1
± 1
± 1
C2D1
C2D8
C2D15 C2D22
repeated bi­
(4 weeks
after Follow-up
before
day
day
day
± 1
±1
± 1
±1
weekly
± 2 days after
Visit l)1
.... Day 1).....
...day... ...day....[...day...|...day....
(± 2 days)
last dose)
jlmmunophenotyping of MM cells (bone | 
x
x 25
j marrow)
CXlogenetics of MM cells (bone marrow)
X24 2(1
|FcyRIIIa polymorphism (mucosal cheek
.... x 4.....
[swab)
Examination and other assessments
Phxsieal examination27
i 
x2s 
1! 
X 4
r i x i j
X4
i.....x.... r...x4....1p x i j
X4 
IL IX III
X
X
X
X2S 
|
Bod> weight and height29
1 
\
! 
X 4
X4
X4
.............:;x4::i
x4
X4
X
X
[ “
X I I I !
Quality of life (QLQ-MY20 +
x4
x4
............ I
x4
x
x
x
QLQ-C30)
............ [
1 leclrocardiogram (1 C(if"
\
J (  
]
............ i
\
X"
X’1
x
Vital signs (blood pressure, pulse rate,
x
x32
X
X 32
x
X 32
x
x32
x
X 32
X
X 32
x
x
x
respiratory rate, body temperature)32
I'oxicily/AE assessment33
1.....x.... 1|.....x.....1.... X.....I.... X .....1[.... X .... 1|.....X .... 1"..... X.....I.... X.....I[.... X .... 1|.....x....|
X
X
X
x
Concomitant medication
t.....x34.....1|....x4.....1|..... X......1
X4
I.....X ..... 1
X4
|..... X .....[..x4...1I.....X ......1
X4
..... X .....1|..............X ..............1[............. X.............. 1|...................X ................... |........X.........1
A follow-up visit will be repeated every fourth week (± 2 days) until progressive disease, or receipt o f new anti-m yelom a treatment, or until death, but no longer than 3 years from the first
study drug administration. Follow-up visits may be delayed for a maximum o f 2 weeks after the normal visit window due to other reasons (e.g., logistical).
2 The EOS visit will occur after at least 28 days after last study drug administration but should be performed before any new M M  therapy starts, whichever occurs first. Subjects who 
complete Cycle 2 but do not receive additional cycles (Cycle 3+) have to perform Follow-up visit 1 and Follow-up visit 2 before EOS visit.
3 Including disease staging based on Durie-Salmon and International Staging System (ISS) criteria and documentation o f immunoglobulin type.
4 Before study drug administration.
5 Each cycle, starting with Cycle 3+: pre-dose at Day 1 (CxD1)
6 During Cycle 1, all subjects should be given prem edication including an antipyretic (e.g., paracetamol) and a histamine H1 receptor blocker according to the local standard o f care. In 
medically justified cases, the investigator may use other medications (e.g., steroids as per local standard but not exceeding 10 mg prednisolone equivalent), doses and/or formulations if this 
is documented thoroughly in the eCRF and the source data. If no infusion reaction occurs during Cycle 1, then prem edication can be stopped at discretion o f the investigator for subsequent 
treatm ent cycles. Otherwise, the prem edication should be continued for subsequent administrations o f M OR03087 as well.
7 Emergency Laboratory only to be taken if hematology/serum  chemistry is not available prior to study drug administration
8 Sample to be taken and evaluated before study drug administration. On Day 1, additional sample (except AST and ALT) to be taken 2 hours after end o f infusion.
9 B2-microglobulin to be measured at Screening only.
10 Pharm acokinetic sample to be taken predose and then at 1, 2, 4, 8, 14±2 (optional), 22±2, and 28±2 hours after start o f first infusion.
11 Pharm acokinetic sample to be taken predose and 2 hours after start o f infusion.
12 Pharm acokinetic sample during treatm ent Cycles 3+ to be taken every 2nd study drug administration (CxD15) predose and 2 hours after start o f infusion.
13 Only if subject had no follow-up visit.
14 Samples for anti-M OR03087 antibodies will also be used to determine tetanus titer if sufficient quantities o f serum are available.
Sponsor: MorphoSys AG 
Confidential 
Page 38 of 143


15 Each cycle, starting w ith Cycle 3+: pre-dose at Day 15 (CxD15)
16 A t second follow -up visit only.
17 Including CD16 expression on N K  cells.
18 For urine M -protein evaluation, 24-hour urine has to be collected.
19 For urine M -protein evaluation at Screening, use o f pre-collected 24h urine sample w hich M M  subjects bring to the hospital for every routine visit w ithin the scope o f usual standard o f 
care procedure is accepted.
20 Evaluation on Day 1 o f every cycle (CxD1). A ll response categories require two consecutive assessm ents m ade at any tim e prior to the start o f any new  therapy.
21 Sample to be taken before study drug adm inistration and 2 hours after end o f study drug administration.
22 H epatitis B and C.
23 W here m edically indicated, as a regular assessm ent o f standard o f care in subjects w ith relapsed or refractory M M , x-ray, CT, or M RI imaging o f the bone w ill be conducted.
24 Results from bone m arrow  exam ination done w ithin 28 days prior to first dose are acceptable, if the subject has been hematologically stable since then.
25 Bone m arrow  on Day 29 (C2D1) is to be assessed only if specific consent for this assessm ent has been provided.
26 Only if no historical data are available. First or second bone m arrow  aspiration sample should be used.
27 Physical exam ination w ill include basic neurological examination o f general m otor and sensory systems, mental status, cranial nerves, and coordination.
28 The physical exam ination should include an ocular exam ination by an ophthalm ologist (including distance visual acuity, optical coherence tom ography [if available], and ophthalmoscopy 
under full m ydriasis [if optical coherence tom ography is unavailable]).
29 H eight at screening only.
30 12-Lead ECG  recording w ith determ ination o f heart rate and RR, PR, QRS, QT, and QTc intervals.
31 ECG  assessm ents in Follow-Up V isits are to be conducted only if clinically indicated, per the investigators’ discretion.
32 A t Cycles 1 and 2 at study drug adm inistration visits: immediately before infusion; 15 minutes, 30 minutes, and 1 hour after start o f infusion; at end o f infusion; and 2 and 4 hours after end
o f infusion. From  Cycles 3+ on: only before and at end o f infusion.
33 Infusion reactions, cytokine release syndrome, and allergic reactions to M OR03087 should be reported w ith respective sym ptom s (e.g., infusion reaction— hives, chills, fever).
34 Including history o f previous m yeloma-specific therapies and prior m edications.
Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Sponsor: MorphoSys AG
Confidential
Page 39 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Table 2 Flow Chart and Schedule of Assessments: Parts B-E (Weekly/Biweekly Administration)
Treatment (Tx) Cycle 1 (Days 1-28)
Evaluation or Procedure
Screening
D1
D2
D4
D8
D15
D22
(< 4 weeks
±1
±1
±1
before
day
day
day
Day 1)
Informed consent
\
Medical history '
\
1....................1....................
POM or LEN educational leaflet and
i 
V
1
Pregnancy Counselling
....................1.................... 1
Demography
\  
|! 
1
Inclusion/exclusion criteria
\
X 4
kamolsky performance status
\
X 4
Pruned icalion
X "
X '
X "
X "
X '
Study drug administration MOR03087
i 
X 
!
1.......x........ |
X
X
I........x"
Slud\ drug administration DEX tablet
1........x....... 1.................... 1
X
X
[ p > r
Study drug administration (LEN capsule
I 
V
I 
V
X
X
X
/ POM capsule) and prophylaxis8 
|
Laboratory
"Emergency laboratory’"'
! 
X10 
!
' 
X1"
X ' U
X ' U
X 1
1 lemalology
\
! 
X4
1 
X
\ 4
X 4
X 4
X 4
Serum chemistry
X "
! 
X4
........x........|
X 4
X 4
X 4
X 4
Coagulation
\
|....................|....................
[31 ICO pregnancy test for women of
X12
! childbearing potential 
|
.........................................
Urine pregnancy test for women of 
j
X12
X14
X14
X14
childbearing potential4
| Urinalysis 
|
\
X 4
Pharmacokinetics (MOR03087)
! 
x15
X "
X 1"
X 1"
X "
Pharmacokinetics (1.1 N/POM)
................ X
'i'y................
X 1"
1 ndocrinolog> ( fSI 1. ESI 1)
\
1 
1
Anli-M()R()3087 antibodies-1"
\
1
X 4
IE 1. and Nk cells 
|
X 2'
....................1....................
X 4
Serum and urine M-protein25, serum free
X26
X4 
1
X4
light chains 
|
Response assessment27
! 
1
C\lokincs
i: ; x 28:
j : : :
: :
i
Tx Cycle 2 (Days 29-56)
Tx Cycles 3+
Follow-up
Follow-up Visit 2
EOS
D29
D36
D43
D50
Visit:
Visit 1
(every 4 weeks
Visit2
C2D1
C2D8
C2D15 C2D22
repeated
(4 weeks
± 2 days after
±1
±1
±1
±1
weekly
± 2 days after
Follow-up Visit l)1
day
day
day
day
(biweekly from
last dose)
Cycle 4,
CxDl/D15)
| 
± 2 days
x 4
x 4-5
X 4
X s
\
\
x
X"
X'
X"
1....x s.....
X"
1....x .....!|.....X..... 1
\
|.....X.....
x
p x “j [Px™J
x
t 
X
x
X
X
X
X
X1
X 'U
X 1" 
I
X1
x
X 4
X 4
X 4
! 
X4
x
\
\
x
X 4
X 4
X 4
i 
X4
x
\
\
x
X 4
\
x 
1
x 13
x
x
X4
X5
X 4
X
x"
X "
x 1"
j 
X16
X 1
\
■ 
X18
x "
X 1"
p x “j
X 4
\
x
X 4
X 21
\
X 22
x
X 4
X 24
x :
\
x 
1
X 4
X 4
X 5-27
x
x
x
I......X .......I
1............... x 27................ !I................ X ..................II........................X ........................I..........X........... 1
Sponsor: MorphoSys AG
Confidential
Page 40 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Table 2 Flow Chart and Schedule of Assessments: Parts B-E (Weekly/Biweekly Administration)
Treatment (Tx) Cycle 1 (Days 1-28) 
| 
I x Cycle 2 (Days 29-56)
Tx Cycles 3+
Follow-up
Follow-up Visit 2
EOS
Evaluation or Procedure
Screening ....1)1.... ....1)2... ....1)4.... ....1)8.... ...1)15...1|....1)22... |..1)29...!...1)36... [...1)43....1...1)50...1
Visit:
Visit 1
(every 4 weeks
Visit2
(< 4 weeks
±1
± 1
± 1
C2D1
C2D8
C2D15 C2D22
repeated
(4 weeks
± 2 days after
before
day
day
day
±1
±1
±1
±1
weekly
± 2 days after
Follow-up Visit l)1
Day 1)
day
day
day
day
(biweekly from
last dose)
Cycle 4,
| 
CxDl/D15)
± 2 days
Flow cytometry analysis of peripheral
x
X
MM cells
Serology29
| 
\  
|
Bone/skeletal survey30
! 
\
\
Bone marrow (Histology)
i 
X'1
X 2
Biomarker sample (bone marrow)
! 
x '1
Immunophenotyping of MM cells (bone
X31
X32
marrow)
CSlogenetics of MM cells (bone marrow)
X"
FcyRIIIa polymorphism (mucosal cheek
X4
swab)
Examinations and other assessments
Phxsieal examination34
! 
X's
X4
X4
X4
X4
..x4...
X4
X4
X4
X
X
X
x;s 
|
Bodx weight and height36
X
X4
v
X4
X4
X4
: x 4i :
X4
X4
X4
X4
X
X
X
Quality of life (QLQ-MY20 +
X4
x4
.............. 1
X4
x
x
x
QLQ-C30)
j
1 leclrocardiogram (ECG)37
X
X -
|..... X......1
X'-
X'-
x,_
..... X.....1"...X37....
x,_
x,_
..... X.....1
X;'
X s
x;s
X
Venous thrombotic event monitoring39
X
: : x : : [IIX II]
I I x ; : ] l i y i i I I x I I I I X I I i i x i : I I X I I I I X I I ]
X
X
X
X
Vital signs (blood pressure, pulse rate,
X
x40
X
X40
x4,)
x40
X40
X40
X40
X40
X40
X40
X
x
x
respiratory rate, body temperature)
Toxicity/AE assessment41
..... X.....1..... X......1i.....x...... .....X..... 1t.....X..... ..... X.....f....X...... .....X...... .....X..... ..... X.....1
X
X
X
x
Concomitant medication
X42
X4
[IIX II]
x4
X4
X4
I I x I I IIX II i i x i :
X4
I I X I I ]
X
X
X
X 
1
Subsequent anti-myeloma treatment
I I
X4'
1 A Follow-up visit will be repeated every fourth week (± 2 days) until progressive disease, or receipt o f new anti-m yelom a treatment, or until death, but no longer than 3 years from the first 
study drug administration. Follow-up visits may be delayed for a maximum o f 2 weeks after the normal visit window due to other reasons (e.g., logistical).
2 The EOS visit will occur after at least 28 days after last study drug administration but should be performed before any new M M  therapy starts, whichever occurs first. Subjects who 
complete Cycle 2 but do not receive additional cycles (Cycle 3+), have to perform Follow-up visit 1 and Follow-up visit 2 before EOS visit.
3 Including disease staging based on Durie-Salmon and International Staging System (ISS) criteria and documentation o f immunoglobulin type.
4 Before study drug administration.
5 Each cycle, starting with Cycle 3+: pre-dose at Day 1 (CxD1)
6 During Cycle 1, all subjects should be given prem edication including an antipyretic (e.g., paracetamol) and a histamine H1 receptor blocker according to the local standard o f care. In 
medically justified cases, the investigator may use other medications (e.g., steroids for the non-DEX cohorts) as per local standard but not exceeding 10 mg prednisolone equivalent), doses
Sponsor: MorphoSys AG 
Confidential 
Page 41 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
and/or form ulations if this is documented thoroughly in the eCRF and the source data. If no infusion reaction occurs during Cycle 1, then prem edication can be stopped at investigator’s 
discretion o f the investigator for subsequent treatm ent cycles. Otherwise, the prem edication should be continued for subsequent administrations o f M O R03087 as well.
7 DEX should be given up to 3 hours prior to M OR03087 infusion start.
8 Subjects in Parts D and E are to take PO M  or LEN  capsules, respectively, on Days 1-21 o f each treatm ent 28-day cycle. Throm boem bolism  prophylaxis during the study treatm ent is 
required for subjects; low-dose aspirin, low  m olecular w eight heparin, or other equivalent antithrombotic or anti-coagulant w ill be given to all subjects taking PO M  or LEN; Oral 
application o f PO M  or LEN  must be performed at start o f M O R03087 infusion (+/- 5min)
9 Emergency Laboratory only to be taken if hem atology/serum  chemistry is not available prior to study drug administration
10 Sample to be taken and evaluated before study drug administration. On Day 1, additional sample (except A ST and A LT) to be taken 2 hours after end o f infusion.
11 B2-microglobulin to be m easured at Screening only.
12 For subjects treated w ith PO M  or LEN  (Parts D or E), the first pregnancy test m ust be perform ed w ithin 10-14 days prior to the start o f study treatm ent, and a second pregnancy test m ust 
be performed w ithin 24 hours prior to the start o f study treatment.
13 For female subjects w ith irregular cycles treated in Parts D and E (PO M  and LEN), an additional pregnancy test is required 14 days after treatm ent discontinuation.
14 Subjects treated in Parts D and E only (PO M  and LEN): Serum or urine pregnancy test m ust be performed.
15 Pharm acokinetic sample (M OR03087) to be taken predose and then at 1,2 , 4, 8, 14±2 (optional), 22±2, and 28±2 hours after start o f first M O R03087 infusion.
16 Pharm acokinetic sample (M OR03087, LEN  or PO M ) to be taken predose and after com pletion o f M OR03087 infusion.
17 Pharm acokinetic sample during treatm ent cycles 3+ to be taken every CxD15 predose and after com pletion o f infusion.
18 Only if subject had no follow-up visit.
19 Pharm acokinetic sample (PO M  or LEN ) to be taken predose before adm inistration o f M OR03087 + LEN  or PO M  and then at 1,2 , 8, 22±2 hours after start o f first M O R03087 infusion.
20 Samples for anti-M OR03087 antibodies w ill also be used to determine tetanus titer if sufficient quantities o f serum available.
21 A nti-M O R03087 antibody sample during treatm ent Cycles 3+ to be taken every CxD15 predose.
22 A t second follow -up visit only.
23 Including CD16 expression on N K  cells.
24 Each cycle, starting w ith Cycle 3+: pre-dose at Day 15 (CxD15)
25 For urine M -protein evaluation, 24-hour urine has to be collected. During the first two cycles more Serum and urine M -protein, serum free light chains will be collected.
26 For urine M -protein evaluation at Screening, use o f pre-collected 24h urine sample w hich M M  subjects bring to the hospital for every routine visit w ithin the scope o f usual standard o f 
care procedure is accepted.
27 Evaluation on Day 1 o f every cycle (CxD1). A ll response categories require two consecutive assessm ents m ade at any tim e prior to the start o f any new  therapy.
28 Sample to be taken before study drug adm inistration and 2 hours after end o f study drug administration.
29 H epatitis B and C.
30 W here m edically indicated, as a regular assessm ent o f standard o f care in subjects w ith relapsed or refractory M M , x-ray, CT, or M RI imaging o f the bone w ill be conducted.
31 Results from bone m arrow  exam ination done w ithin 28 days prior to first dose are acceptable, if the subject has been hematologically stable since then.
32 Bone m arrow  on Day 29 (C2D1) is to be assessed only if specific consent for this assessm ent has been provided.
33 Only if no historical data are available. First or second bone m arrow  aspiration sample should be used.
34 Physical exam ination w ill include basic neurological examination o f general m otor and sensory systems, mental status, cranial nerves, and coordination.
35 The physical exam ination should include an ocular exam ination by an ophthalm ologist (including distance visual acuity, optical coherence tom ography [if available], and ophthalmoscopy 
under full m ydriasis [if optical coherence tom ography is unavailable]).
36 H eight at screening only.
37 12-Lead ECG  recording w ith determ ination o f heart rate and RR, PR, QRS, QT, and QTc intervals. Subjects in Part D (POM ) only: ECG  m onitoring w ill be perform ed on Cycle 3 Day 1, 
and on Day 1 o f every third cycle thereafter (Cycles 3, 6, 9 etc.) and at treatm ent discontinuation. Subjects w ith QT prolongation (or borderline QT prolongation) but otherwise non-
Sponsor: MorphoSys AG
Confidential
Page 42 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
38
39
40
41
42
43
clinically significant w ill require more frequent ECG  monitoring at the discretion o f the investigator. Subjects in Part E (LEN) only: ECG  monitoring w ill be performed at each visit at the 
discretion o f the investigator.
ECG  assessm ents in Follow-Up V isits are to be conducted only if clinically indicated, per the investigators’ discretion.
Clinical review  o f signs/symptoms for possible venous thrombotic events in subjects treated w ith PO M  or LEN. Subjects who develop symptomatic deep vein throm bosis will be assessed 
and diagnosed objectively by D oppler ultrasonography or a comparable m ethod per institution’s standard o f care. See A ppendix 18.9 for deep vein throm bosis and pulmonary embolism 
diagnostic algorithms.
A t Cycles 1 and 2 at study drug adm inistration visits: immediately before infusion; 15 minutes, 30 minutes, and 1 hour after start o f infusion; at end o f infusion; and 2 and 4 hours after end 
o f infusion. From  Cycles 3+ on: before and at end o f infusion
Infusion reactions, cytokine release syndrome, and allergic reactions to M OR03087 should be reported w ith respective sym ptom s (e.g., infusion reaction— hives, chills, fever).
Including history o f previous m yeloma-specific therapies and prior m edications.
Investigators are to record details o f the subjects’ subsequent anti-m yelom a therapy.
Sponsor: MorphoSys AG
Confidential
Page 43 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
7.2 Study Timeframe
The anticipated overall time frame for the study will be approximately 8 years.
7.3 Risks and Benefits to Subjects
MOR03087 provides a novel mechanism of action that may add to the care of MM patients and 
complement standard-of-care treatment. Based on the available data from nonclinical studies and 
experiments as well as literature data on CD38, the sponsor is of the opinion that the potential 
benefit of MOR03087 outweighs the potential risk.
The most likely expected effects—thrombocytopenia, anemia, and diarrhea—are frequently 
encountered events in malignant hematologic practice. The identified potential toxicities can be 
readily monitored and managed, e.g., by platelet and red blood cell transfusion or respective 
treatment of gastrointestinal symptoms. It is expected that the potential risks will be adequately 
controlled by the design of this first-in-human study (e.g., by the inclusion and exclusion criteria) 
and by frequent monitoring of potential side effects throughout the entire study.
Based on the results of the 12-week repeated dose toxicity study in marmoset monkeys, the 
earliest biological effect of MOR03087 expected on non-tumor cells is thrombocytopenia and -  
at higher doses -  diarrhea. Diarrhea was almost reversible at the end of the recovery period. A 
dose-dependent, reversible thrombocytopenia occurred with the first dose and remained stable 
thereafter.
The most common serious adverse reactions in subjects treated with a combination of LEN or 
POM and DEX are venous thromboembolism and grade 4 neutropenia, grade 3 or 4 
thrombocytopenia, and venous thromboembolism (see Summaries of Product Characteristics 
[SmPCs]). It is considered unlikely that neutropenia would be potentiated in combination with 
MOR03087, as neutrophils only express low levels of CD38.
Generally, it cannot be excluded that treatment with LEN and POM may have an additive effect 
on thrombocytopenia when used in combination with MOR03087.
Although the mechanism for thrombocytopenia induced by MOR03087 is unknown, there is no 
preclinical evidence of thrombosis associated with MOR03087 in the marmoset monkey. In 
addition, ex vivo analysis of human and marmoset thrombocytes did not show any signs of 
thrombocyte activation and aggregation by MOR03087.
Close and frequent monitoring of hematological parameters, i.e., complete blood cell count 
including white blood cell count with differential count, platelet count, hemoglobin and 
hematocrit, is implemented in the clinical trial protocol.
White blood cell (WBC) counts will be frequently monitored and anticoagulation treatment is 
mandatory during combination treatment with LEN and DEX, per guidelines.
Other adverse events observed with immunomodulatory agents (i.e., IMiDs) include infection, 
fatigue, renal failure, neuropathy, venous thromboembolic events, and constipation. With POM 
and LEN, there are also risks associated with fetal exposure (see Section 7.3.1).
Adverse reactions of long-term treatment with high doses of glucocorticosteroids may include 
among others: elevation of blood pressure, sodium and water retention, hypothalamic-pituitary
Sponsor: MorphoSys AG
Confidential
Page 44 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
adrenal axis suppression, infections, cataracts, glaucomas, peptic ulcers and myopathies. In the 
current study, stringent criteria have been established to exclude subjects with pre-existing 
clinically significant cardiovascular disease, systemic diseases, coexistent infections or antibiotic 
administration. Study participants will be subjected to close medical scrutiny involving medical 
history collection and frequent physical and laboratory examinations aimed at the early detection 
of adverse events.
More extensive information on the risks and benefits associated with the study drugs is provided 
in the Investigator’s Brochure (IB) for MOR03087, and SmPCs for LEN and POM, which will 
be supplied to the sites. For the information on DEX, please refer to the SmPC of the provided 
brand.
7.3.1 Pregnancy Prevention Risk Minimization Plans
POM and LEN are structurally related to thalidomide. Thalidomide is a known human 
teratogenic active substance that causes severe life-threatening birth defects. An embryofetal 
development study in animals indicates that LEN produced malformations in the offspring of 
female monkeys who received the drug during pregnancy; POM was found to be teratogenic in 
a developmental study in rats and rabbits. A teratogenic effect of POM and LEN in humans 
cannot be ruled out. Therefore, a risk minimization plan to prevent pregnancy must be observed. 
Pregnancy prevention risk minimization plans are provided in Appendix 18.8 and are 
summarized below.
Appendix 18.8.1 applies to all subjects receiving LEN therapy; Appendix 18.8.2 applies to all 
subjects receiving POM therapy. The following Pregnancy risk minimization plan documents 
are included in these appendices:
1) Lenalidomide/Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and 
Acceptable Birth Control Methods;
2) Lenalidomide/Pomalidomide Education and Counseling Guidance Document;
3) Lenalidomide/Pomalidomide Information Sheet.
1. 
The Lenalidomide/Pomalidomide Risks of Fetal Exposure, Pregnancy Testing
Guidelines and Acceptable Birth Control Methods document provides the following
information:
• 
Potential risks to the fetus associated with LEN/POM exposure
• 
Definition of Female of Childbearing Potential
• 
Pregnancy testing requirements for subjects receiving LEN/POM who are females of 
childbearing potential
• 
Acceptable birth control methods for both female of childbearing potential and male 
subjects receiving LEN/POM in the study
• 
Requirements for counseling of all study subjects receiving LEN/POM about 
pregnancy precautions and the potential risks of fetal exposure to LEN/POM
Sponsor: MorphoSys AG
Confidential
Page 45 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
2. The Lenalidomide/Pomalidomide Education and Counseling Guidance Document must 
be completed and signed by either a trained counselor or the Investigator at the 
participating clinical site prior to each dispensing of LEN/POM study treatment. A copy 
of this document must be maintained in the subject records.
3. The Lenalidomide/Pomalidomide Information Sheet will be given to each subject 
receiving LEN/POM study therapy. The subj ect must read this document prior to starting 
LEN/POM study treatment and each time they receive a new supply of study drug.
8 POPULATION
This study will be conducted in adult subjects with refractory or relapsed MM. The planned
sample size will be up to 126 subjects.
The investigator or his/her designee must ensure that only subjects who meet the following
inclusion and exclusion criteria are offered enrolment into the study:
8.1 
Inclusion Criteria For All Subjects
1. Male or female subjects > 18 years of age
2. Presence of serum M-protein > 0.5 g per 100 mL (> 5 g/L) and/or urine M-protein > 200 mg 
per 24-hour period
3. Life expectancy of > 3 months
4. Karnofsky performance status > 60%
5. Absolute neutrophil count (ANC) > 1.0 (1,000/mm3)
6. Total bilirubin < 2 x the upper limit of normal (ULN)
7. Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN
8. Hemoglobin > 8 g/dL
9. If a female of childbearing potential, confirmation of a negative pregnancy test before 
enrolment and use of double-barrier contraception, oral contraceptive plus barrier 
contraceptive, for at least 28 days prior to, during therapy and for 28 days after the last dose, 
or confirmation of having undergone clinically documented total hysterectomy and/or 
bilateral oophorectomy, tubal ligation
10. If a male, he must practise complete abstinence or agree to use a condom during sexual 
contact with a pregnant female or a female of childbearing potential while participating in 
the study, during dose interruptions and for at least 28 days following study drug 
discontinuation, even if he has undergone a successful vasectomy
11. Ability to comply with all study-related procedures, medication use, and evaluations
12. Ability to understand and give written informed consent, and comply with the protocol
Subjects for whom at least one inclusion criterion is not fulfilled are considered screening
failures.
Sponsor: MorphoSys AG
Confidential
Page 46 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
8.2 Exclusion Criteria For All Subjects
1. Primary refractory MM
2. Previous treatment with cytotoxic chemotherapy or large-field radiotherapy or other 
myeloma-specific therapy within 28 days prior to first study treatment (radiation to a single 
site as concurrent therapy is allowed)
3. Treatment with a systemic investigational agent within 28 days prior to first study treatment.
4. Solitary plasmacytoma or plasma cell leukemia
5. Previous allogenic stem cell transplantation
6. Known or suspected hypersensitivity to the excipients contained in the study drug 
formulation
7. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart 
Association [NYHA] classes III-IV)
8. Prior therapy with other monoclonal antibodies targeting the CD38 antigen or prior therapy 
with other IgG monoclonal antibodies months within 3 months prior to first study treatment, 
or IgM monoclonal antibodies within 1 month prior to first study treatment.
9. Clinical or laboratory evidence of active hepatitis B (positive hepatitis B surface antigen 
[HBsAg] with negative hepatitis B surface antibody [HBsAb]) or hepatitis C (positive 
hepatitis C virus [HCV] antibody)
10. History of positive human immunodeficiency virus (HIV) test result (enzyme-linked 
immune-sorbent assay [ELISA] or Western blot)
11. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity 
grade 3 or higher (per National Cancer Institute [NCI] Common Terminology Criteria for 
Adverse Events [CTCAE], version 4.0)
12. Presence of diarrhea of grade 2 or higher (per NCI CTCAE, version 4.0)
13. Any active systemic infection
14. Any antibiotic therapy due to infections 2 weeks prior to first study drug administration
15. Current treatment with immunosuppressive agents other than prescribed corticosteroids (not 
more than 10 mg prednisone equivalent)
16. Major surgery < 4 weeks prior to first study drug administration or ongoing side effects of 
such surgery
17. Systemic diseases (cardiovascular, renal, hepatic, etc.) that would prevent study treatment
18. MM with central nervous system (CNS) involvement
19. Prior or concomitant malignancy (other than MM) except adequately treated basal cell or 
squamous cell carcinoma of the skin, carcinoma in situ of the cervix, prostate cancer not 
requiring treatment or other cancer for which the subject has been disease-free for at least 
3 years. For the combination therapy with lenalidomide or pomalidomide, this should be at 
least 5 years
Sponsor: MorphoSys AG
Confidential
Page 47 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
20. Pregnancy or breastfeeding in women and women of childbearing potential not using an 
acceptable method of birth control
21. History of non-compliance to medical regimens or subjects who are considered potentially 
unreliable and/or not cooperative
Subjects for whom at least one exclusion criterion is fulfilled are considered screening failures.
8.2.1 Additional Eligibility Criteria for Treatment With MOR03087 With/Without 
Dexamethasone
Inclusion Criteria
1. Documented diagnosis of MM; specifically, relapsed or refractory MM defined as:
• 
Failure of at least two previous therapies; previous therapies must include an 
immunomodulatory agent and a proteasome inhibitor (either together or as part of 
different therapies)
• 
All subj ects must have documented progression during or after their last prior therapy for 
MM
2. Creatinine clearance > 30 mL/min (calculated using the Cockcroft-Gault equation)
3. Platelets:
• 
> 80 x 109/L, without previous transfusion within the last 4 weeks before first study drug 
administration
• 
> 50 x 109/L (for dose levels >4 mg/kg with or without DEX). Subjects are not allowed 
to have received platelet transfusion within the last 4 weeks before study drug 
administration.
Exclusion Criteria
1. For subjects receiving DEX: Known or suspected hypersensitivity to DEX or any of the 
excipients
8.2.2 Additional 
Eligibility 
Criteria 
for 
the 
Treatment 
With 
MOR03087, 
Dexamethasone and Lenalidomide
Inclusion Criteria
1. Documented diagnosis of MM; specifically, relapsed or refractory MM defined as:
• 
Received at least one previous therapy
• 
All subj ects must have documented progression during or after their last prior therapy for 
MM
2. Ability to understand the reason for and understand the special conditions of the pregnancy 
prevention risk minimization plan and give written acknowledgement of these
Sponsor: MorphoSys AG
Confidential
Page 48 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
3. Ability and willingness to comply with the special conditions of the pregnancy prevention 
risk minimization plan
4. Creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault equation)
5. Platelets:
• 
> 75 x 109/L for 
cells
• 
> 30 x 109/L for 
cells.
Exclusion Criteria
1. Known or suspected hypersensitivity or intolerance to 
any of the excipients
During the treatment with LEN, the investigators need to 
prevention risk minimization plans (see Appendix 18.8.1).
8.2.3 Additional 
Eligibility 
Criteria 
for 
the 
Dexamethasone and Pomalidomide
Inclusion Criteria
1. Documented diagnosis of MM; specifically, relapsed and refractory MM defined as:
• 
Received at least two previous therapies including LEN and a proteasome inhibitor
• 
All subjects must have documented progression during or within 60 days after their last 
prior therapy for MM
2. Ability to understand the reason for and understand the special conditions of the pregnancy 
prevention risk minimization plan and give written acknowledgement of these
3. Ability and willingness to comply with the special conditions of the pregnancy prevention 
risk minimization plan
4. Creatinine clearance > 45 mL/min (calculated using the Cockcroft-Gault equation)
5. Platelets:
• 
> 75 x 109/L for 
cells
• 
> 30 x 109/L for 
cells
Exclusion Criteria
1. Known or suspected hypersensitivity to POM, LEN, thalidomide, DEX or to any of the 
excipients
subjects in whom < 50% of bone marrow nucleated cells are plasma 
subjects in whom > 50% of bone marrow nucleated cells are plasma
LEN, POM, thalidomide, DEX or to 
follow the corresponding Pregnancy
Treatment 
With 
MOR03087,
subjects in whom < 50% of bone marrow nucleated cells are plasma 
subjects in whom > 50% of bone marrow nucleated cells are plasma
Sponsor: MorphoSys AG
Confidential
Page 49 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
2. Subject who are refractory (defined as progression during or within 60 days after their last 
dose of POM) or intolerant to POM
During the treatment with POM, the investigators need to follow the corresponding Pregnancy 
prevention risk minimization plans (see Appendix 18.8.2).
8.3 Definition of Woman of Childbearing Potential
This protocol defines a female of childbearing potential as a sexually mature woman who:
• 
has not undergone a hysterectomy or bilateral oophorectomy or
• 
has not been naturally postmenopausal (amenorrhea following cancer therapy does not 
rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses 
at any time in the preceding 24 consecutive months).
8.4 Procedures for Enrollment
A full written informed consent must be available before the start of screening activities. In 
addition, for subjects who could potentially be assigned to the MOR03087 + LEN + DEX or 
MOR03087 + POM + DEX combination therapy parts, a pregnancy prevention information 
leaflet must also be available before assignment to these parts (see Appendix 18.8).
Enrolment will be performed at baseline after all inclusion and exclusion criteria have been 
checked and the subject is found to be eligible. Enrolment will be performed by means of an 
interactive web response system (IWRS) connected to the electronic data capture (EDC) system. 
The investigator will be informed about the enrolment via an e-mail or FAX.
Part A dose levels 1-7 will be tested sequentially, and only one dose level will be open for 
enrolment at any time. Starting with Part A dose level 8, Parts B and C will open in parallel (at 
dose level 6 [6b and 6c]). Following completion of dose level 7c (8.0 mg/kg MOR03087 + DEX) 
(and dose level 7b if the DMC recommends to open this cohort), Cohorts 7d and 7e may open in 
parallel with dose levels 8b (if the DMC recommends to open this cohort) and 8c. New cohorts 
will not start before the DMC returns a positive recommendation based on safety read-outs from 
prior cohorts as laid down in the DMC Charter.
8.5 Dose Limiting Toxicities
Adverse events will be graded according to NCI CTCAE, version 4.0, with a DLT being defined 
as an AE assessed as having a suspected or unknown relationship to the study drug (MOR03087, 
POM, or LEN) and meeting one of the following criteria: •
• 
Non-hematologic DLT: 
o 
Liver
Any grade 3 AST/ALT that does not resolve to grade 1 within 14 days or any 
grade 4 elevation in liver function tests (AST/ALT) 
o 
Gastrointestinal
> Grade 3 vomiting or nausea despite the use of standard antiemetics
Sponsor: MorphoSys AG
Confidential
Page 50 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
> Grade 3 diarrhea or constipation despite the use of optimal treatment 
o 
All other events
> Grade 3 (excluding hypersensitivity reactions and fatigue)
• 
Hematologic DLT:
o 
Grade 4 thrombocytopenia that requires more than one platelet transfusion and 
does not resolve to grade 2 or less within 14 days 
o 
Grade 4 neutropenia that does not resolve to grade 2 or less within 14 days 
o 
Or any other grade 4 hematologic toxicities that do not resolve to grade 2 or less 
within 14 days and that are considered clinically relevant by the investigator
• 
Any AE that delays treatment with study drug for more than 14 days
In addition, any event will only qualify as a DLT if a worsening of the event from baseline of at 
least 2 CTCAE Grades occurs.
The DLTs for the POM combination cohorts are specified as above except for the hematological 
DLTs which are as follows:
• 
Hematologic DLT:
o 
Grade 4 neutropenia for > 7 days
o 
Febrile neutropenia (ANC <1000/mm3 with a single temperature of >38.3°C or a 
sustained temperature of > 38°C for more than 1 hour) 
o 
Thrombocytopenia
- Platelet count < 25,000/pL that requires more than one platelet transfusion or
- Platelet count > 25,000/pL to < 50,000/pL with significant bleeding (defined as 
need for hospitalization and/or platelet transfusion)
o 
Or any other grade 4 hematologic toxicities that do not resolve to grade 2 or less 
within 14 days and that are considered clinically relevant by the investigator
The DLTs for the LEN combination cohorts are specified as above except for the hematological 
DLTs which are as follows:
• 
Hematologic DLT:
o 
Grade 4 neutropenia for > 7 days
o 
Febrile neutropenia (ANC <1000/mm3 with a single temperature of >38.3°C or a 
sustained temperature of > 38°C for more than 1 hour) 
o Thrombocytopenia
- Platelet count < 30,000/pL that requires more than one platelet transfusion or
- Platelet count > 30,000/pL to < 50,000/pL with significant bleeding (defined as 
need for hospitalization and/or platelet transfusion)
o 
Or any other grade 4 hematologic toxicities that do not resolve to grade 2 or less 
within 14 days and that are considered clinically relevant by the investigator
The DLT period covers Day 1 of cycle 1 (starting with first study drug administration) until 
Day 29 (before start of the second cycle). Granulocyte-colony stimulating factor (GCSF) therapy 
is prohibited during this time.
Laboratory DLTs will be reported as AEs.
Sponsor: MorphoSys AG
Confidential
Page 51 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Subjects experiencing DLTs in the study should not receive further study drug.
If upon treatment with POM or LEN, subjects present with protocol-defined DLTs or toxicities 
or conditions described in the corresponding Section 9.1.4, treatment must be modified or 
interrupted accordingly.
If upon treatment with DEX, subjects present with protocol-defined toxicities or conditions 
described in the corresponding SmPC, treatment must be modified or interrupted accordingly.
8.6 Other Reasons for Treatment Postponement
Study drug administration may be delayed for medical or other reasons (e.g., social reasons, 
weather circumstances). In case of a delay in study drug administration, the treatment should be 
restarted as early as possible. Should treatment be delayed for more than 14 days after the missed 
dose, then the treatment should be permanently discontinued. The subject should continue with 
the first follow-up visit in the study.
8.7 Withdrawal and Termination Criteria
8.7.1 
Subject Withdrawal
In accordance with the current version of the Declaration of Helsinki and the European 
Parliament and Council Directive 2001/20/EC in its current version, each subject is free to 
withdraw from the study at any time without giving any reason for his or her decision. 
Investigators also have the right to withdraw subjects from the study in the event of illness, AEs, 
or other reasons concerning the health or well-being of the subject, or in the case of lack of 
cooperation and/or protocol non-compliance.
Should the investigator decide to discontinue Investigational Medicinal Product (IMP) 
administration for a specific subject during the treatment period in the event of illness, AEs, or 
other reasons concerning the health or well-being of the subject, then the subject will be allowed 
to complete the follow-up visits in accordance with the protocol.
Should a subject decide to withdraw after administration of the IMP, or should the investigators 
decide to withdraw the subj ect, all efforts should be made to complete and report the observations 
up to the time of withdrawal as thoroughly as possible. A complete final evaluation at the time 
of the subject’s withdrawal (End of Study visit) should be made.
During the conduct of the study, the sponsor will also review the safety data for trends and signals 
that would indicate the need for withdrawal of a subject or subjects.
If available, the reason for withdrawal should be noted in the electronic Case Report Form 
(eCRF). If the reason for withdrawal is an AE, monitoring will continue until the outcome is 
evident (provided that the reason for withdrawal is not “withdraw consent”). The specific event 
or test result(s) must be recorded in the eCRF.
Subjects may withdraw or may be withdrawn from the study for the following reasons:
Sponsor: MorphoSys AG
Confidential
Page 52 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
A subject is significantly non-compliant with the requirements of the protocol (e.g., a subject 
who takes prohibited concomitant medications for a consistent period that, in the 
investigator’s opinion, would interfere with the interpretation of the study data).
• 
A subject becomes pregnant.
• 
A subj ect has an AE that would, in the investigator’s judgment, make continued participation 
in the study an unacceptable risk.
• 
The sponsor decides to discontinue the study.
• 
A subject withdraws at his or her own request (withdrawal of consent).
• 
A subject has major protocol violations.
• 
A subject is withdrawn at the specific request of the sponsor in case of serious safety 
concerns.
• 
A subject is treated with another monoclonal antibody.
• 
A subject requires different myeloma-specific treatment due to progressive disease.
Subjects who receive specific anti-myeloma treatment other than those specified in the protocol 
should be withdrawn from the study.
Subjects who withdraw whilst their safety assessment period is not evaluable will only be 
replaced during the dose-escalation phase until the applicable cohort consists of a sufficient 
number of evaluable subjects. However, withdrawals due to DLTs will not be replaced.
8.7.2 
Study or Site Termination
There are no formal termination criteria for this study. The sponsor reserves the right to terminate 
the study at any time. The investigator reserves the right to terminate conduct of the study at 
his/her site at any time. Also, the DMC can recommend termination of the study at any time for 
reasonable safety reasons. Should this be necessary, the procedures will be arranged on an 
individual study basis after review and consultation by all involved parties. In terminating the 
study, the sponsor and the investigator will ensure that adequate consideration is given to the 
protection of the subjects’ interests. Independent Ethics Committees (IECs) and Competent 
Authorities will be notified of premature termination in accordance with applicable regulatory 
requirements.
9 TREATMENT OF SUBJECTS
Each investigator is responsible for ensuring that deliveries of IMP and other study materials 
from the sponsor are correctly received, recorded, handled, and stored safely and properly in 
accordance with all applicable regulatory guidelines, and used in accordance with this protocol. 
The investigator can delegate these tasks to a dedicated pharmacist or another person (according 
to the national laws and regulations). Drug accountability forms will be kept by the site during 
the study and will be checked during monitoring visits.
All IMP containers (opened, unopened, or empty) must be returned to the sponsor/sponsor’s 
designee and will be destroyed by the sponsor or representative after the study and overall drug 
accountability have been completed by the sponsor or representative. A list of IMP and other
Sponsor: MorphoSys AG
Confidential
Page 53 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
materials that have been returned, or destroyed, must be prepared and signed by the principal 
investigator or designee. If there are any discrepancies, an explanation for these should also be 
provided.
The IB for MOR03087, SmPCs for DEX (sample), LEN, and POM, will be supplied to the sites.
9.1 Investigational Medicinal Products
9.1.1 
MOR03087
Laboratory Evaluations prior to each Administration of MOR03087
For all administrations of MOR03087, the following parameters should be taken pre-dose on the 
day of study drug administration and, if outside the limits described below, administration of 
MOR03087 should be postponed (see Section 8.6):
Value
Subject should not be dosed with MOR03087 if the value is:
Creatinine
> 3 x ULN
Hemoglobin
< 8.0 g/dL (subject should be transfused before dosing)
Platelets
< 25.0 x 109/L (< 30.0 x 109/L in the LEN and POM parts)
WBC
< 1.0 x 109/L
Potassium
> 6.0 mmol/L
Sodium
> 155 mmol/L
AST/ALT
> 3 x ULN
POM, LEN or DEX might have to be interrupted and/or dose reduced as well according to 
Section 9.1.4.
MOR03087 is a fully human monoclonal antibody targeting the CD38 membrane protein. It is 
presented as a clear to slightly opalescent, slightly yellowish sterile solution for injection 
formulated in a histidine buffer at pH 6.8, with sodium chloride (NaCl) and Tween20. 
MOR03087 will be provided in a labelled 10R glass vial at a concentration of 8-12 mg/mL with 
an extractable volume of 5 mL (40 mg/vial-60 mg/vial). The appropriate number of vials will be 
supplied to each respective site. Four vials will be packed in 1 drug box. MOR03087 must be 
stored at -20°C ± 5°C. The drug has to be obtained from the freezer between 3 days to 16 hours 
before the planned start of the infusion to allow for the preparation of the infusion. The drug has 
to be thawed as well as stored at 2-8°C until the preparation for infusion. MOR03087 will be 
diluted in 100 mL or 250 mL as appropriate with commercially available 0.9% NaCl saline 
(Ecoflac® plus from B. Braun) for injection and will be provided by the sponsor.
The individual MOR03087 infusion will be prepared at the site, according to directions of the 
sponsor, which will be laid down in a drug preparation manual. It will be administered by slow 
intravenous (IV) infusion over approximately 2 hours. If any given infusion is well tolerated and 
could be administered without any infusion reaction, the subsequent infusion should be 
administered with the next shortest infusion duration according to the following steps: 90 min.,
Sponsor: MorphoSys AG
Confidential
Page 54 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
60 min., 45 min., 30 min. (scheme in Table 3). Infusion duration should not be shorter than 
30 minutes.
Should infusion reactions appear at infusion durations shorter than 2 hours, the subsequent 
infusion duration should be at least one step higher, i.e., the next longest infusion duration. Only 
one further series of reductions to shorter infusion durations will then be allowed when at least 
two consecutive infusions have been well tolerated without infusion reactions (Figure 3).
Any grade 3 or 4 infusion-related reactions should lead to discontinuation of the subject, and 
infusion-related reactions should be managed as outlined in Section 9.1.3.
In exceptional cases -  and after discussion between the investigator and the sponsor -  the 
investigator may determine that it is in the best interest of the subject not to change the duration 
of the infusion following this scheme but to continue to use a 2 hour infusion duration, in which 
case the sponsor should be informed accordingly.
Table 3 
Scheme for Shortening of Infusion Duration
Level
Infusion Duration
5
120 min.
4
90 min.
3
60 min.
2
45 min.
1
30 min.
Sponsor: MorphoSys AG
Confidential
Page 55 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Figure 3 
Flow-chart for the Shortening of Infusion Duration
In the first cohort only, the infusion of MOR03087 will be preceded by a 1-hour infusion of 
50 mL 5% human albumin (Alburex®; CSL Behringer), to saturate the infusion line with protein 
in order to block binding of the antibody to the plastic infusion line. This aims to optimize the 
amount of antibody delivered at such a low dose as that given in Part A/ escalation dose 1.
9.1.2 Drugs Used in Combination with MOR03087
9.1.2.1 
Lenalidomide
Lenalidomide (Revlimid®) will be supplied by the sponsor. LEN capsules for oral administration 
are commercially available in multiple dosage strengths containing LEN (5 mg, 10 mg, 15 mg, 
and 25 mg) and conventional solid oral dosage excipients. The appropriate strength will be 
supplied to the subject. LEN should be stored as directed on the label.
Lenalidomide must be handled per special warnings and precautions for use as specified in the 
SmPC for Revlimid®.
9.1.2.2 Pomalidomide
Pomalidomide (Imnovid®) will be supplied by the sponsor. POM (Imnovid®) capsules for oral 
administration are commercially available in multiple dosage strengths containing POM (1 mg,
Sponsor: MorphoSys AG
Confidential
Page 56 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
2 mg, 3 mg and 4 mg) and conventional solid oral dosage excipients. The appropriate strength 
will be supplied to the subject. POM should be stored as directed on the label.
Pomalidomide must be handled per special warnings and precautions for use as specified in the 
SmPC for Imnovid®.
9.1.2.3 Dexamethasone
DEX tablets containing 8.0 mg dexamethasone for oral administration will be provided by the 
sponsor from a commercial source. DEX should be stored as directed on the label.
9.1.3 Premedication and Management of Infusion Reactions
During Cycle 1, all subjects should be given premedication, including an antipyretic 
(e.g., paracetamol), and a histamine H1 receptor blocker according to the local standard of care. 
In medically justified cases, the investigator may use other medications (e.g., steroids for the 
non-DEX-cohorts as per local standard but not exceeding 10 mg prednisolone equivalent), doses 
and/or formulations if this is documented thoroughly in the eCRF and the source data. If the 
subject did not have any infusion reaction during Cycle 1, then premedication can be stopped at 
the discretion of the investigator for subsequent treatment cycles. Otherwise, the premedication 
should be continued for subsequent administrations of MOR03087 as well.
G rade 1 or 2 infusion reactions
If a subject presents with grade 1 or grade 2 infusion reactions:
• 
Infusion should be stopped.
• 
Subject should receive appropriate treatment with an H1 antihistamine and/or
paracetamol or prednisolone.
• 
Once symptoms are resolved, the infusion can be continued at an infusion rate of 50% of 
the initial rate until the complete dose is administered.
G rade 3 or 4  infusion reactions
If a subject presents with grade 3 or grade 4 infusion reactions:
• 
Infusion should be discontinued immediately.
• 
Subject should receive appropriate treatment with an H1 antihistamine and/or
paracetamol or prednisolone as clinically indicated and, if necessary, further medications 
(i.e., epinephrine, bronchodilator).
• 
Subject should not receive further study drug.
9.1.4 
Dose Reductions and Modifications for POM, LEN and DEX
If the treatment has been interrupted and the next cycle is delayed beyond 29 days after Day 1
of the prior cycle, then Day 1 of the next cycle will be defined as the first day that the treatment
is resumed.
Sponsor: MorphoSys AG
Confidential
Page 57 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
9.1.4.1 LEN Dose Modification
Subjects will be evaluated for AEs at each visit with the NCI CTCAE version 4.0 as a guide for 
the grading. Interruptions and reductions are permitted throughout the study.
Table 4 outlines the dose reduction steps for LEN. Instructions for dose interruptions and 
reductions for LEN are outlined in Table 5.
Table 4 
Lenalidomide Dose Reduction Steps by Dose Level
Dose Levels
LEN Dose Reduction 
(Days 1 -  21 of Every 28-Day Cycle)
Starting Dose
25 mg
Dose Level -1
15 mg
Dose Level -2
10 mg
Dose Level -3
5 mg
LEN: lenalidomide
Table 5 
LEN Dose Modification Instructions for Toxicities
Toxicity
LEN Dose Modification
Neutropenia (ANC < 0.5 x 109/L)
Stop LEN dosing and follow hematology weekly. If 
the subject was not receiving GCSF therapy, GCSF 
therapy may be started at the discretion of the 
treating physician. When ANC returns to 
> 0.5 x109/L, LEN dosing may be restarted at same 
dose level if neutropenia was the only DLT and 
GCSF treatments are continued, or decreased by 
one dose level.
Note: GCSF is prohibited during Cycle 1
Thrombocytopenia (Platelets <30 x109/L)
Stop LEN dosing and follow hematology weekly. 
When platelets return to > 30 x109/L, resume LEN 
dosing at one dose level lower
Sponsor: MorphoSys AG
Confidential
Page 58 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Toxicity
LEN Dose Modification
Rash
Grade 2-3 skin rash: LEN interruption or 
discontinuation should be considered at the 
discretion of the treating physician.
Angioedema, Grade 4 rash, exfoliative or bullous 
rash or if Stevens-Johnson syndrome (SJS) or toxic 
epidermal necrolysis is suspected, LEN must be 
discontinued permanently
Other > Grade 3 LEN-related adverse events
Stop LEN dosing and restart at one dose level 
lower when toxicity has resolved to < Grade 2 at 
physician’s discretion.
ANC: absolute neutrophil count; DLT: dose limiting toxicity; GCSF: granulocyte colony-stimulating factor; LEN: 
lenalidomide
LEN should be discontinued if the subject is unable to tolerate the lowest dose level. At the 
discretion of the investigator, the treatment with MOR03087 and dexamethasone may be 
continued.
9.1.4.2 POM Dose Modification
Subjects will be evaluated for AEs at each visit with the NCI CTCAE version 4.0 as a guide for 
the grading. Interruptions and reductions are permitted throughout the study.
Table 6 outlines the dose reduction steps for POM. Instructions for dose interruptions and 
reductions for POM are outlined in Table 7 (hematologic and non-hematologic toxicities).
Table 6 
Pomalidomide Dose Reduction Steps by Dose Level
Dose Level (Days 1-21 of 28 days)
POM Dose Reduction 
(Days 1-21 of Every 28-Day Cycle)
Starting dose
4 mg
Dose Level -1
3 mg
Dose Level -2
2 mg
Dose Level -3
1 mg1
POM: pomalidomide
1 The POM treatment regimen should be discontinued if the subject cannot tolerate the 1 mg dose.
Sponsor: MorphoSys AG
Confidential
Page 59 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Table 7 
Pomalidomide Dose Modification Instructions for Toxicities
Toxicity
POM Dose Modification
Neutropenia ANC < 0.5 x 109/L) or
Febrile neutropenia (fever > 38.5 °C and ANC 
< 1.0 x 109/L)
Hold POM dosing and follow hematology weekly. If 
the subject was not receiving GCSF therapy, GCSF 
therapy may be started at the discretion of the treating 
physician. When ANC returns to > 0.5 x 109/L, restart 
POM dosing at one dose level lower.
Note: GCSF is prohibited during Cycle 1
Thrombocytopenia (Platelets < 25 x 109/L)
Hold POM dosing and follow hematology weekly. 
POM dosing may resume at one dose level lower once 
the platelet count has recovered to > 50,000/pL.
Other > Grade 3 POM-related toxicities
Interrupt POM dosing and restart at one dose level 
lower when toxicity has resolved to < Grade 2 at the 
physician’s discretion
ANC: absolute neutrophil count; GCSF: granulocyte colony-stimulating factor; POM: pomalidomide
To initiate a new cycle of POM, the neutrophil count must be > 0.5 x 109/L with or without 
GCSF, the platelet count must be > 50 x 109/L.
POM should be discontinued if subject is unable to tolerate the lowest dose level. At the 
discretion of the investigator, the treatment with MOR03087 and dexamethasone may be 
continued.
9.1.4.3 DEX Dose Modifications
Table 8 and Table 9 outline the dose reduction steps for DEX, and instructions for dose 
interruptions and reductions can be found in Table 10.
Table 8 
DEX Dose Reduction Steps (Less Than or Equal to 75 Years Old)
Dose Level
DEX Dose (Days 1, 8, 15, 22 of 28 days)
Starting Dose
40 mg
Dose Level -1
20 mg
Dose Level -2
10 mg1
1 DEX should be discontinued if subject is unable to tolerate 10 mg dose. Subjects may continue on single agent 
POM or LEN until disease progression.
Table 9 
DEX Dose Reduction Steps (More Than 75 years Old)
Dose Level
DEX Dose (Days 1, 8, 15, 22 of 28 days)
Starting Dose
20 mg
Dose Level -1
12 mg
Dose Level -2
8 mg1
1 DEX should be discontinued if subject is unable to tolerate 8 mg dose. Subjects may continue on single agent 
POM or LEN until disease progression.
Sponsor: MorphoSys AG
Confidential
Page 60 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Table 10 
Dose Reductions for Dexamethasone Related Toxicities
Toxicity
DEX Dose Modification
Dyspepsia = Grade 1-2
Maintain dose and treat with histamine (H2) 
blockers or equivalent. Decrease by one dose level 
if symptoms persist.
Dyspepsia > Grade 3
Hold dose until symptoms are controlled. Add 
histamine (H2) blocker or equivalent and decrease 
one dose level when dose is restarted.
Edema > Grade 3
Use diuretics as needed and decrease dose by one 
dose level.
Confusion or mood alteration > Grade 2
Hold dose until symptoms resolve. When dose is 
restarted decrease dose by one dose level.
Muscle weakness (steroid myopathy) > Grade 2
Hold dose until muscle weakness < Grade 1. When 
dose is restarted decrease dose by one dose level.
Hyperglycemia > Grade 3
Decrease dose by one dose level. Treat with insulin 
or oral hypoglycemic agents as needed.
Acute pancreatitis
Discontinue subject from DEX treatment regimen.
Other > Grade 3 dexamethasone-related adverse 
events
Stop DEX dosing until the adverse event resolves 
to < Grade 2. Decrease by one dose level when 
DEX dosing is resumed.
DEX: dexamethasone
If recovery from toxicities is prolonged beyond 14 days, then the dose of DEX will be decreased by one dose 
level.
9.2 Method of Numbering Subjects and Assigning Subjects to Treatment 
Groups
Part A dose levels 1-7 will be tested sequentially and only one dose level will be open for 
enrolment at any time. Starting with Part A dose level 8, Parts B and C will open in parallel (at 
dose level 6 [6b and 6c]). Following completion of dose level 7c (8.0 mg/kg MOR03087 + DEX) 
(and dose level 7b if the DMC recommends to open this cohort), Cohorts 7d and 7e may open in 
parallel with dose levels 8b (if the DMC recommends to open this cohort) and 8c (see 
Section 7.1, Figure 1). New cohorts will not start before the DMC returns a positive 
recommendation based on safety read-outs from prior cohorts as laid down in the DMC Charter.
The allocation to a cohort will be technically managed by the IWRS system based on an external 
algorithm starting from cohorts 7c and 8.
For each subject screened, the investigator or designee will log into the IWRS system and will 
enter the month and year of birth and the gender. The IWRS will allocate the next available 
screening identification (ID) number, ensuring that screening ID numbers are assigned 
sequentially per site. The screening ID number will be a 5-digit number with the first 2 digits 
identifying the site (10, 11, ...) and the last 3 digits identifying the sequence number assigned
Sponsor: MorphoSys AG
Confidential
Page 61 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
by the IWRS (001, 002, ...) for each site continuously. For sites located in Germany, the site 
number will start with 1 or 2, and for sites located in Austria with 3. Leading zeros will be used 
for the second part of the ID number to ensure a consistent length of 5 digits. The third subject 
screened at site 14 in Germany would, for example, be identified as 14003. The fourth subject 
screened at site 14 in Germany would, for example, be identified as 14004.
The investigator will enter the information (i.e., gender, month and year of birth and the 
associated screening ID number) into the confidential subject identification list.
If the subject qualifies, enrolment will be done centrally at baseline, again employing the IWRS. 
The part and dose level assignment has to be triggered via IWRS between 3 days and at least 
16 hours before the planned administration of MOR03087. The fact that a subject has been 
enrolled will be reported immediately and automatically by the system to the dedicated 
pharmacist (if applicable), the investigator, the Clinical Research Organization (CRO), and the 
sponsor. The IWRS report will contain the information on the respective part/dose level the 
subject is enrolled to.
The IWRS will only allow enrolment to the next cohort with a higher dosing regimen in the 
respective study arm after that cohort has been actively opened in the IWRS system for enrolment 
following DMC review.
The subject will be identified by the previously assigned screening ID number throughout the 
study. No additional subject or randomization number will be used.
A subject enrolled in the study is not permitted to re-enroll for a second course of study 
participation.
Subjects who are considered screening failures may be re-screened again only once. In this case, 
the subjects will receive a new subject number. The period between both screening visits needs 
to be at least 6 weeks.
9.3 Blinding
Blinding at the level of study treatment does not apply since the study will be open label.
9.4 Prior and Concomitant Therapy
Any prior, concomitant, or procedural medications or therapy given to or taken by the subject 
within 1 month before and up to the end of the study will be recorded in the eCRF along with 
the indication and dosage. However, information should be provided on any previous 
myeloma-specific therapies since the time point of the first diagnosis of MM. This information 
should include start and end of administration, best response achieved using respective 
medication(s) with corresponding date and diagnosis of disease progression (date and type) using 
respective medication(s). The generic or the trade name may be recorded. Other than the IMP, 
subjects should not receive any other myeloma-specific therapy during the study.
Non-investigational medications needed to treat concomitant medical conditions may be 
continued during the study. Any other medication for treatment of symptoms of MM or 
concurrent diseases is allowed and can be prescribed at the discretion of the investigator.
Sponsor: MorphoSys AG
Confidential
Page 62 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
However, the medical monitor should be contacted to discuss the use of any myeloma-related 
therapies before those therapies are started.
Subjects will continue to receive packed red blood cell (RBC) as clinically indicated. Information 
regarding transfusions during the study will be recorded in the eCRF.
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM parts of 
the study is mandatory. Low-dose aspirin, low molecular weight heparin, or other equivalent 
antithrombotic or anti-coagulant will be given during the study to all subjects assigned to receive 
POM or LEN. As of Day 29 (Cycle 2), GCSF therapy can be given at the discretion of the 
investigator, if clinically indicated.
However, treatments that might potentially interfere with the IMPs should be avoided and, with 
the exception of treatments required in emergency situations, these should be approved by the 
medical monitor prior to administration.
The investigator should instruct the subject not to take any additional medications (including 
over-the-counter-products) during the study without prior consultation. All medications 
(including over-the-counter medications) administered after the subject has signed the informed 
consent must be listed on the concomitant medications form in the eCRF.
All respective treatments, including for example transfusions, should be recorded in the eCRF 
as concomitant medication.
9.5 Treatment Compliance
LEN, POM and DEX will be taken orally either under the supervision of the investigator or at 
home.
Subjects will be provided with the appropriate number of POM or LEN capsules and DEX 
tablets.
Drug accountability will be noted by the field monitor during site visits and at the completion of 
the study. On all other occasions, the subject will take LEN or POM capsules and DEX tablets 
as directed by the investigator at home. Compliance will be confirmed by the accounting of used 
and unused medication, which will be recorded in the eCRF.
10 STUDY PROCEDURES
All efficacy and safety measurements obtained during the course of the study are summarized in 
the study flow charts and schedule of assessments (see Section 7.1).
All subjects must satisfy all of the inclusion criteria and none of the exclusion criteria listed in 
Sections 8.1 and 8.2. Signed and dated informed consent must be obtained from all subjects prior 
to their entering the study.
Sponsor: MorphoSys AG
Confidential
Page 63 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
10.1 Dose Escalation Parts A - E (Bi-Weekly or Weekly MOR03087 With or 
Without DEX, Weekly with POM+DEX, Weekly with LEN+DEX) and 
Confirmation Cohorts
10.1.1 Screening (< 4 Weeks before Day 1)
The following will be obtained or performed at screening:
• 
Informed consent
• 
Obtain screening ID from IWRS
• 
Medical history, including disease staging based on Durie-Salmon and International 
Staging System (ISS) criteria (Durie 1975; Greipp 2005) and documentation of 
immunoglobulin type; in addition, in subjects assigned to receive POM or LEN, all prior 
venous thrombotic events (VTE) and pulmonary embolisms that occurred will be 
collected
• 
Demography
• 
Inclusion/exclusion criteria
• 
Karnofsky performance status
• 
Blood 
samples 
for 
evaluation 
of hematology, 
serum 
chemistry 
(including 
B2-microglobulin), coagulation, beta human chorionic gonadotropin (PHCG) pregnancy 
test for women of childbearing potential (to be performed within 10-14 days prior to 
the start of treatment in study cohorts that include LEN or POM), endocrinology, 
anti-MOR03087 antibodies, B, T, and NK cells including CD16 expression, serum 
M-protein, serum free light chains (FLCs), serology (hepatitis B and C), and flow 
cytometry of peripheral MM cells
• 
Urine sample for urinalysis
• 
Sample from 24-hour urine for evaluation of urine M-protein. It is accepted that the 
pre-collected 24-hour urine sample which MM subjects bring to the hospital for every 
routine visit within the scope of usual standard of care procedure is used for the screening 
analysis.
• 
Bone marrow biopsy sample for histology, immunophenotyping (CD38 expression on 
MM cells), cytogenetics of MM cells (if no historical data are available), and biomarker 
storage sample (results from bone marrow examination done within 28 days prior to first 
dose are acceptable, if the subject has been hematologically stable since then)
• 
Bone skeletal survey by x-ray, CT, or MRI imaging (where medically indicated, as a 
regular assessment of standard of care in subjects with relapsed or refractory MM)
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination) •
• 
Ocular examination by an ophthalmologist (including distance visual acuity, optical 
coherence tomography [if available], and ophthalmoscopy under full mydriasis [if optical 
coherence tomography is unavailable])
Sponsor: MorphoSys AG
Confidential
Page 64 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Body weight and height
• 
12-Lead electrocardiogram (ECG)
• 
Vital signs (blood pressure, pulse rate, respiratory rate, body temperature)
• 
Prior and concomitant medications, including history of previous myeloma-specific 
therapies and best response and type of disease progression for each previous MM 
treatment line
For subjects receiving weekly treatment, the additional following will be obtained,
performed, or assessed:
• 
All subjects (females as well as males) enrolled in the LEN and POM parts will receive 
an educational leaflet appropriate to their treatment, and will receive Pregnancy 
Counselling (see Section 12.2 and Appendix 18.8.1.3 / 18.8.2.3).
• 
Clinical review of sign/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms.
10.1.2 Cycle 1: Day 1
The inclusion/exclusion criteria should be reviewed prior to study drug administration on Day 1. 
Eligibility is based on screening and pre-dose day 1 laboratory values. If the subject is eligible, 
drug release via IWRS has to be triggered between 3 days to 16 hours before the planned start 
of MOR03087 infusion. The MOR03087 vial(s) have to be obtained from the freezer 3 days to 
16 hours, thawed at 2-8°C, and stored at 2-8°C before the planned start of study drug 
administration.
For women of childbearing potential in study cohorts that include LEN or POM, a 
pregnancy test (serum or urine) is to be performed within 24 hours prior to the start of 
treatment (see Section 12.2 and Appendix 18.8.1.3 / 18.8.2.3).
On Day 1, the following will be obtained, performed, or assessed prior to study drug 
administration:
• 
Inclusion/exclusion criteria
• 
Toxicity/AE assessment since last visit
• 
Concomitant medications
• 
Karnofsky performance status
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration), hematology, serum chemistry, predose pharmacokinetics 
(MOR03087 +/- LEN or POM), cytokines, serum M-Protein and serum FLC 
assessments.
Sponsor: MorphoSys AG
Confidential
Page 65 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Sample from 24-hour urine for M-Protein
• 
Urine sample for urinalysis, and urine pregnancy test for women of childbearing potential
• 
Mucosal cheek swab for DNA analysis of FcyRIIIa polymorphism
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Body weight
• 
Quality of life questionnaires (QLQ-MY20 and QLQ-C30)
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature 
immediately before infusion)
• 
Premedication
For subjects receiving weekly treatment, the additional following will be obtained,
performed, or assessed:
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
For subjects treated with LEN, 12-lead ECG may be performed at the investigator’s 
discretion
Study drug administration:
• 
MOR03087 Study drug administration (2-hour infusion)
• 
DEX, POM, LEN administration according to cohort assignment; time point for oral 
application of POM or LEN at start of MOR03087 infusion (+/- 5min). DEX should be 
given up to 3 hours prior to MOR03087 infusion start.
The following will be obtained, performed, or assessed after start of study drug administration:
• 
Blood samples for MOR03087 pharmacokinetics at 1, 2, 4, 8, and optional at 14 ± 2 (if 
on Day 1) hours after start of first infusion •
• 
According to cohort assignment blood samples for POM or LEN pharmacokinetics at 
1, 2 and 8 hours after start of first infusion
• 
Blood sample for “emergency laboratory” (except AST and ALT) for immediate 
evaluation and cytokines both 2 hours after end of infusion
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 2 and 
4 hours after end of infusion
Sponsor: MorphoSys AG
Confidential
Page 66 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Ongoing toxicity/AE assessment during the visit
10.1.3 Cycle 1: Day 2
On Day 2, the following will be obtained, performed, or assessed:
• 
Blood sample for hematology and serum chemistry
• 
Blood samples for MOR03087 pharmacokinetics at 14 ± 2 (if not taken on day 1) 
(optional), 22 ± 2, and 28 ± 2 hours after start of first infusion
• 
According to cohort assignment blood samples for POM or LEN pharmacokinetics at 
22 ± 2 hours after start of first infusion
• 
12-Lead ECG
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
Vital signs (pulse rate, blood pressure, respiratory rate, and body temperature)
• 
Toxicity/AE assessment
• 
Concomitant medication
For subjects receiving weekly treatment, study drug administration:
• 
POM, LEN administration according to cohort assignment; POM and LEN will be 
administered daily on Days 1-21 of each 28-day cycle.
At least 48 hours will pass between the first study drug administrations to the subjects of a cohort 
in order to observe for AEs. This provision will be waived for subjects in cohorts 6b/6c - 8b/8c 
as well as 7d/7e and 8d/8e.
After the first administration of study drug, the subjects will remain at the site until the end of 
Day 2 for safety monitoring.
10.1.4 Cycle 1: Day 4
The MOR03087 vial(s) have to be obtained from the freezer 3 days to 16 hours before planned 
start of study drug administration. The vials have to be thawed and stored at 2-8°C until 
preparation for administration.
On Day 4, the following will be obtained, performed, or assessed prior to study drug 
administration:
• 
Toxicity/AE assessment since the last visit
• 
Concomitant medications
Sponsor: MorphoSys AG
Confidential
Page 67 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration), hematology, serum chemistry, and predose pharmacokinetics 
(MOR03087)
• 
Body weight
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
• 
Premedication
For subjects receiving weekly treatment, the additional following will be obtained, performed,
or assessed:
• 
For subjects treated with LEN, 12-lead ECG may be performed at the investigator’s 
discretion
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
Study drug administration
• 
MOR03087 Study drug administration.
• 
POM, LEN administration according to cohort assignment; POM and LEN will be 
administered daily on Days 1-21 of each 28-day cycle; time point for oral application of 
POM or LEN at start of MOR03087 infusion (+/- 5min)
The following will be obtained, performed, or assessed after start of study drug administration:
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 2 and 
4 hours after end of infusion
• 
Blood sample for MOR03087 pharmacokinetics (after completion of infusion)
• 
Ongoing toxicity/AE assessment during the visit
10.1.5 Cycle 1: Day 8
On Day 8, the following will be obtained, performed, or assessed (for weekly treatment prior to 
study drug administration):
• 
Toxicity/AE assessment since last visit
• 
Concomitant medications
• 
Blood sample for hematology and serum chemistry
Sponsor: MorphoSys AG
Confidential
Page 68 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
For subjects receiving weekly treatment, the additional following will be obtained, performed,
or assessed prior to study drug administration:
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
For women of childbearing potential in study cohorts that include LEN or POM, a 
pregnancy test (serum or urine) is to be performed.
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration), for predose pharmacokinetics (MOR03087, +/-DEX, 
+/- POM / LEN) and for B, T, and NK cells
• 
Body weight
• 
12-Lead ECG (for subjects treated with LEN this assessment is at the investigator’s 
discretion)
• 
Premedication
For subjects receiving weekly treatment, study drug administration:
• 
MOR03087 Study drug administration
• 
DEX, POM, LEN administration according to cohort assignment; POM and LEN will be 
administered daily on Days 1-21 of each 28-day cycle; time point for oral application of 
POM or LEN at start of MOR03087 infusion (+/- 5min). DEX should be given up to 3 
hours prior to MOR03087 infusion start.
The following will be obtained, performed, or assessed after start of study drug administration:
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 2 and 
4 hours after end of infusion
• 
Ongoing toxicity/AE assessment during the visit
• 
Blood sample for MOR03087 pharmacokinetics (after completion of infusion)
• 
According to cohort assignment, blood samples for POM or LEN pharmacokinetics (after 
completion of infusion)
Sponsor: MorphoSys AG
Confidential
Page 69 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
10.1.6 Cycle 1: Day 15
The MOR03087 vial(s) have to be obtained from the freezer 3 days to 16 hours before planned 
start of study drug administration. The vials have to be thawed and stored at 2-8°C until 
preparation for administration.
On Day 15, the following will be obtained, performed, or assessed prior to study drug 
administration:
• 
Toxicity/AE assessment since the last visit
• 
Concomitant medications
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration), hematology, serum chemistry, anti-MOR03087 antibodies, 
and predose pharmacokinetics (MOR03087), serum M-Protein and serum FLC 
assessments.
• 
Sample from 24-hour urine for M-Protein
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Body weight
• 
Quality of life questionnaires (QLQ-MY20 and QLQ-C30)
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
• 
Premedication
For subjects receiving weekly treatment, the additional following will be obtained, performed, 
or assessed prior to study drug administration: •
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
For subjects treated with LEN, 12-lead ECG may be performed at the investigator’s 
discretion
• 
For women of childbearing potential in study cohorts that include LEN or POM, a 
pregnancy test (serum or urine) is to be performed
Study drug administration:
• 
MOR03087 Study drug administration
• 
DEX, POM, LEN administration according to cohort assignment; POM and LEN will be 
administered daily on Days 1-21 of each 28-day cycle; time point for oral application of
Sponsor: MorphoSys AG
Confidential
Page 70 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
POM or LEN at start of MOR03087 infusion (+/- 5min). DEX should be given up to 3 
hours prior to MOR03087 infusion start.
The following will be obtained, performed, or assessed after start of study drug administration:
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 2 and 
4 hours after end of infusion
• 
Blood sample for MOR03087 pharmacokinetics (after completion of infusion)
• 
Ongoing toxicity/AE assessment during the visit
10.1.7 Cycle 1: Day 22
On Day 22, the following will be obtained, performed, or assessed (for weekly treatment prior 
to study drug administration):
• 
Toxicity/AE assessment since last visit
• 
Concomitant medications
• 
Blood sample for hematology and serum chemistry
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
For subjects receiving weekly treatment, the additional following will be obtained, performed, 
or assessed prior to study drug administration: •
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration) and for predose pharmacokinetics (MOR03087)
• 
12-Lead ECG (for subjects treated with LEN this assessment is at the investigator’s 
discretion)
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
For women of childbearing potential in study cohorts that include LEN or POM, a 
pregnancy test (serum or urine) is to be performed within 24 hours prior to the start of 
treatment
• 
Body weight
• 
Premedication
Sponsor: MorphoSys AG
Confidential
Page 71 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
For subjects receiving weekly treatment, study drug administration:
• 
MOR03087 Study drug administration
• 
DEX administration according to cohort assignment. DEX should be given up to 3 hours 
prior to MOR03087 infusion start.
For subjects receiving weekly treatment, the following will be obtained, performed, or assessed 
after start of study drug administration:
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 2 and 
4 hours after end of infusion
• 
Blood sample for MOR03087 pharmacokinetics (after completion of infusion)
• 
Ongoing toxicity/AE assessment during the visit
10.1.8 Day 29 Visit (C2D1)
The MOR03087 vial(s) have to be obtained from the freezer 3 days to 16 hours before planned 
start of study drug administration. The vials have to be thawed and stored at 2-8°C until 
preparation for administration.
The following will be obtained, performed, or assessed prior to study drug administration:
• 
Toxicity/AE assessment since the last visit
• 
Concomitant medication
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration), hematology, serum chemistry, coagulation, B, T, and NK 
cells including CD16 expression, flow cytometry of peripheral MM cells, and predose 
pharmacokinetics (MOR03087), serum M-Protein and serum FLC assessments.
• 
Sample from 24-hour urine for M-Protein
• 
Urine sample for urinalysis and urine pregnancy test for women of childbearing potential
• 
Body weight
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Premedication (at the investigator’s discretion if no infusion reaction during Cycle 1)
For subjects who signed specific consent for additional bone marrow aspiration
• 
Bone marrow aspirate and biopsy: histology, immunophenotyping of MM cells (CD38 
expression on MM cells)
Sponsor: MorphoSys AG
Confidential
Page 72 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
For subjects receiving weekly treatment, the additional following will be obtained,
performed, or assessed prior to study drug administration:
• 
All subjects (females as well as males) enrolled in the LEN and POM parts will receive 
an educational leaflet appropriate to their treatment, and will receive Pregnancy 
Counselling (see Section 12.2 and Appendix 18.8.1.3 / 18.8.2.3)
• 
Blood sample for endocrinology and predose pharmacokinetics (LEN / POM)
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
For subjects treated with LEN, 12-lead ECG may be performed at the investigator’s 
discretion
Study drug administration:
• 
MOR03087 Study drug administration
• 
DEX, POM, LEN administration according to cohort assignment; POM and LEN will be 
administered daily on Days 1-21 of each 28-day cycle; time point for oral application of 
POM or LEN at start of MOR03087 infusion (+/- 5min). DEX should be given up to 
3 hours prior to MOR03087 infusion start.
The following will be obtained, performed, or assessed after start of study drug administration:
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 
2 and 4 hours after end of infusion
• 
Blood sample for MOR03087 pharmacokinetics (after completion of infusion)
• 
According to cohort assignment, blood samples for POM or LEN pharmacokinetics (after 
completion of infusion)
• 
Response assessment. Note: all responses require two consecutive assessments, and 
should ideally be confirmed at Day 1 of the following cycle.
• 
Ongoing toxicity/AE assessment during the visit
10.1.9 Day 36 Visit (C2D8)
On Day 36, the following will be obtained, performed, or assessed (for weekly treatment prior 
to study drug administration):
• 
Toxicity/AE assessment since last visit
• 
Concomitant medications
Sponsor: MorphoSys AG
Confidential
Page 73 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Blood sample for hematology and serum chemistry
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
For subjects receiving weekly treatment, the additional following will be obtained, performed, 
or assessed prior to study drug administration:
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration) and for predose pharmacokinetics (MOR03087)
• 
Body weight
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
For subjects treated with LEN, 12-lead ECG may be performed at the investigator’s 
discretion
• 
Premedication
For subjects receiving weekly treatment, study drug administration:
• 
MOR03087 Study drug administration
• 
DEX, POM, LEN administration according to cohort assignment; POM and LEN will be 
administered daily on Days 1-21 of each 28-day cycle; time point for oral application of 
POM or LEN at start of MOR03087 infusion (+/- 5min). DEX should be given up to
3 hours prior to MOR03087 infusion start.
For all cohorts the following will be obtained, performed, or assessed after start of study drug 
administration: •
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 2 and
4 hours after end of infusion
• 
Blood sample for MOR03087 pharmacokinetics (after completion of infusion)
• 
Ongoing toxicity/AE assessment during the visit
10.1.10 
Day 43 Visit (C2D15)
The MOR03087 vial(s) have to be obtained from the freezer 3 days to 16 hours before planned 
start of study drug administration. The vials have to be thawed and stored at 2-8°C until 
preparation for administration.
Sponsor: MorphoSys AG
Confidential
Page 74 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
The following will be obtained, performed, or assessed prior to study drug administration:
• 
Toxicity/AE assessment since the last visit
• 
Concomitant medication
• 
Karnofsky performance status
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration), hematology, serum chemistry, endocrinology, anti- 
MOR03087 antibodies, serum M-protein, serum FLCs, and predose pharmacokinetics 
(MOR03087)
• 
Sample from 24-hour urine for urine M-protein
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Body weight
• 
Quality of life questionnaires (QLQ-MY20 and QLQ-C30)
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
• 
Premedication (at the investigator’s discretion if no infusion reaction during Cycle 1)
For subjects receiving weekly treatment, the additional following will be obtained, performed,
or assessed prior to study drug administration:
• 
Blood sample for predose pharmacokinetics (LEN / POM)
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
For subjects treated with LEN, 12-lead ECG may be performed at the investigator’s 
discretion
Study drug administration:
• 
MOR03087 Study drug administration
• 
DEX, POM, LEN administration according to cohort assignment; POM and LEN will be 
administered daily on Days 1-21 of each 28-day cycle; time point for oral application of 
POM or LEN at start of MOR03087 infusion (+/- 5min). DEX should be given up to 
3 hours prior to MOR03087 infusion start.
The following will be obtained, performed, or assessed after start of study drug administration:
Sponsor: MorphoSys AG
Confidential
Page 75 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 
2 and 4 hours after end of infusion
• 
Blood sample for MOR03087 pharmacokinetics (after completion of infusion)
• 
Ongoing toxicity/AE assessment during the visit
For subjects receiving weekly treatment, the additional following will be obtained, performed, 
or assessed after study drug administration:
• 
According to cohort assignment blood samples for POM or LEN pharmacokinetics (after 
completion of infusion)
10.1.11 
Day 50 Visit (C2D22)
On Day 50, the following will be obtained, performed, or assessed:
• 
Toxicity/AE assessment since last visit
• 
Concomitant medications
• 
Blood sample for hematology, serum chemistry, and pharmacokinetics (MOR03087)
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
For subjects receiving weekly treatment, the additional following will be obtained, performed, 
or assessed prior to study drug administration: •
• 
Blood sample for “emergency laboratory” for immediate evaluation before study drug 
administration (only to be taken if hematology/serum chemistry is not available prior to 
study drug administration)
• 
Body weight
• 
12-Lead ECG (for subjects treated with LEN this assessment is at the investigator’s 
discretion)
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
• 
Premedication (at the investigator’s discretion if no infusion reaction during Cycle 1) 
For subjects receiving weekly treatment, study drug administration:
• 
MOR03087 Study drug administration
• 
DEX administration according to cohort assignment. DEX should be given up to 3 hours 
prior to MOR03087 infusion start.
Sponsor: MorphoSys AG
Confidential
Page 76 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
For all cohorts the following will be obtained, performed, or assessed after start of study drug 
administration:
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at 
15 minutes, 30 minutes, and 1 hour after start of infusion; end of infusion; and 2 and 
4 hours after end of infusion
• 
Blood sample for MOR03087 pharmacokinetics (after completion of infusion)
• 
Ongoing toxicity/AE assessment during the visit
10.1.12 
Follow-Up Visits
Follow-Up Visit 1:
After treatment discontinuation without disease progression a follow-up visit will occur 4 weeks 
(± 2 days) after the last dose of study drug.
At this visit, the following will be obtained, performed, or assessed:
• 
Toxicity/AE assessment since the last visit
• 
Concomitant medications
• 
Karnofsky performance status
• 
Blood sample for hematology, serum chemistry, coagulation, PHCG pregnancy test for 
women of childbearing potential, endocrinology, anti-MOR03087 antibodies, serum 
M-protein, serum FLCs, pharmacokinetics (MOR03087), and B, T, and NK cells
• 
Sample from 24-hour urine for urine M-protein
• 
Response assessment. Note: all responses require two consecutive assessments, and 
should ideally be confirmed.
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Body weight
• 
Quality of life questionnaires (QLQ-MY20 and QLQ-C30)
• 
12-Lead ECG, if clinically indicated at the discretion of the investigator
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
For subjects receiving POM or LEN, the additional following will be obtained, performed, or 
assessed: •
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
Sponsor: MorphoSys AG
Confidential
Page 77 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
For women of childbearing potential with irregular cycles in study cohorts that include LEN or 
POM, a pregnancy test (serum or urine) is to be performed 14 days after treatment 
discontinuation.
Follow-Up Visit 2 and Subsequent Follow-Up Visits:
Four weeks (± 2 days) after Follow-up Visit 1, a second follow-up visit will occur. If there is still 
a response to therapy at this visit, then a follow-up visit will be repeated every fourth week 
(± 2 days) until there is a disease progression (but no longer than 3 years), death, or the subject 
starts a new anti-myeloma therapy. Follow-up visits may be delayed for a maximum of 2 weeks 
after the normal visit window due to other reasons (e.g., logistical).
At each of these visits, the following will be obtained, performed, or assessed:
• 
Toxicity/AE assessment since the last visit
• 
Concomitant medication
• 
Karnofsky performance status
• 
Blood sample for hematology, serum chemistry, PHCG pregnancy test for women of 
childbearing potential, anti-MOR03087 antibodies (at Follow-up Visit 2 only), B, T, and 
NK cells, serum M-protein, and serum FLCs
• 
Sample from 24-hour urine for urine M-protein
• 
Response assessment, to be continued until disease progression or death or subsequent 
anti MM therapy start whatever occurs first. Note: all responses require two consecutive 
assessments, and should ideally be confirmed at the next follow-up visit.
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Body weight
• 
Quality of life questionnaires (QLQ-MY20 and QLQ-C30)
• 
12-Lead ECG, if clinically indicated at the discretion of the investigator
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
10.1.13 Treatment Cycles 3+ Visits
Subjects with an ongoing response of at least SD subsequent to the end of cycle 2 will be offered 
continued treatment with MOR03087 until disease progression or death or start of new 
anti-myeloma treatment.
Sponsor: MorphoSys AG
Confidential
Page 78 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
At the discretion of the investigator, subjects with disease progression or a status no better than 
stable disease after four cycles may be treated with up to 40 mg DEX (elderly subjects aged 
> 75 years should receive 20 mg) per week if not otherwise receiving DEX via assigned cohort. 
Only subjects who do not present with known or suspected hypersensitivity to DEX or any of 
the excipients could qualify for the treatment with DEX (see exclusion criterion for the 
concomitant treatment of MOR03087 and DEX, Section 8.2). DEX must be administered as a 
single oral dose.
In case subjects are treated with DEX in the course of the study, the investigator may decide to 
decrease the dose of DEX when medically justified in the light of signs and symptoms resulting 
from the excess of glucocorticosteroids. The investigator must then adhere to the rules of local 
medical practice and their clinical judgment in the process, ensuring that subject treatment is 
stable (down-titration completed) prior to the End of Study (EOS) visit.
In case a subject discontinues treatment for reasons other than disease progression, they should 
proceed to the Follow-up Visit.
All subjects (females as well as males) continuing in the LEN and POM parts will receive an 
educational leaflet appropriate to their treatment, and will receive Pregnancy Counselling (see 
Section 12.2 and Appendix 18.8.1.3 / 18.8.2.3) at Day 1 of each cycle, starting with Cycle 3+.
At each ongoing treatment visit, the following will be obtained, performed, or assessed prior to 
study drug administration:
• 
Toxicity/AE assessment since the last visit
• 
Concomitant medication
• 
Karnofsky performance status only at Day 1 (CxD1) of each cycle, starting with Cycle 3+
• 
Laboratory assessments according to local guidelines/practice for the administration of 
monoclonal antibodies at the local laboratory should be performed. The assessment at 
the local laboratory should contain at the minimum serum chemistry including the 
“emergency laboratory parameters” and calcium concentration, and hematology
• 
Urine pregnancy test for women of child-bearing potential only at Day 1 (CxD1) of each 
cycle, starting with Cycle 3+
• 
Serum M-protein and serum free light chains only at Day 1 (CxD1) of each cycle, starting 
with Cycle 3+
• 
Sample from 24-hour urine for urine M-protein only at Day 1 (CxD1) of each cycle, 
starting with Cycle 3+
• 
B, T and NK cells at Day 15 (CxD15) of each cycle, starting with Cycle 3+
• 
Blood sample for predose pharmacokinetics (MOR03087) and anti-MOR03087 
antibodies every CxD15
• 
Response assessment on Day 1 of every cycle (CxD1), to be continued until disease 
progression or death or subsequent anti MM therapy start whatever occurs first. Note: all 
responses require two consecutive assessments, and should ideally be confirmed at Day 1 
of the next cycle
Sponsor: MorphoSys AG
Confidential
Page 79 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Body weight
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature 
immediately before infusion)
• 
Premedication (at the investigator’s discretion if no infusion reaction during Cycle 1)
For subjects receiving POM or LEN, the additional following will be obtained, performed, or
assessed prior to study drug administration:
• 
12-lead ECG
o 
For subjects treated in Part D (POM), 12-lead ECG monitoring will be performed 
on Cycle 3 Day 1, and on Day 1 of every third cycle thereafter (Cycles 3, 6, 9, 
etc.), and at treatment discontinuation. Subjects with QT prolongation (or 
borderline QT prolongation) but otherwise non-clinically significant will require 
more frequent ECG monitoring at the discretion of the investigator.
o 
For subjects treated in Part E (LEN), 12-lead ECG will be performed at each visit 
during treatment if clinically indicated per investigator's judgment, and at 
treatment discontinuation if clinically indicated per investigator’s judgment
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
• 
Prophylactic treatment of thromboembolism for subjects enrolled into the LEN or POM 
cohorts
Study drug administration:
• 
MOR03087 study drug administration
• 
DEX, POM, LEN administration according to cohort assignment; POM and LEN will be 
administered daily on Days 1-21 of each 28-day cycle; time point for oral application of 
POM or LEN at start of MOR03087 infusion (+/- 5min). DEX should be given up to 
3 hours prior to MOR03087 infusion start.
The following will be obtained, performed, or assessed after start of study drug administration:
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature) at end of 
infusion
• 
Blood sample for pharmacokinetics (MOR03087; after completion of infusion but only 
every CxD15 •
• 
Ongoing toxicity/AE assessment during the visit
Sponsor: MorphoSys AG
Confidential
Page 80 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
10.1.14 End of Study (EOS) Visit
The EOS visit will occur after confirmed disease progression, or after withdrawal from the study 
for other reasons, or at a maximum of 3 years from the first study drug administration. The EOS 
visit will occur at least 28 days after last study drug administration but should be performed 
before any new MM therapy starts, whichever occurs first.
At the EOS visit, the following will be obtained, performed, or assessed:
• 
Toxicity/AE assessment since the last visit
• 
Concomitant medications
• 
Karnofsky performance status
• 
Blood sample for hematology, serum chemistry, coagulation, PHCG pregnancy test for 
women of childbearing potential, MOR03087 pharmacokinetics (only if subject had no 
follow-up visit), endocrinology, anti-MOR03087 antibodies, B, T, and NK cells, serum 
M-protein, and serum FLCs
• 
Urine sample for urinalysis
• 
Sample from 24-hour urine for urine M-protein
• 
Bone skeletal survey by x-ray, CT, or MRI imaging (where medically indicated, as a 
regular assessment of standard of care in subjects with relapsed or refractory MM)
• 
Response assessment
• 
Physical examination (including basic neurological examination of general motor and 
sensory systems, mental status, cranial nerves, and coordination)
• 
Ocular examination by an ophthalmologist (including distance visual acuity, optical 
coherence tomography [if available], and ophthalmoscopy under full mydriasis [if optical 
coherence tomography is unavailable])
• 
Body weight
• 
Quality of life questionnaires (QLQ-MY20 and QLQ-C30)
• 
12-Lead ECG
• 
Vital signs (blood pressure, pulse rate, respiratory rate, and body temperature)
• 
Documentation of subject’s subsequent anti-myeloma therapy, as appropriate
For subjects receiving POM or LEN, the additional following will be obtained, performed, or 
assessed: •
• 
Clinical review of signs/symptoms for possible VTEs in subjects treated with POM or 
LEN. Subjects who develop symptomatic deep vein thrombosis will be assessed and 
diagnosed objectively by Doppler ultrasonography or a comparable method per 
institution’s standard of care. See Appendix 18.9 for deep vein thrombosis and 
pulmonary embolism diagnostic algorithms
Sponsor: MorphoSys AG
Confidential
Page 81 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
11 EFFICACY, PHARMACOKINETIC, SAFETY, AND OTHER 
VARIABLES
The endpoints to be assessed for this study are as follows:
Primary Endpoints
1. Determination of the MTD and/or recommended dose of MOR03087 as monotherapy, in 
combination with DEX, and in combination with POM+DEX and LEN+DEX
2. Determination of the recommended dosing regimen of MOR03087
3. Incidence and severity of adverse events (AEs)
4. Immunogenicity of MOR03087 based on both absolute (number and percentage of 
subjects 
who 
develop 
anti-MOR03087 
antibodies) 
and 
semi-quantitative 
(anti-MOR03087 antibody titer determination of confirmed positive samples) 
assessments
Secondary Endpoints
1. Pharmacokinetics of MOR03087 +/- LEN or POM
2. Absolute and percent change from baseline in measurements of B, T, and NK cell 
populations
3. Overall response rate (stringent complete response [sCR], complete response [CR], very 
good partial response [VGPR], partial response [PR]), further tumor response rates (CR, 
stringent complete response [sCR], PR, minimal response [MR], VGPR), and SD rate
4. Duration of response, time to progression (TTP), and PFS
5. Absolute and percentage change from baseline in serum and urine M-protein levels
6. Absolute and percent change from baseline in serum FLC levels and serum FLC ratio
7. Absolute changes from baseline in laboratory parameters (serum chemistry, hematology, 
urinalysis) and clinically relevant abnormal values
8. Absolute change from baseline in overall quality of life scores
9. Change in cytokines from baseline
11.1 Efficacy and Pharmacodynamic Assessments
11.1.1 Efficacy Assessment
Efficacy will be evaluated in terms of overall response rate (ORR) (sCR + CR + VGPR + PR) 
(Kyle 2009), further tumor response rates (CR, sCR PR, MR, VGPR), SD rate, duration of 
response, TTP, and PFS, using the modified European Group for Blood and Marrow 
Transplantation (EBMT) criteria (Blade 1998) plus the International Myeloma Working Group 
Uniform Response Criteria (2006), taking the supplement by Kyle (Kyle 2009) into 
consideration.
All of these tumor response criteria for MM are defined in Appendix 18.3. All of them are based 
on the International Myeloma Working Group Uniform Response Criteria (Durie 2006 and
Sponsor: MorphoSys AG
Confidential
Page 82 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Erratum 2007), except for MR, which is based on the EBMT criteria (Blade 1998). Disease 
progression is defined as progressive disease according to the IMWG, 2006 (see Appendix 18.3, 
Table 14), death or start of new anti-MM treatment.
All responses need two consecutive assessments, ideally being confirmed at Day 1 of the next 
cycle.
The response evaluation will be based on serum and urine M-protein levels, serum FLC level, 
and FLC ratio.
11.1.2 Immune Cells
For evaluation of the status of the immune system, B, T, and NK cells will be measured 
frequently throughout the study. The absolute and percent changes from baseline will be 
evaluated.
Flow cytometry of peripheral MM cells and CD16 expression on NK cells will be evaluated at 
baseline and at Day 29 (Cycle 2 Day 1) (exploratory assay).
Pending sample availability, endogenous antibody titers (e.g., tetanus titers) will be measured 
from remaining anti-MOR03087 antibody back-up samples in order to gain information about 
the influence of MOR03087 treatment on normal plasma cells and immunity, especially when 
MOR03087 is administered over extended periods of time.
11.1.3 Bone Marrow
Pharmacodynamics will also be assessed in terms of changes in bone marrow for subjects with 
negative immunofixation on the serum and urine. For subjects with positive immunofixation of 
the serum and urine, bone marrow is to be assessed only if specific consent for this assessment 
has been provided. Changes from baseline in histology and immunophenotyping (CD38 
expression) will be assessed depending on sample availability, at Day 29 (Cycle 2 Day 1).
11.2 Pharmacokinetic Assessments
Concentration-time profiles and pharmacokinetic parameters will be assessed for MOR03087 
and, as applicable, for POM and LEN, from serum or plasma samples collected on the following 
schedules (if not otherwise specified, a deviation of 5 minutes from the planned collection time 
point is acceptable, but time of collection should be documented accurately.):
Parts A, B, C:
M O R 03087
• 
For the first MOR03087 administration, serum samples will be collected predose and 
then 1, 2, 4, 8, 14 ± 2 (optional), 22 ± 2, and 28 ± 2 hours after start of first infusion.
• 
For all other MOR03087 administrations in Cycles 1 and 2, serum samples will be 
collected predose for trough level determination and then after completion of infusion 
(subjects in bi-weekly dosing will not have a dose on Day 50, so require only one serum 
sample that day).
Sponsor: MorphoSys AG
Confidential
Page 83 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
o 
From Cycle 3 onwards, samples will be collected once per cycle (predose and 
after completion of infusion). This means sampling every cycle on D15.
• 
Follow-up: sample will be collected at follow-up visit 1 (or at EOS if no follow-up visit 
occurrs)
Parts D, E:
M O R 03087 com bin ed w ith L E N  or P O M  regim ens dose escalation
• 
For the first MOR03087 administration, MOR03087 serum samples will be collected 
predose before administration of MOR03087 + LEN or POM and then 1, 2, 4, 8, 14 ± 2 
(optional), 22 ± 2, and 28 ± 2 hours after start of first infusion of MOR03087
• 
For all other MOR03087 administrations in Cycles 1 and 2, MOR03087 serum samples 
will be collected predose for trough level determination and after completion of infusion
• 
For the first MOR03087 administration, POM or LEN plasma samples will be collected 
predose before administration of MOR03087 + LEN or POM and then 1, 2, 8 and 22 ± 2 
hours after start of first infusion of MOR03087
• 
For the 3rd, 6th and 8th MOR03087 administration in Cycles 1 and 2, POM or LEN plasma 
samples will be collected predose for trough level determination and after completion of 
infusion
• 
From Cycle 3 onwards, samples will be collected once per cycle (predose and after 
completion of infusion). This means sampling every cycle on D15.
• 
Follow-up: MOR03087 serum sample will be collected at follow-up visit 1 (or at EOS if 
no follow-up visit occurred)
Serum samples for MOR03087 pharmacokinetic analysis will be handled and stored at -20°C or 
below at the site until shipment on dry ice to an external analytical laboratory. Samples for LEN 
or POM pharmacokinetic analysis will be handled and stored at -70°C at the site until shipment 
on dry ice to an external analytical laboratory. At the analytical laboratories, the samples will 
also be stored at or below -20°C or -70°C, respectively, until analysis.
Detailed instructions for handling of serum samples will be provided in the laboratory-specific 
documentation.
11.3 Safety Assessments
Safety monitoring for all subjects enrolled in the study will include laboratory safety assessments 
(hematology, blood and urine chemistry) and clinical evaluations (physical examinations, vital 
signs, 12-lead ECG) as detailed in the schedules of assessments (Section 7.1) and Section 11.3.4. 
All AEs and serious AEs (SAEs) will be recorded.
All AEs and SAEs will be graded according to NCI CTCAE, version 4.0. For definition of DLTs, 
please refer to Section 8.5.
Sponsor: MorphoSys AG
Confidential
Page 84 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
11.3.1 Adverse Events
Study personnel must remain vigilant for the occurrence of AEs, particularly those that may be 
life-threatening. Personnel who are trained in the acute management of infusion reactions, 
anaphylaxis, and other emergencies and who have access to appropriate clinical supplies must 
be immediately available for no less than 30 minutes after dosing.
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), 
symptom(s), or medical condition(s) occurring after signing the informed consent even if the 
event is not considered to be related to the study drug(s). Please refer to Sections 9 and 10 for 
the protocol-specific definitions of study drug and study treatment. An AE can therefore be any 
unfavorable and unintended sign, symptom, or disease temporally associated with the use of an 
IMP, whether or not considered related to that IMP. AEs include any clinically significant 
deterioration of a subject’s medical status after signing of the informed consent form.
Any abnormal laboratory value judged to be clinically significant is defined as AE.
The subjects will be closely observed and questioned for any kind of AE during the study 
procedures and at follow-up appointments throughout the study period with non-leading 
questioning (e.g., “How do you feel?”). AEs also may be detected when they are volunteered by 
the subject during or between study visits or through physical examination, laboratory tests, or 
other assessments. As far as possible, each AE should be evaluated to determine the following:
• 
Relationship to study drug (suspected/not suspected)
• 
Duration (start and end date or if continuing at end of study)
• 
Intensity
• 
Toxicity grade
• 
Outcome
• 
Action taken (no action taken; dose reduction; study drug temporarily interrupted; study 
drug permanently discontinued due to this adverse event; concomitant medication taken; 
non-drug therapy given; hospitalization/prolonged hospitalization)
• 
Whether it is serious, where a serious adverse event (SAE) is defined as one which:
o 
Results in death. 
o 
Is life-threatening.
o 
Requires inpatient hospitalization or prolongation of existing hospitalization, 
unless hospitalization is for
• 
Routine treatment or monitoring of the studied indication, not associated 
with deterioration of symptoms related to MM
• 
Elective or preplanned treatment for a preexisting condition that is 
unrelated to MM and has not worsened since signing of the informed 
consent
• 
Treatment on an emergency outpatient basis for an event not fulfilling any 
of the definitions of an SAE given in this section and not resulting in 
hospital admission
Sponsor: MorphoSys AG
Confidential
Page 85 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Social reason and respite care in the absence of any deterioration in the 
subject’s general condition
o 
Results in persistent or significant disability or incapacity. 
o 
Is a congenital anomaly or birth defect.
o 
Is medically significant, i.e., defined as an event that jeopardizes the subject or 
may require medical intervention to prevent one of the outcomes listed above.
NOTE: The term “life-threatening” refers to an event in which the subject was, in the view of 
the reporting investigator, at immediate risk of death at the time of the event; it does not refer to 
an event that hypothetically might have caused death if it were more severe. Medical judgment 
should be exercised in deciding whether an AE/reaction is serious in other situations: Important 
AEs/adverse drug reactions (ADRs) that are not immediately life-threatening or do not result in 
death or hospitalization but may jeopardize the subject or may require intervention to prevent 
one of the other outcomes listed in the definitions above, should also be considered serious.
Unlike routine safety assessments, SAEs are monitored continuously and have special 
reporting requirements (see Section 12.1).
All AEs should be treated appropriately. Such treatment may include changes in study drug 
treatment including possible interruption or discontinuation, starting or stopping concomitant 
treatments, changes in the frequency or nature of assessments, hospitalization, or any other 
medically required intervention. Once an AE is detected, it should be followed up until resolution 
or until the EOS visit, and an assessment should be made at each visit (or more frequently, if 
necessary) of any changes in its severity, its suspected relationship to the study drug(s), any of 
the interventions required to treat it, and its outcome.
Information about common side effects already known about the investigational study drugs can 
be found in the IB or SmPCs, as applicable, or will be communicated between IB or SmPC 
updates in the form of Investigator Notifications. This information will be included in the subject 
informed consent form and should be discussed with the subject during the study as needed.
11.3.2 Physical Examination
A qualified physician will conduct physical examinations before study drug administration. The 
physical examination will include an assessment for the presence of abnormalities of the 
following: general appearance, skin, head, eyes, ears, nose, throat, lungs, breasts and axillae, 
cardiovascular system, back and spine, abdomen, extremities, infusion site, lymph nodes, and 
basic neurological examination (general motor and sensory systems, mental status, cranial 
nerves, and coordination).
At Screening and End of Study, an ocular examination should be conducted by an 
ophthalmologist (including distance visual acuity, optical coherence tomography [if available], 
and ophthalmoscopy under full mydriasis [if optical coherence tomography is unavailable]).
In the event that new and worsening abnormal physical examination findings are encountered 
during the study, these terms are defined as follows: A new abnormal physical examination 
finding is defined as one that occurs when a subject’s normal baseline physical examination 
becomes abnormal post baseline, based on clinical grounds. A worsening abnormal physical
Sponsor: MorphoSys AG
Confidential
Page 86 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
examination finding is defined as one that occurs when a subject’s abnormal baseline physical 
examination becomes worse post baseline, also based on clinical grounds. Any new and/or 
worsening findings should be recorded as AEs.
11.3.3 Vital Signs
Vital signs will be measured at the various pre- and post-treatment time points described in the 
flow charts in Section 7.1. Vital sign parameters include measurements of pulse rate, systolic 
and diastolic blood pressures, respiratory rate, and body temperature. Before vital signs are 
measured, the subject should be resting for at least 5 minutes (if possible). The same position 
will be used each time vital signs are measured for a given subject, and blood pressure will be 
measured from the arm contralateral to the site of IMP administration whenever possible. Body 
temperature should be measured with a digital thermometer.
The actual time for measurement of vital signs should not deviate more than 5 minutes from the 
planned time.
11.3.4 Laboratory Evaluations
Clinical laboratory parameters to be assessed in this study are displayed in Table 11.
Sponsor: MorphoSys AG
Confidential
Page 87 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Table 11 
Laboratory Evaluations
Evaluation
Analysis
Sample Collection
(approximate amount per 
collection)
“Emergency laboratory”
(EDTA blood and serum 
sample)
Serum creatinine, hemoglobin, white blood 
cells (WBC), platelets, sodium, potassium, 
aspartate aminotransferase (AST), alanine 
aminotransferase (ALT)
Same sample as for 
chemistry and hematology
Hematology 
(EDTA blood)
WBC with differential, hematocrit, 
hemoglobin, mean corpuscular volume, 
platelet count, red blood cell (RBC) count
5 mL blood
Serum chemistry
(Serum sample)
ALT, albumin, alkaline phosphatase, amylase, 
AST, bicarbonate (optional), bilirubin (total), 
blood urea nitrogen, calcium, chloride, 
creatinine, creatine kinase, gamma- 
glutamyltransferase (GGT), glucose, lactate 
dehydrogenase, lipase, phosphorus, potassium, 
protein (total), sodium, uric acid, 
P2-microglobulinb
10 mL blood
Coagulation parameters
(Sodium citrate blood)
Activated partial thromboplastin time (aPTT), 
prothrombin time (PT)
3 mL of blood
Endocrinology
(Serum sample)
Follicle-stimulating hormone (FSH), thyroid- 
stimulating hormone (TSH)
Same sample as for 
chemistry
Serology parameters
(Serum sample)
Hepatitis B: HBsAg and anti-HBs; 
Hepatitis C: Anti-HCV, (HCV RNA 
quantification if anti-HCV-positive)
Same sample as for 
chemistry
Pregnancy test
(Serum sample)
P human chorionic gonadotropin (PHCG) 
serum, females of childbearing potential only
Same sample as for 
chemistry
Pregnancy test
(Urine)
PHCG urine, females of childbearing potential 
only
30 mL (midstream urine)
Urinalysis
Specific gravity, pH, semiquantitative 
“dipstick” evaluation of glucose, protein, 
bilirubin, ketones, leucocytes, RBCs, and 
microscopic evaluation if abnormal findings
30 mL (midstream urine)
Serum M-Protein, FLC
M-protein, serum free light chains
10 mL of blood
M-protein (urine)
M-protein quantification
2x 10 mL out of 24h-urine 
sampling
Immune cells (blood)
B, T, NK cell population 
CD16 expression on NK cells
2 mL of blood
(for CD16 expression, same
sample as for flow
cytometry)
Flow cytometry (blood)
Peripheral blood plasma (MM) cells (CD38 
expression)
2 mL of blood
Immunophenotyping (bone 
marrow)
Bone marrow plasma (MM) cells (CD38 
expression)
6 mL bone marrow aspirate
Histology (bone marrow)
Microscopic examination
6 mL bone marrow aspirate 
(same aspirate as for 
Immunophenotyping)
Biomarkers (bone marrow)
Potential identification of biomarkers
6 mL bone marrow aspirate 
(same aspirate as for 
Immunophenotyping)
Cytogenetics (bone marrow)
Cytogenetics of MM cells
6 mL bone marrow aspirate 
(same aspirate as for 
Immunophenotyping)
Sponsor: MorphoSys AG
Confidential
Page 88 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Table 11 
Laboratory Evaluations
Immunogenicitya
(serum sample)
Anti-MOR03087 antibodies
4 mL of blood
Cytokines
(serum sample)
Tumor necrosis factor alpha (TNF-a), 
interleukin-1b (IL-1b), interleukin-2 (IL-2), 
interleukin-6 (IL-6), interleukin-10 (IL-10) 
interferon-Y (IFN-y)
4 mL of blood
Pharmacokinetics 
MOR03087a (Serum sample)
MOR03087
4 mL of blood
Pharmacokinetics POM or
LENa (Plasma sample)
POM or LEN
3 mL of blood
Genotyping
FcYRIIIa polymorphism
Mucosal cheek swab
a Provided sufficient quantities of serum are available, additional measurements of tetanus titer will be 
performed by central laboratories 
b p2-microglobulin measured at screening only
The signed and interpreted laboratory results will be kept as supplemental pages to the subject’s 
eCRF.
With the exception of pharmacokinetic parameters, anti-MOR03087 antibodies, cytokines, 
CD16 expression, and flow cytometry, all clinical laboratory parameters (see Table 11) will be 
analyzed at the local hospital laboratories. Samples for M-Protein and FLC will be analyzed 
centrally in order to be able to evaluate potential variances and to assess additional time points. 
Tetanus titers will be analyzed by a central laboratory. All blood samples will be processed and 
handled according to standard laboratory procedures.
Serum samples will be collected for pharmacokinetic parameters (MOR03087), anti-MOR03087 
antibodies and cytokines and stored at -20°C or below at the study site until shipment on dry ice 
to the external analytical laboratory. At the analytical laboratory, the samples will also be stored 
at -20°C or below until analysis.
Plasma samples will be collected for pharmacokinetic parameters (LEN or POM) and stored 
at -70°C at the study site until shipment on dry ice to the external analytical laboratory. At the 
analytical laboratory, the samples will also be stored at -70°C or below until analysis.
Detailed instructions for sample handling will be provided in the laboratory manual.
Before the initial administration of study drug (MOR03087, POM, or LEN), the respective 
inclusion and exclusion criteria defined in Sections 8.1 and 8.2 should be followed. For all 
administrations of MOR03087, the following parameters should be taken predose on the day of 
study drug administration and, if outside the limits described below, administration of 
MOR03087 should be postponed (see Section 8.6):
Sponsor: MorphoSys AG
Confidential
Page 89 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Value
Subject should not be dosed if the value is:
Creatinine
> 3 x ULN
Hemoglobin
< 8.0 g/dL (subject should be transfused before dosing)
Platelets
< 25.0 x 109/L (< 30.0 x 109/L in the LEN and POM parts)
WBC
< 1.0 x 109/L
Potassium
> 6.0 mmol/L
Sodium
> 155 mmol/L
AST/ALT
> 3 x ULN
POM, LEN or DEX may have to be interrupted and/or dose reduced as well, according to 
Section 9.1.4.
Urine will be collected at the various pre- and post-treatment time points described in the flow 
charts in Section 7.1. The time of void will be documented on the eCRF. In the case of any 
abnormal result, a microscopic urine examination should be conducted. For the evaluation of 
urine M-protein 24-hour urine is required and has to be sent to the central laboratory. If urine 
was collected as standard of care, it is acceptable to use 24-hour urine samples for which 
collection started up to 48 hours before the respective visit.
A pregnancy test will be performed for women of childbearing potential at various pre- and post­
treatment time points either by urine pregnancy test or PHCG test of a serum sample. The 
pregnancy test assay should have a minimum sensitivity of 25 IU/mL. On dosing days, the result 
must be available prior to IMP administration.
Laboratory results should be reviewed in a timely manner (i.e., hematology and chemistry prior 
to dosing). Emergency laboratory samples should only be taken if hematology and serum 
chemistry results are not available prior to study drug administration. Judgment of clinical 
significance should be added on the printout for out of range laboratory values, and the printout 
should be dated and signed.
Emergency Laboratory instruments for measuring parameters relevant for treatment decisions 
and for documentation of laboratory AEs have to be adequately qualified. In case of 
discrepancies between the emergency laboratory and principal local laboratory values, the 
emergency laboratory value should be the relevant value if the emergency laboratory value was 
used to decide on treatment (administration, continuation or interruption). Further, laboratory 
AEs should be followed up by the instrument with which the laboratory AE was first reported.
If an abnormal laboratory value of grade 4 or an abnormal laboratory value judged to be clinically 
significant is not reported as an AE, then the investigator should clearly document the rationale 
for not doing so in the source documentation.
Any abnormal laboratory findings that constitute an AE should be reported as such and should 
be followed up until the outcome is known. Also, additional diagnostic tests may be indicated to 
determine a more precise diagnosis of the subject’s condition (e.g., ordering a WBC differential 
count to help characterize a high or low WBC count, or ordering a determination of RBC indices 
to help characterize a low hematocrit).
Sponsor: MorphoSys AG
Confidential
Page 90 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Detailed instructions and amounts of blood needed for the respective laboratory measurement, 
as well as details of which local or central laboratory is involved for the respective laboratory 
measurements, will be summarized in laboratory manuals.
Blood samples will be obtained for assessment of serum chemistry, hematology, and coagulation 
parameters at the various pre- and post-treatment time points described in the flow charts in 
Section 7.1. The time of blood collection should be documented in the eCRF.
11.3.5 Electrocardiogram
A standard 12-lead ECG will be obtained at the various time points described in the flow charts 
in Section 7.1. A 12-lead ECG will be recorded after 5 minutes in a supine position. Heart rate 
and RR, PR, QS, and QT intervals will be determined. All ECG recordings will be reviewed on 
an ongoing basis at the site. The investigator will evaluate the clinical significance of each value 
outside the reference ranges, based upon the nature and degree of the observed abnormality. Any 
new abnormal values considered to be clinically significant should be reported as AEs.
11.4 Other Variables
11.4.1 Demographic Data
Demographic variables to be recorded will include age, gender, race, height, and body weight. 
Weight and height should be measured while the subject is without shoes, but dressed.
11.4.2 Relevant Medical History and Current Medical Conditions
Relevant medical history and current medical conditions will be recorded until the start of the 
study drug administration.
The medical history of MM should be documented in detail. This should include the date of first 
diagnosis, previous treatments, best response under respective drug treatment with 
corresponding date, duration of response to these treatments and date(s) and type(s) of disease 
progression. Any previous therapy (e.g., chemotherapy, immunotherapy, or radiation therapy) 
for the myeloma-specific therapy should be recorded in the eCRF. Disease staging will be 
determined based on Durie-Salmon and ISS criteria (see Appendix 18.6) and immunoglobulin 
type will be documented.
Examinations leading to the diagnosis of the latest progression of MM should be documented in 
the eCRF as well. This may include, for example, results of laboratory examinations (e.g., 
M-protein), imaging results (e.g., x-ray, computed tomography, magnetic resonance imaging), 
or clinical symptoms related to the MM (e.g., bone pain).
All prior VTEs and pulmonary embolisms will be documented.
11.4.3 Prior and Concomitant Medication and Examinations
All prior medications in use at the time of study enrolment and all concomitant medications used 
during the study period will be recorded in the source document and on the eCRF.
Sponsor: MorphoSys AG
Confidential
Page 91 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Further examinations that constitute standard measures and are not covered by the protocol are 
left to the discretion of the investigator. However, such examinations performed during the study 
should be documented in the eCRF as well.
11.4.4 Bone Marrow Aspiration/Biopsy
At the Screening visit (Baseline), a bone marrow aspirate and a biopsy should be obtained if no 
bone marrow aspiration or biopsy was obtained within 28 days prior to first dose, provided the 
subject was hematologically stable in the meantime. If data from a bone marrow sample taken 
before the screening are used, then data should be limited to the available information.
Bone marrow is to be assessed on Day 29 (C2D1) only if specific consent for this assessment 
has been provided.
The following examinations are planned:
• 
Histology: Percentage of infiltration by plasma cells
• 
Immunophenotyping of MM cells: CD38 expression (exploratory assay)
• 
Cytogenetics of MM cells: Determination of translocations t(4; 14) and t(14; 16) and 
deletions Del13 and Del17p13 as well as other cytogenetic aberrations with possible 
prognostic and/or predictive relevance in myeloma (e.g., 1q gain, t(11;14)) at screening 
if no historical data are available
11.4.5 Pharmacogenetics and Genotyping
For subjects who agree to it by signing an additional informed consent, an extra bone marrow 
sample for analysis of biomarkers (e.g., DNA, RNA) will be collected at screening. The primary 
purpose of this analysis would be to understand possible pharmacokinetic and pharmacodynamic 
variability as a result of genetic heterogeneity in the study population.
Additionally, a mucosal cheek swab will be used for DNA analysis of the FcYRIIIa 
polymorphism.
Further hypothesis-driven genotyping may be performed on specific genes of special interest. In 
addition, to better understand underlying disease mechanisms, discovery-driven genotyping with 
open-platform methodologies may be performed for the definition of endophenotypes, 
i.e., substratification of disease groups according to genetic patterns.
11.4.6 Subject-reported Outcomes
Subject-reported outcomes and quality of life will be assessed using the QLQ-C30 (version 3) 
and QLQ-MY20 questionnaires developed by the European Organisation for Research and 
Treatment of Cancer (EORTC) (Sprangers 1998, Stead 1999). The QLQ-C30 instrument is a 
reliable and validated 30-item questionnaire composed of five functional scales (physical, role, 
emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain) 
and a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite 
loss, constipation, diarrhea, and financial difficulties). The QLQ-MY20 instrument is a 20-item
Sponsor: MorphoSys AG
Confidential
Page 92 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
disease-specific modular questionnaire regarding subject-reported symptoms or problems. Both 
quality of life instruments will be completed by the subject.
12 SAFETY MONITORING
12.1 Adverse Event and Serious Adverse Event Recording and Reporting
All AEs/SAEs (except non-serious AEs for screening failures) that occur after the signing of 
informed consent and up to the End of Study visit (or up to 28 days after the last administration 
of study medication, whichever is earlier), will be recorded in the eCRF and in the subject’s 
medical records, whether or not considered by the investigator to be related to the study drug. 
The SAEs should thereafter be recorded in the SAE Report Form and reported to the sponsor. 
All AEs/SAEs should be recorded using acceptable diagnoses, if possible. For screening failure 
subjects the non-serious AEs will not be recorded in the eCRF but only in the subject’s medical 
records. The SAEs for screening failures will only be recorded until (including) the day when a 
subject is officially declared as screening failure.
Infusion reactions of grade 3 and higher, cytokine release syndrome, or allergic reaction to 
MOR03087, which are AEs of special interest in this study, should be reported along with their 
respective symptoms (e.g., urticaria, chills, and pyrexia for infusion reaction). If an AE has 
already been reported, it is not necessary to report each individual sign and symptom of that AE 
as a separate AE. For example, if myocardial infarction is reported as an AE, there is no need to 
report elevated creatine phosphokinase and abnormal ECG, or other related signs, symptoms, or 
laboratory values as separate AEs. However, if both occurred in isolation and myocardial 
infarction was not diagnosed, then each event would be reported as an AE.
Second primary malignancies will be monitored as events of special interest regardless of the 
treatment arm the subject is in. This includes any second primary malignancy, regardless of 
causal relationship to IP occurring at any time for the duration of the study. Events of second 
primary malignancy are to be reported using the SAE report form and must be considered an 
“Important Medical Event” if no other serious criteria apply. Documentation on the diagnosis of 
the second primary malignancy must be provided at the time of reporting (e.g., any confirmatory 
histology or cytology results, x-rays, CT scans, etc.).
The intensity of all AEs will be graded as mild, moderate, or severe using the following 
definitions:
• 
Mild: 
Tolerable
• 
Moderate: 
Interferes with normal activity
• 
Severe: 
Incapacitating (causes inability to perform usual activity or work)
The toxicity grade of AEs will be graded according to the NCI CTCAE (version 4.0 of May 28, 
2009) using the following definitions:
• 
Grade 1: 
Mild; asymptomatic or mild symptoms; clinical or diagnostic
observations only; intervention not indicated.
• 
Grade 2: 
Moderate; minimal, local or non-invasive intervention indicated;
limiting age-appropriate instrumental activities of daily living (refers to
Sponsor: MorphoSys AG
Confidential
Page 93 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
preparing meals, shopping for groceries or clothes, using the telephone, 
managing money, etc.).
• 
Grade 3: 
Severe or medically significant but not immediately life-threatening;
hospitalization or prolongation of hospitalization indicated; disabling; 
limiting self-care activities of daily living.
• 
Grade 4: 
Life-threatening consequences; urgent intervention indicated.
• 
Grade 5: 
Death related to AE.
The causal relationship of all AEs to IMP intake will be judged as either suspected or not 
suspected. If no relationship has been provided by the investigator, the event will be considered 
as related to study drug and notified to authorities according to regulatory reporting 
requirements.
In addition to the investigator’s own description of the AEs, each AE will be encoded by the 
sponsor (or its delegate) according to the current version of the Medical Dictionary for 
Regulatory Activities (MedDRA).
All non-serious AEs must be followed up for a final outcome until resolution or until the EOS 
visit. An outcome of “unknown” is not considered to be an acceptable final outcome. An outcome 
of “not yet resolved” is an acceptable final outcome for non-serious AEs at the end of a subject’s 
participation in a study. SAEs must be followed up for a final outcome until resolution or, if 
resolution becomes unlikely, until stabilization or death. This includes obtaining information on 
recovery and any sequelae and, in case of a fatal outcome, the cause of death. For SAEs which 
are due to progression of MM, follow-up only until the end of subject’s participation in the study 
is acceptable.
will report all reportable events to all competent authorities (including the 
European Medicines Agency [EMA]), IECs or Institutional/Independent Review Boards (IRBs), 
and investigators as required by local regulations and Premier Research standard operating 
procedures (SOPs).
Sites are instructed to report all SAEs and AEs of special interest (i.e., infusion reactions 
of grade 3 and higher, cytokine release syndrome-allergicreaction to MOR03087, second 
primary malignancies and DLTs) to 
within 24 hours using the
study-specific SAE report form.
Notification of initial or follow-up SAE informationfusmgthe standard SAE form provided by
the sponsor) must be sent to the attention o f_______________ | Global Pharmacovigilance using
either the following email address or fax number:
Email:
Fax:
For any safety-related questions, please contact ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ G lo b a l Pharmacovigilance by 
telephone, fax or email:
Sponsor: MorphoSys AG
Confidential
Page 94 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
For any protocol-related questions, please contact the
medical monitor:
If the 
medical monitor cannot be reached, then please contact the following
24/7 emergency medical cover phone line:
Telephone:
If the | 
contacted:
medical monitor cannot be reached, then the following person should be
As detailed in the schedules of assessments (Section 7.1) and Section 11.3.4, serum or urine 
pregnancy testing will be carried out at the Screening visit, during treatment, during follow-up 
visits, and at the EOS visit. During the treatment period of the study, urine pregnancy testing 
will be performed locally and can be repeated if required. Any pregnancy that occurs during 
study participation should be reported using a Clinical Study Pregnancy Form. To ensure subject 
safety, each pregnancy of a study subject or a female partner of a studysubjectmust;also be 
reported within 24 hours of learning of its occurrence to ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ G lo b a l 
Pharmacovigilance by fax at the following number:
Female study subjects who become pregnant must be withdrawn from the study.
A newly diagnosed pregnancy in a subject or female partner of a study subject who has received 
study medication is not considered an SAE unless it meets any criteria of seriousness or it is 
suspected that the study medication interacted with a contraceptive method and led to pregnancy.
Sponsor: MorphoSys AG
Confidential
Page 95 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
The pregnancy should be followed up to determine outcome, including spontaneous or voluntary 
termination, details of birth, and the presence or absence of any birth defects or congenital 
abnormalities or maternal and newborn complications. Every infant has to be followed up for 
2 months after delivery.
Cohorts with POM or LEN administration:
Pregnancy Counseling (males and females): Counseling about pregnancy precautions and the 
potential risks of fetal exposure must be conducted for all subjects at screening, at Cycle 1 Day
1 prior to dosing, every 28 days during treatment, and at treatment discontinuation. Refer to 
Appendix 18.8 (pregnancy prevention risk minimization plan).
Pregnancy Testing for Females of Childbearing Potential (FCBP): All FCBP must have two 
medically supervised negative serum or urine pregnancy tests (sensitivity of at least 25 mIU/mL) 
prior to starting the study. The first pregnancy test must be performed within 10-14 days prior to 
the start of study treatment and the second pregnancy test must be performed within 24 hours 
prior to the start of study treatment. FCBP with regular or no menstrual cycles must agree to 
have pregnancy tests every 7 days (weekly) for the first 4 weeks of study treatment and then 
every 4 weeks while on study, at treatment discontinuation, and 4 weeks following treatment 
discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for 
the first 4 weeks and then every 2 weeks while on study, at treatment discontinuation, and at
2 weeks and 4 weeks following treatment discontinuation. Study drug may not be dispensed for 
FCBP until the investigator has verified that the result of the pregnancy test is negative.
12.3 Venous Thrombotic Event Monitoring
In subjects randomized to receive either POM or LEN, all prior VTEs and pulmonary embolisms 
that occurred will be collected with complete medical history during the screening period. 
Clinical review of signs/symptoms for possible VTEs will be performed at every scheduled visit 
during study treatment, and at treatment discontinuation. Subjects who develop symptomatic 
deep vein thrombosis will be assessed and diagnosed objectively by Doppler ultrasonography or 
a comparable method per institution’s standard of care. See Appendix 18.9 for deep vein 
thrombosis and pulmonary embolism diagnostic algorithms.
12.4 Independent Data Monitoring Committee
An independent DMC will be constituted prior to the enrolment of the first subject into a new 
cohort.
The DMC membership, full scope of responsibilities, operating procedures, meeting frequency, 
data availability, reporting and record keeping requirements will be described in the DMC 
charter. Recommendations for dose escalation, additional review of the current cohort, or 
termination of the study will be presented in the DMC Charter.
No DMC members will be participating as investigators in the study. The DMC will review the 
safety data as per the charter.
Sponsor: MorphoSys AG
Confidential
Page 96 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
13 PROTOCOL AMENDMENTS AND OTHER CHANGES IN STUDY 
CONDUCT
13.1 Protocol Amendments
Any changes to the protocol will be made in the form of an amendment.
13.2 Other Changes in Study Conduct
Changes in the study conduct are not permitted. Any unforeseen changes in the study conduct 
will be recorded in the Clinical Study Report.
14 DATA HANDLING AND ARCHIVING
14.1 Completing and Signing Case Report Forms
Electronic CRFs will be used in this study. Data will be entered by trained site personnel, with 
reasons given for any missing data. Any errors should be corrected within the electronic system. 
The audit trail will record all changes made, the date and time of the correction, and the person 
correcting the error. The appropriate electronic signature will be provided. The investigator will 
receive a printout of the eCRF after database lock for archiving.
14.2 Clinical Data Management
The CRO will be responsible for the processing and quality control of the data according to the 
CRO’s SOPs. Data management will be carried out by the CRO. The handling of data, including 
data quality control, will comply with all applicable regulatory guidelines.
Details for data validation and edit checks will be described in appropriate data management 
documents. Queries will be handled via the eCRF system. Data cleaning will continue until all 
queries are resolved.
Medical coding will use MedDRA for AEs and the World Health Organization-Drug Dictionary 
Enhanced (WHO-DDE) for medication.
14.3 Archiving and Filing
All study documentation at the investigator site and sponsor site will be archived in accordance 
with ICH E6 Good Clinical Practice (GCP) and the sponsor’s quality standards and SOPs in the 
relevant current version.
15 STATISTICAL METHODS AND PLANNED ANALYSIS
15.1 General Statistical Considerations
The following analysis populations will be defined:
Total Population (All Subjects)
The Total Population will consist of all subjects including screening failures. 
Safety Population
Sponsor: MorphoSys AG
Confidential
Page 97 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
The Safety Population will consist of all enrolled subjects who received the IMP at least once.
DLT Evaluable Population
• 
The DLT Evaluable Population will consist of all enrolled subjects who have received at 
least 1 cycle of MOR03087 (at least four doses for q1w or two doses for the q2w dosing 
schedule) (monotherapy or combination therapy) and if applicable per cohort, at least 
16 doses of LEN or POM without dose modifications and who have minimum safety 
evaluations, including the first cycle and AEs reported from Day 1 after the start of the 
first infusion until Day 1 of the second cycle (before start of infusion).
-  
Subjects who withdraw before having received the minimum number of 
infusions/doses and safety evaluations due to DLT will be included in the DLT 
evaluable population.
-  
Subj ects who discontinue study treatment or require a dose modification for LEN 
or POM for reasons unrelated to a DLT within the first cycle will be excluded 
from the DLT evaluable population.
Efficacy Evaluable Population
The Efficacy Evaluable Population will consist of all subjects who take at least one dose of IMP 
and who have a baseline and at least one post-baseline efficacy assessment.
Pharmacokinetic Population
The Pharmacokinetic Population will consist of all subjects who have sufficient pharmacokinetic 
data to characterize the time course of MOR03087 or LEN or POM in serum or plasma for the 
first IMP administration at a minimum.
The Safety Population will be used for safety analysis and to analyze immunogenicity and the 
pharmacodynamic endpoints. The DLT Evaluable Population will be used to determine the 
maximum tolerated dose. Summaries for the analysis of tumor response will be provided for the 
Efficacy Evaluable Population and the Safety Population. Pharmacokinetic summaries will be 
presented for the Pharmacokinetic Population.
Tabulations of summary statistics, graphical presentations, and statistical analyses will be 
performed using SAS® software.
Continuous, quantitative variable summaries will include the number of subjects (N) (with non­
missing values), mean, standard deviation, median, minimum, maximum, and first and third 
quartiles.
Categorical, qualitative variable summaries will include the frequency and percentage of subjects 
who are in the particular category.
In general, data will be summarized by treatment arm (A-E) and dose level.
Furthermore, there will be specific summaries for the recommended dose groups of each 
treatment arm. Summaries for recommended dose data will combine data from the confirmation
Sponsor: MorphoSys AG
Confidential
Page 98 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
cohort with the data from the cohort of the dose-escalation scheme that received the same dose 
and regimen and combination treatment (if applicable).
The last pre-administration observation will be used as the baseline value for calculating 
post-administration changes from baseline. All data obtained on the eCRF and entered into the 
database will be provided in separate data listings showing individual subject values. The 
planning and reporting of statistical analyses will be carried out as described in the CRO’s SOPs.
15.2 Subject Characteristics
A table will be provided with the following information:
• 
Number of subjects including screening failures (total population).
• 
Number of subjects included in each analysis population.
• 
Number of subjects withdrawn from the study and the reason for withdrawal.
Subject baseline characteristics will be summarized based on the Safety Population by treatment 
arm and dose level. Demographic information (age, height, weight, and body mass index) will 
be summarized using descriptive statistics. Gender, race, and disease stage will be summarized 
by counts and percentages.
Medical history data (coded using MedDRA) will be summarized by system organ class and 
preferred term. Concurrent medications will be recorded and coded using WHO-DDE and 
grouped by different classes, if applicable.
The MM-specific medical history will be summarized for the duration of disease, number of 
previous therapies, type of previous therapy, best response under respective drug treatment with 
corresponding date(s), and date(s) and type(s) of disease progression following any previous 
instances of previous myeloma-specific therapy.
15.3 ImmunogenicityAnalysis
One of the primary objectives will be to evaluate the immunogenicity of MOR03087 in the 
Evaluable Population and the Safety Population. This analysis will be based on both absolute 
(number and percentage of subjects who develop anti-MOR03087 antibodies) and 
semi-quantitative (anti-MOR03087 antibody titer determination of confirmed positive samples) 
assessments.
The number and percentage of subjects who develop confirmed anti-MOR03087 antibodies will 
be summarized descriptively by treatment arm and dose level. Exact 95% confidence intervals 
will be provided for the rate of subjects who developed anti-MOR03087 antibodies in the 
recommended dose group of each treatment arm.
Time to development of anti-MOR0387 antibodies will be summarized descriptively by 
treatment arm and dose level using Kaplan-Meier estimates for the median, 25% quartile, and 
75% quartile. If only a few subjects develop anti-MOR03087 antibodies, quantitative 
assessments will only be presented in listings. Otherwise, summary tables will also be provided.
Sponsor: MorphoSys AG
Confidential
Page 99 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
15.4 Efficacy Analysis
Overall response rate (PR or better), further tumor response rates (CR, sCR, PR, MR, VGPR), 
and SD rate will be summarized descriptively by visit (including Cycles 3+ and follow-up 
period) and by treatment arm and dose level.
The denominator for calculating the rates will be the total number of subjects within the 
corresponding population and treatment arm or dose level.
Exact 95% confidence intervals will be provided for the overall response rate in the 
recommended dose group of each treatment arm.
In addition, the best overall response will be determined for each subject.
Duration of response, time to progression, and progression-free survival will be summarized 
descriptively by treatment arm and dose level using Kaplan-Meier estimates for the median, 25% 
quartile, and 75% quartile. Kaplan-Meier plots will be provided for the recommended dose group 
of each treatment arm.
All efficacy analyses will be provided for the Efficacy Evaluable Population and the Safety 
Population.
15.5 Pharmacodynamic and Biomarker Analysis
Baseline values and absolute and percent changes from baseline by visit will be summarized 
descriptively by visit and by treatment arm and dose level for the following:
• 
Measurements of B, T, and NK cell populations
• 
CD16 expression on NK cells
• 
Result of flow cytometry of peripheral MM cells
• 
Serum and urine M-protein levels
• 
Serum FLC level and FLC ratio
The 95% confidence intervals will be provided for absolute and percent mean changes from 
baseline in the recommended dose group of each treatment arm.
Pharmacodynamics will also be assessed by evaluating bone marrow data for subjects with 
complete remission and subjects who provided an additional informed consent. Baseline values 
and absolute and percentage changes from baseline in histology, and immunophenotyping will 
be assessed. If there is a sufficient number of subjects who have bone marrow data after start of 
treatment, the bone marrow data will be summarized descriptively; otherwise the bone marrow 
data will only be included in listings.
Sponsor: MorphoSys AG
Confidential
Page 100 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
15.6 Pharmacokinetic Analysis
Concentration and pharmacokinetic data will be collected and analyzed for this study. 
Based on the data available, the following pharmacokinetic parameters will be computed:
Cmax
Maximum serum concentration observed
tmax
Time to maximum serum concentration observed
AUC0-t
Area under the concentration curve. The time curve from time zero 
(0) to the time that the last concentration above the lower limit of 
quantification (LLQ) is observed.
AUC0-^
Area under the concentration curve. The time curve from time zero 
(0) to infinity (ro), where infinity is computed from 
AUC0-t + [CtA z )]. Ct is calculated from the concentration at the last 
sampling time at which the sample is above LLQ.
'kz
Apparent terminal rate constant calculated from the regression 
analysis (slope) from the log-transformed measured concentrations 
on the terminal phase of the time-point concentration curve
t/
Apparent terminal half-life calculated from ln(2)A,z
CL
Total body clearance calculated for single or multiple doses: 
dose(s)/AUC0-ro
Vz
Apparent volume of distribution during the terminal phase, 
calculated from dose/(AUC0-^*^z )
More detailed information on the methodology of pharmacokinetic analysis will be supplied in 
the Statistical Analysis Plan.
15.7 Safety Analysis
15.7.1 Dose Limiting Toxicities and Maximum Tolerated Dose
One of the primary endpoints will be to determine the MTD or recommended dose and dosing 
regimen for MOR03087 with or without DEX and in combination with two standard IMiD 
therapies. This primary endpoint will be determined in the DLT Evaluable Population and will 
be based on a 4-week safety assessment period (one 28-day cycle).
Following completion of Parts A-C (dose escalation of MOR03087 alone and in combination 
with DEX using two dosing schedules), the MTD and/or recommended dose will be confirmed 
in a minimum of 6 subjects. Following completion of Parts D and E (dose escalation of 
MOR03087 in combination with POM+DEX and in combination with LEN+DEX), the MTD 
and/or recommended dose in each treatment arm will be confirmed in a minimum of 6 subjects.
The recommended doses for the confirmation cohorts will be determined after review of all 
available safety data from the corresponding dose-escalation portion of the study and based on 
the recommendation of the DMC. The recommended dose may be the MTD or a dose below the
Sponsor: MorphoSys AG
Confidential
Page 101 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
MTD. Additionally, the number and percentage of DLTs will be summarized descriptively for 
all subjects including subjects from the confirmation cohorts receiving the recommended dose 
and including further cycles of MOR03087 or cycles of combination therapy. For definition of 
DLT see Section 8.5.
15.7.2 Adverse Events
One of the primary endpoints will be to determine the incidence and severity of AEs. This 
primary endpoint will be determined based on the Safety Population.
An AE summary table will be presented showing the incidence and frequency of 
treatment-emergent AEs (TEAEs), SAEs, MOR03087-related TEAEs, MOR03087-related 
TEAEs by severity/toxicity (according to NCI CTCAE criteria), and infusion reactions. The 
incidence refers to the number and percentage of subjects and the frequency to the number and 
percentage of AEs. Exact 95% confidence intervals for the incidence rates will be included for 
the recommended dose group of each treatment arm.
The number and percent of subjects with one or more TEAEs will be summarized by treatment 
arm and dose level and by MedDRA system organ class and preferred term. Such summaries 
will be displayed for all TEAEs, TEAEs by maximum severity/toxicity, and TEAEs by 
relationship to IMP.
The sponsor will describe other AEs of special interest (i.e., infusion reactions, cytokine release, 
allergic reaction to MOR03087, second primary malignancies and DLTs), in addition to those 
reported as SAEs.
The number and percent of subjects with one or more pre-treatment AEs will be summarized by 
treatment arm and dose level and by system organ class and preferred term.
15.7.3 Clinical Laboratory Evaluations
The analysis of laboratory parameters will be presented separated into blood parameters 
(hematology, serum chemistry, endocrinology, coagulation) and urine parameters (urinalysis). 
All data will be listed.
For hematology and serum chemistry, the laboratory values will be transformed to SI values 
based on SI units to make laboratory parameters comparable between different local laboratories. 
The relevant reference ranges supplied by each laboratory will also be transformed to SI 
reference ranges for each laboratory.
Descriptive summaries of actual (absolute) values and changes from baseline values will be 
presented for hematology and serum chemistry by treatment arm and dose level for the Safety 
Population.
Each abnormal value will be flagged to show whether it is a value below or above the reference 
range. For the assessment of laboratory variables, five categories will be used that determine the 
investigator’s assessment of clinical relevance: ‘clin. rel., above’, ‘non-clin. rel., above’, 
‘within’, ‘non clin. rel., below’, ‘clin. rel., below’.
The assessment of laboratory variables will be tabulated by time point for each clinical laboratory 
analyte for the Safety Population by treatment arm and dose level (frequency tables). 
Additionally, for each laboratory parameter, shifts in assessments from baseline to all
Sponsor: MorphoSys AG
Confidential
Page 102 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
post-administration time points will be presented for the recommended dose groups of each 
treatment arm (shift tables).
Grades for a clinical laboratory analyte will be derived according to NCI CTCAE, version 4.0 
and used to present additional frequency and shift tables based on NCI CTCAE grades.
The assessment of categorical urinalysis variables will be tabulated by time point for each urine 
parameter for the Safety Population by part and dose level (frequency tables). Additionally, for 
each of these urine parameters, shifts in assessments from baseline to all post-administration 
time points will be presented for the recommended dose groups of each treatment arm (shift 
tables).
Laboratory values that are outside the reference range will also be flagged in the data listings, 
along with corresponding reference ranges.
15.7.4 Vital Signs
Descriptive summaries of actual values and changes from baseline will be calculated for vital 
signs. These summaries will be presented by part and dose level for the Safety Population and 
all time points. Each abnormal value will be flagged to show whether it is a value below or above 
the normal limit. The normal limits are detailed in Appendix 18.2).
15.7.5 Electrocardiograms
The summary ECG assessment (categories: <normal; abnormal clinically significant; abnormal 
not clinically significant) will be tabulated by time point for the Safety Population by treatment 
arm and dose level.
Each abnormal PR, QRS, and RR interval value will be flagged to show whether it is a value 
below or above the normal limit. The normal limits are detailed in Appendix 18.2).
Summary statistics for all time points will be displayed for QT and QTc correction methods, 
side-by-side, and by treatment arm and dose level. The Bazett’s corrections method for QTc will 
be applied as follows:
Q T
Bazett’s Correction (QTcb) 
QTcb = j R R
where: Relative Rate: RR = 60 / heart rate (HR)
Also, the number and percent of subjects in each treatment arm and dose level with QTc values 
above the normal limit (441-480 ms, 481-500 ms, or > 500 ms) and the number and percent of 
subjects in each treatment arm and dose level who experienced a change > 30 ms or a change 
> 60 ms will be presented by time point.
Sponsor: MorphoSys AG
Confidential
Page 103 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
15.7.6 Physical Examination
Baseline physical examination will be summarized by body system. New and worsening 
abnormal physical examination findings during the study will be entered as AEs and analyzed 
within the AE tables.
15.8 Other Variables
15.8.1 Pharmacogenetics and Genotyping
The frequency of genetic mutations will be summarized for different genetic markers by part and 
dose level. Subgroups based on different genetic patterns may be defined. The definition of 
subgroups will be dependent on the frequency of mutations and the genetic markers analyzed. 
Exploratory subgroup analysis may be used to understand possible pharmacokinetic and 
pharmacodynamic variability as a result of genetic heterogeneity in the study population.
15.8.2 Analysis of Quality of Life
Overall quality of life scores will be calculated for both quality of life questionnaires, the 
QLQ-C30 (version 3) and QLQ-MY20 questionnaire, by applying the commonly used scoring 
system.
The change from baseline in overall quality of life scores will be summarized descriptively by 
part and dose level.
15.9 Sample Size Determination
A 3 + 3 design will be used for the dose-escalation part of the study with confirmation cohorts 
of 6 subjects. At least 9 subjects will be analyzed in the recommended dose groups of each part: 
6 subjects from the confirmation cohort and at least 3 subjects from the dose-escalation cohort 
who receive the same dose and regimen and combination treatment (if applicable). This ensures 
that AEs that occur in a subject with a probability of 17% will be observed at least once within 
this group with a probability of 81%. If the AEs occur with a probability of 23%, then the 
probability of observing the AEs will increase to 90%.
15.10 Significance Level
Confidence intervals, both individual and simultaneous, will be at the 95% confidence level 
unless stated otherwise.
15.11 Procedures for Missing, Unused, and Spurious Data
Missing values will not be substituted by estimated values, but treated as missing in the statistical 
evaluation. All data from all subjects dosed in the study will be included in all listings, plots, 
summary tables, and statistical analyses when appropriate.
Sponsor: MorphoSys AG
Confidential
Page 104 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
15.12 Rules for Excluding Subjects from Analysis
All dosed subjects will be included in the analyses unless otherwise specified. The sponsor will 
make any decisions regarding whether any subjects will be excluded from the evaluations when 
the protocol violation is considered to have a negative impact on the scientific aspects and 
interpretation of the study results. If the subject has received any IMP, all available safety data 
will be used. The reason(s) for any exclusion will be described in the report.
15.13 Procedures for Reporting Deviations from Original Statistical Plan
Any deviations from the statistical analysis outlined in this protocol will be described, and 
reasons for the deviations listed, in the final clinical study report.
16 SPECIAL REQUIREMENTS AND PROCEDURES 
16.1 Institutional Review
Before starting this study, the protocol (authorized by the sponsor) will be submitted to the 
regulatory bodies/local health authorities (in accordance with local regulations) and to the 
IEC/IRB for evaluation. The protocol will also be signed by the principal investigators before 
submission to the IEC/IRB. The study will not start in the concerned Member State before the 
respective IEC/IRB gives written approval or a favorable opinion in accordance with ICH E6 
GCP and all applicable regulatory bodies/local health authorities give approval or a favorable 
opinion as required.
No substantial changes to the final approved (authorized) protocol will be initiated without the 
IEC’s/IRB’s prior written approval or favorable opinion of a written amendment, except when 
necessary to eliminate immediate hazards to the subjects or when the change involves only 
logistics or administration. The sponsor will authorize and the principal investigator(s) will sign 
the protocol amendment prior to submission to the IECs/IRBs. Protocol amendments should be 
submitted to the IEC/IRB without delay. Any significant deviation from the protocol when no 
approved amendment exists will be regarded as a protocol violation, and will be addressed as 
such during the reporting of the study.
16.2 Ethical Considerations
16.2.1 Regulatory and Ethical Compliance
This clinical study was designed and shall be conducted and reported in accordance with the 
protocol, with ICH E6 GCP, with applicable local regulations (including the national 
implementation of European Directive 2001/20/EC), and with the ethical principles laid down in 
the current version of the Declaration of Helsinki.
Sponsor: MorphoSys AG
Confidential
Page 105 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
16.2.2 Responsibilities of the Investigator and IRB/IEC
The protocol and the proposed subject information/informed consent form must be reviewed and 
approved by a properly constituted IRB/IEC before study start. A signed and dated statement 
that the protocol and informed consent form have been approved by the IRB/IEC/Regional 
Surveillance authority must be given to the sponsor before study initiation. Prior to study start, 
the investigator is required to sign a protocol signature page confirming his or her agreement to 
conduct the study in accordance with these documents and all of the instructions and procedures 
found in this protocol.
The IRB/IEC must be informed of all substantial subsequent protocol amendments and of 
reportable suspected unexpected serious adverse reactions (SUSARs) and other unexpected 
safety issues occurring during the study that are likely to affect the safety of the subjects or the 
conduct of the study. Approval for such changes must be transmitted in writing to the sponsor 
by the investigator.
The IRB/IEC should be provided with all updates of the IB. Also, written reports should be 
provided to the IRB/IEC annually or more frequently if requested on any change significantly 
affecting the conduct of the study and/or increasing risk to the subjects. A final report of study 
outcome, if required, should also be submitted to the IRB/IEC.
16.3 Investigator’s Responsibilities
16.3.1 Overall Responsibilities
The investigator is responsible for conducting the study in full accordance with the protocol and 
the current version of the Declaration of Helsinki, the Good Clinical Practice: Consolidated 
Guideline, approved by the ICH, and any applicable national and local laws and regulations. 
Information regarding any sites participating in this study that do not comply with these 
standards will be documented, and non-compliant sites should be excluded.
The investigator is accountable for the performance of the study (treatment of the subject and 
the documentation). If any responsibilities are delegated, the investigator should maintain a list 
of appropriately qualified persons to whom he or she has delegated significant study-related 
duties.
A “Delegation of Authority Log” will be filled in and signed by the responsible investigator. In 
accordance with this authority log, site staff (e.g., subinvestigators, nurses) will be authorized to 
perform study-related tasks and to enter specific data into the eCRF.
The CRO or designee is responsible for randomization, IRB/IEC submission, monitoring, 
biometry, data management, pharmacovigilance, and part of project management. The relevant 
submissions to the Competent Authorities are being handled by the sponsor in close cooperation 
with the CRO.
An independent DMC will be installed to review the data from each cohort of the study (dose 
escalation) and to make the decision whether to proceed to combination therapy arms, as well as 
review the data from each dose-escalation cohort in the combination therapy arms. The detailed 
composition, obligations, and procedures of the DMC will be presented in a separate charter
Sponsor: MorphoSys AG
Confidential
Page 106 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
provided by the sponsor. The investigator should not enroll any subject to the next cohort or next 
study part if the positive DMC decision is not available.
Most clinical laboratory tests will be done locally. Each investigator will receive detailed written 
instructions on the laboratory samples to be taken and laboratories to be used.
16.3.2 Subject Informed Consent
The investigator will obtain a freely given written consent from each subject after an appropriate 
explanation of the aims, methods, anticipated benefits, potential hazards and any other aspect of 
the study which is relevant to the subject's decision to participate. The informed consent form 
must be signed, with name and date and time noted by the subject, before the subject is exposed 
to any study-related procedure, including screening tests for eligibility.
The investigator will explain that the subjects are completely free to refuse to enter the study or 
to withdraw from it at any time, without any consequences for their further care and without the 
need to justify. The investigator will complete the informed consent section of the eCRF for each 
subject enrolled.
Each subject will be informed that his or her source records may be reviewed by the study 
monitor, a quality assurance auditor, or a health authority inspector (e.g., Paul-Ehrlich-Institut 
[PEI], Bundesamt fur Sicherheit im Gesundheitswesen (BASG)/Agentur fur Gesundheit und 
Ernahrungssicherheit [AGES]) in accordance with applicable regulations, and that these persons 
are bound by confidentiality obligations. The investigator will protect any personal information 
not related to the study and will assure that these persons are bound by confidentiality 
obligations.
Three separate informed consents will be set up: one for subjects entering dose-escalation in 
Parts A, B and C, one for the confirmation cohorts (Parts A, B and C), and one for the POM/LEN 
combination therapy arms (Parts D and E). The subjects must sign the correct version of the 
informed consent before being enrolled to the specific treatment arms.
In addition, for subjects who could potentially be enrolled to the LEN/MOR03087 combination 
therapy arm or POM/MOR03087 combination therapy arm, a signed LEN/POM information 
leaflet must also be available before enrollment to the combination treatment arm.
In addition, bone marrow samples on Day 29 (C2D1) may be taken from subjects only if specific 
consent for this assessment has been provided.
In addition to the standard study procedures, pharmacogenetic samples (e.g., for analysis of 
RNA, DNA) will be taken from subjects who agree to this procedure. A separate informed 
consent form will be signed for this. The procedure for obtaining this informed consent will be 
the same as for obtaining the study informed consent. Consent to donate these pharmacogenetic 
samples is completely voluntary and denying consent will have no effect on the subjects’ study 
participation.
16.3.3 Direct Access to Source Data/Documents
The monitors, auditors, authorized personnel of the sponsor, health authority inspectors or their 
agents, and authorized members of IECs/IRBs will be given direct access to source data and
Sponsor: MorphoSys AG
Confidential
Page 107 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
documentation (e.g., medical charts/records, laboratory results, printouts, videotapes, etc.) for 
source data verification, provided that subject confidentiality is maintained in accordance with 
local requirements.
16.3.4 Confidentiality Regarding Study Subjects
The investigators must assure that the privacy of the subjects, including their personal identity 
and all other personal medical information, will be maintained at all times. In eCRFs and other 
documents or image material submitted to the sponsor, subjects will not be identified by their 
names, but by an identification code (e.g., initials and study subject number).
Personal medical information may be scrutinized for the purpose of verifying data recorded in 
the eCRF. This may be done by the monitor, properly authorized persons on behalf of the 
sponsor, the quality assurance unit, or regulatory authorities. Personal medical information will 
always be treated as confidential.
16.3.5 Relevant Protocol Deviations
Deviations from the protocol should not occur. If deviations occur, the investigator should 
promptly inform the medical monitor and the implication of the deviation must be reviewed and 
discussed. Any deviation must be documented, stating the reason and date, the action taken, and 
the impact on the subject and/or the study. The documentation must be kept in the investigator’s 
study file and the sponsor’s file.
Examples of relevant protocol deviations that will be addressed (but not limited to these) are as 
follows:
• 
Subjects who enter the study even though they did not satisfy the entry criteria
• 
Subjects who develop withdrawal criteria during the study
• 
Subjects who receive the wrong treatment or incorrect dose
• 
Subjects who receive an excluded concomitant treatment (e.g., another monoclonal 
antibody).
• 
Non-compliance with protocol setting that puts the safety of the subject or the scientific 
validity of the study at risk
In case of any major protocol deviations or violations, the investigator will decide on the further 
participation of the subject in this study, after having discussed all relevant aspects with the 
medical monitor. The Sponsor may, however, request the exclusion of such a subject from further 
participation in the study.
A list of all included subjects with all deviations from the intended study procedures and other 
criteria that may affect the subject's validity for statistical analysis will be prepared upon clinical 
completion of the study. This will then be discussed by a panel consisting of the clinical project 
manager, a medical expert of the sponsor, the data manager, and the study biometrician. This 
panel will decide upon the membership of the subject in the subject populations for statistical 
analysis.
Sponsor: MorphoSys AG
Confidential
Page 108 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
16.4 Study Monitoring
Study monitoring will be performed in accordance with ICH E6 GCP, the CRO’s SOPs, the 
protocol, and applicable local regulations.
16.5 Audit and Inspection
According to ICH E6 GCP, the sponsor or regulatory authorities may audit the investigational 
sites. The sponsor’s Quality Assurance Unit, independent of the Clinical Research and 
Development Department, is responsible for auditing the study. The investigator must accept 
such audits by the sponsor’s Quality Assurance Unit and ensure access to source documentation.
The investigator must accept that regulatory authorities may conduct an inspection to verify 
compliance of the study with GCP. If informed that a regulatory inspection will take place, the 
investigator must inform the sponsor without delay.
16.6 Insurance
This study is covered under the sponsor’s Liability Insurance Policy covering damage to subjects 
according to the legal requirements of each country. A copy of the Certificate of Insurance and/or 
an information leaflet containing essential information about the insurance coverage will be 
provided to the investigator.
The investigator must inform the subjects accordingly and must also point out that the subjects 
are allowed to undergo other medical treatment (except in an emergency) only with the 
investigator’s prior approval or to receive additional medication only with the investigator’s prior 
approval.
16.7 Study Report and Publication Policy
The results of this clinical study will be documented in an integrated clinical study report 
according to ICH E3 Note for Guidance on Structure and Content of Clinical Study Reports, 
which will be signed by the authors, sponsor, and coordinating investigator. Reports will also be 
generated for IEC/IRB review and for regulatory reporting as required.
Any presentation or publication of data from this study will be intended as a joint publication by 
the investigator(s)/appropriate site personnel and appropriate sponsor personnel. Authorship will 
follow the International Committee of Medical Journal Editors (ICMJE) Uniform Requirements 
for Manuscripts Submitted to Biomedical Journals and will be defined prior to the first 
publication. All other investigators, co-investigators, and study coordinators will be listed in an 
acknowledgement.
For multicentre studies, it is mandatory that the first publication be based on data from all sites, 
and that data are analyzed and submitted as stipulated in the protocol by a statistician assigned 
by the sponsor. The authors have the final responsibility for the decision to submit their 
manuscript and shall be given full access to the data resulting from the study, subject to the 
provisions of this section. The authors shall coordinate any intended publication of study results 
with the sponsor, to enable the sponsor to ensure that results are presented in a responsible and
Sponsor: MorphoSys AG
Confidential
Page 109 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
coherent manner. The sponsor reserves the right to review all manuscripts and abstracts before 
their submission for publication or presentation, and the authors shall consider all comments and 
reviews of the sponsor and may not unduly disregard such comments and reviews of the sponsor. 
With respect to the review process, the authors shall send the relevant manuscript to the sponsor 
at least 60 days before submission or presentation of the data. This is not intended to restrict or 
hinder publication or presentation, but to allow the sponsor to protect the confidentiality of 
information and to provide comments that may not yet be available to the investigator. The 
sponsor has the right to have removed any confidential information from the manuscripts. In the 
rare event that such publication would affect the patentability of any invention to which the 
sponsor has rights, the sponsor has the right to request, and the authors shall grant, an additional 
delay to the proposed publication of no more than 90 days so as to allow the sponsor to protect 
its intellectual property rights.
The results of the study may be used by MorphoSys AG for the purposes of national and 
international registration, publication, and information for medical professionals. If necessary, 
the authorities will be notified of the investigators’ names, addresses, qualifications, and extent 
of involvement.
Sponsor: MorphoSys AG
Confidential
Page 110 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
17 REFERENCES
Alexanian R, Haut A, Khan AU, Lane M, McKelvey EM, Migliore PJ, Stuckey WJ Jr, Wilson 
HE. Treatment for multiple myeloma. Combination chemotherapy with different melphalan dose 
regimens. JAMA. 1969 Jun 2;208(9):1680-5.
Alexanian R, Dimopoulos MA, Delasalle K, Barlogie B. Primary dexamethasone treatment of 
multiple myeloma. Blood. 1992 Aug 15;80(4):887-90.
Blade J, Samson D, Reece D, Apperley J, Bjorkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath 
S, Vesole D. Criteria for evaluating disease response and progression in subjects with multiple 
myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Br J Haematol 
1998 Sep;102(5): 1115-1123.
Chanan-Khan AA, Giralt S. Importance of achieving a complete response in multiple myeloma, 
and the impact of novel agents. J Clin Oncol 2010 May 20;28(15):2612-2624.
Chauhan D, Auclair D, Robinson EK, Hideshima T, Li G, Podar K, Gupta D, Richardson P, 
Schlossman RL, Krett N, Chen LB, Munshi NC, Anderson KC. Identification of genes regulated 
by dexamethasone in multiple myeloma cells using oligonucleotide arrays. Oncogene 
2002 Feb 21;21(9): 1346-1358.
Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos 
M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M,Crowley J, Belch A, Boccadaro M, 
Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, 
Powles R, Richardson P, Shimizu K,Tosi P, Morgan G, Rajkumar SV; International Myeloma 
Working Group.. International uniform response criteria for multiple myeloma. Leukemia. 
2006 Sep;20(9):1467-1473. 
Erratum 
in: 
Leukemia. 
2007 May;21(5):1134 
and
2006 Dec;20(12):2220.
Durie BG, Salmon SE. A clinical staging system for multiple myeloma. Correlation of measured 
myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer 
1975 Sep; 36(3): 842-854.
Greipp PR, San Miguel J, Durie BG, Crowley JJ, Barlogie B, Blade J, Boccadoro M, Child JA, 
Avet-Loiseau H, Kyle RA, Lahuerta JJ, Ludwig H, Morgan G, Powles R, Shimizu K, Shustik C, 
Sonneveld P, Tosi P, Turesson I, Westin J. International staging system for multiple myeloma. J 
Clin Oncol 2005 May; 23(15):3412-20.
Imnovid®. Summary of Product Characteristics.
Jagannath S, Kyle RA, Palumbo A, Siegel DS, Cunningham S, Berenson J. The current status 
and future of multiple myeloma in the clinic. 
Clin Lymphoma Myeloma Leuk 
2010 Feb;10(1):28-43.
Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response 
assessment of multiple myeloma. Leukemia 2009 Jan;23(1):3-9.
Kyle RA, Rajkumar SV. Treatment of multiple myeloma: a comprehensive review. Clin 
Lymphoma Myeloma 2009 Aug;9(4):278-88.
Sponsor: MorphoSys AG
Confidential
Page 111 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Laubach JP, Mahindra A, Mitsiades CS, Schlossman RL, Munshi NC, Ghobrial IM, Carreau N, 
Hideshima T, Anderson KC, Richardson PG. The use of novel agents in the treatment of relapsed 
and refractory multiple myeloma. Leukemia 2009 Dec;23(12):2222-32.
Mass RE. A comparison of the effect of prednisone and a placebo in the treatment of multiple 
myeloma. Cancer Chemother Rep. 1962 Feb;16:257-9.
Minnema MC, van der Spek E, van de Donk NW, Lokhorst HM. New developments in the 
treatment of patients with multiple myeloma. Neth J Med. 2010 Jan;68(1):24-32.
Revlimid®. Summary of Product Characteristics.
Sprangers MAG, Cull A, Groenvold M, Bjordal K, Blazeby J, Aaronson NK. The European 
Organization for Research and Treatment of Cancer approach to developing questionnaire 
modules: an update and overview. EORTC Quality of Life Study Group. Qual Life Res. 
1998 May;7(4):291-300.
Stead ML, Brown JM, Velikova G, Kaasa S, Wisl0ff F, Child JA, Hippe E, Hjorth M, Sezer O, 
Selby P. Development of an EORTC questionnaire module to be used in health-related 
quality-of-life assessment for subjects with multiple myeloma. European Organization for 
Research and Treatment of Cancer Study Group on Quality of Life. Br J Haematol 1999 
Mar;104(3):605-11.
Sponsor: MorphoSys AG
Confidential
Page 112 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18 APPENDICES
18.1 Information on Investigational and Registered Products
The Investigator’s Brochure for MOR03087, and SmPCs for dexamethasone (sample), 
lenalidomide, and pomalidomide will be supplied to the sites.
Sponsor: MorphoSys AG
Confidential
Page 113 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.2 Normal Limits for Vital Signs, Weight, Height, and ECG Intervals
Criteria for normal limits are provided for vital signs, weight (Table 12) and for ECG parameters 
(Table 13).
Table 12 
Criteria for Normal Limits for Vital Signs and Weight
Weight and Vital Signs Parameter
Normal Limits
Low
High
Systolic blood pressure (mmHg)
85
139
Diastolic blood pressure (mmHg)
60
89
Pulse rate (bpm)
60
100
Respiration rate (rpm)
12
22
Body temperature (°C)
36.4
37.7
Oxygen saturation (%)
93
100
Body weight (kg)a
41
113
Body mass index (kg/m2)b
18.5
24.9
a 
Changes in body weight are evaluated by the investigator (without taking height into account) since BMI is
not collected on the eCRF.
b 
BMI is calculated and analyzed retrospectively by the sponsor, at which time height is taken into account.
Table 13 
Criteria for Normal Limits for ECGs
ECG Variable
Normal Lii 
Low
mits (msec)
High
PR interval
120
200
QRS interval
50
100
RR interval
600
1000
QT interval3 
(gender not specified)
-
<440
QTc interval 
(gender not specified)
-
<440
a No lower boundary set for QTc.
Sponsor: MorphoSys AG
Confidential
Page 114 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.3 Response Criteria for Multiple Myeloma
The tumor response criteria for multiple myeloma in this study are those defined in Table 14 
below. All of them are based on the International Myeloma Working Group Uniform Response 
Criteria (Durie 2006), except for MR, which is based on the adopted EBMT criteria 
(Blade 1998).
Table 14
Response Criteria for Multiple Myeloma
Response
subcategory
Criteriaa
sCR
• CR as defined below plus 
Normal FLC ratio and
Absence of clonal cells in bone marrowb by immunohistochemistry or 
immunofluorescence0
CR
• Negative immunofixation on the serum and urine and
• Disappearance of any soft tissue plasmacytomas and
• < 5% plasma cells in bone marrowb
VGPR
• Serum and urine M-protein detectable by immunofixation but not electrophoresis 
or
• > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 hours
PR
• > 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein 
by > 90% or to < 200 mg/24 hours
• If the serum and urine M-protein are unmeasurable, a > 50% decrease in the 
difference between levels of involved and uninvolved free-light-chains instead of 
the M-protein criteria
• In addition to the above-listed criteria, if present at baseline, a > 50% reduction in 
the size of soft tissue plasmacytomas is also required
MRde
• 25-49% reduction in level of serum M-protein
• 50-89% reduction in 24-hour urinary M-protein, which still exceeds
200 mg/24 hours If present at baseline, 25-49% reduction in the size of soft tissue 
plasmacytomas (by radiography or clinical examination)
• No increase in the size or number of lytic bone lesions (development of a 
compression fracture does not exclude response)
SDf
• Not meeting criteria for CR, VGPR, PR, MR, or PD
PD
NOTE: Requires any one or more of the following:
Increase of > 25% from nadir in
• Serum M-component and/or (absolute increase must be > 0.5 g/dL)g
• Urine M-component and/or (absolute increase must be > 200 mg/24 hours)
• Only in patients without measurable serum and urine M-protein levels: the 
difference between involved and uninvolved FLC levels. Absolute increase must 
be > 10 mg/dL.
• Bone marrow plasma cell percentage: absolute % must be > 10%h
• Definite development of new bone lesions or soft tissue plasmacytomas or definite 
increase in the size of existing bone lesions or soft tissue plasmacytomas
• Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or
2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
Sponsor: MorphoSys AG 
Confidential 
Page 115 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Abbreviations: CR = complete response; FLC = free light chain; MR = minimal response; PD = progressive 
disease; PR = partial response; SD = stable disease; VGPR = very good partial response 
a All response categories require two consecutive assessments made at any time before the institution of any 
new therapy; all categories also require no known evidence of progressive or new bone lesions if radiographic 
studies were performed. Radiographic studies are not required to satisfy these response requirements. 
b Confirmation with repeat bone marrow biopsy not needed.
c Presence/absence of clonal cells is based upon the kA ratio. An abnormal kA ratio by immunohistochemistry 
and/or immunofluorescence requires a minimum of 100 plasma cells for analysis. An abnormal ratio 
reflecting presence of an abnormal clone is kA of >4:1 or <1:2. 
d MR also includes subjects in whom some, but not all, the criteria for PR are fulfilled, provided the remaining 
criteria satisfy the requirements for MR.
e The response criterion MR will not apply to subjects who present with serum FLCs only. 
f Per the International Myeloma Working Group Uniform Response Criteria (Durie 2006), stable disease is not 
recommended for use as an indicator of response; stability of disease is best described by providing the time 
to progression estimates.
g For progressive disease, serum M-component increases of > 1 g/dL are sufficient to define relapse if starting 
M-component is > 5 g/dL.
h Relapse from CR has the 5% cut-off versus 10% for other categories of relapse.
Sponsor: MorphoSys AG
Confidential
Page 116 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.4 New York Heart Association Functional Classification
The NYHA criteria for classifying the extent of cardiac failure are presented in Table 15
Table 15
Criteria for NYHA Functional Classification
NYHA Class
Criteria
I
No symptoms and no limitation in ordinary physical activity. Shortness of breath 
when walking, stair climbing, etc.
II
Mild symptoms (mild shortness of breath and/or angina pain) and slight limitation 
during ordinary activity.
III
Marked limitation in activity due to symptoms, even during less-than-ordinary 
activity (e.g., walking short distances, approximately > 20 -  100 meters). 
Comfortable only at rest.
IV
Severe limitations. Experiences symptoms even while at rest, mostly bedbound 
patients.
Abbreviation: NYHA = New York Heart Association
Sponsor: MorphoSys AG
Confidential
Page 117 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.5 Karnofsky Performance Status
The Karnofsky criteria for assessing performance status are presented in Table 16.
Table 16 
Criteria for Karnofsky Performance Status
Score (Percent)
Criteria
100
Normal, no complaints, no evidence of disease
90
Able to carry on normal activity; minor signs or symptoms of disease
80
Normal activity with effort; some signs or symptoms of disease
70
Cares for self, unable to carry on normal activity or to do active work
60
Requires occasional assistance, but is able to care for most of his/her needs
50
Requires considerable assistance and frequent medical care
40
Disabled, requires special care and assistance
30
Severely disabled, hospitalization indicated; death not imminent
20
Very sick, hospitalization indicated; death not imminent
10
Moribund, fatal processes progressing rapidly
0
Dead
Sponsor: MorphoSys AG
Confidential
Page 118 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.6 International Staging System (ISS) Criteria and Durie-Salmon Staging 
Criteria
Details of multiple myeloma staging are provided according to the International Staging System 
(Table 17) and the Durie-Salmon criteria (Table 18). Staging should be performed at the time of 
screening.
Table 17 
Criteria for International Staging System (ISS)
Stage I
P2-microglobulin (P2M) < 3.5 mg/L, albumin > 3.5 g/dL
Stage II
P2M < 3.5 mg/L and albumin < 3.5 g/dL; or P2M 3.5—5.5 mg/L irrespective of the 
serum albumin
Stage III
P2M > 5.5 mg/L
Greipp PR, San Miguel J, Durie BG, Crowley JJ, Barlogie B, Blade J, Boccadoro M, Child JA, Avet-Loiseau H, 
Kyle RA, Lahuerta JJ, Ludwig H, Morgan G, Powles R, Shimizu K, Shustik C, Sonneveld P, Tosi P, Turesson I, 
Westin J. International staging system for multiple myeloma. J Clin Oncol 2005 23:3412-20.
Table 18 
Criteria for Durie-Salmon Staging
Stage
Criteria
Measured 
Myeloma Cell 
Massa
Stage I
(low cell mass)
All of the following:
• 
Hemoglobin value >10 g/dL
• 
Serum calcium value normal or <10.5 mg/dL
• 
Bone x-ray, normal bone structure (scale 0), or 
solitary bone plasmacytoma only
• 
Low M-component production rates IgG value 
<5 g/dL; IgA value <3 g/dL
• 
Urine light chain M-component on 
electrophoresis <4 g/24h
600 billion
Stage II
(intermediate cell mass)
Fitting neither Stage I nor Stage III
600 to 1,200 billion
Stage III
(high cell mass)
One or more of the following:
• 
Hemoglobin value <8.5 g/dL
• 
Serum calcium value >12 mg/dL
• 
Advanced lytic bone lesions (scale 3)
• 
High M-component production rates IgG value 
>7 g/dL IgA value >5 g/dL
• 
Bence Jones protein >12 g/24h
>1,200 billion
Subclassification
(either A or B)
• 
A: relatively normal renal function (serum 
creatinine value) <2.0 mg/dL
• 
B: abnormal renal function (serum creatinine 
value) >2.0 mg/dL
Examples: Stage IA  (low  cell m ass w ith norm al renal function) 
Stage IIIB (high cell mass w ith abnorm al renal function
a Myeloma cells in whole body, in billions/m2
Sponsor: MorphoSys AG
Confidential
Page 119 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Durie BG, Salmon SE. A clinical staging system for multiple myeloma. Correlation of measured myeloma cell 
mass with presenting clinical features, response to treatment, and survival. Cancer 1975; 36: 842-854.
18.7 Equivalent Doses for Corticosteroids
Table 19 presents a summary of corticosteroid doses that are equivalent to standard 
methylprednisolone doses.
Table 19 
Equivalent Doses for Corticosteroids
Name (INN)
Example
Equivalent doses for 
80 -  100 -  120 mg 
methylprednisolone
Potency
Hydrocortisone
Hydrocortone®
400 -  500 -  600 mg
1
Prednisone
Decortin®
100 -  125 -  150 mg
4
Prednisolone
Decortin® H
100 -  125 -  150 mg
4
Methylprednisolone
Urbason®
80 -  100 -  120 mg
5
Dexamethasone
Fortecortin®
14 -  16 -  20 mg
30
Sponsor: MorphoSys AG
Confidential
Page 120 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.8 Pregnancy Prevention Risk Minimization Plans
18.8.1 Lenalidomide Pregnancy Prevention Risk Minimization Plan
18.8.1.1 Lenalidomide Pregnancy Risk Minimization Plan for Clinical Trials
Appendix 18.8.1 applies to all subjects receiving LEN therapy. The following Pregnancy risk 
minimization plan documents are included in this appendix:
1) Lenalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth 
Control Methods (Appendix 18.8.1.2);
2) Lenalidomide Education and Counseling Guidance Document (Appendix 18.8.1.3);
3) Lenalidomide Information Sheet (Appendix 18.8.1.4).
1. The Lenalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable 
Birth Control Methods document (Appendix 18.8.1.2) provides the following information:
• 
Potential risks to the fetus associated with LEN exposure
• 
Definition of Female of Childbearing Potential
• 
Pregnancy testing requirements for subjects receiving LEN who are females of 
childbearing potential
• 
Acceptable birth control methods for both female of childbearing potential and male 
subjects receiving LEN in the study
• 
Requirements for counseling of all study subjects receiving LEN about pregnancy 
precautions and the potential risks of fetal exposure to LEN
2. The Lenalidomide Education and Counseling Guidance Document (Appendix 18.8.1.3) 
must be completed and signed by either a trained counselor or the Investigator at the 
participating clinical center prior to each dispensing of LEN study treatment. A copy of 
this document must be maintained in the subject records.
3. The Lenalidomide Information Sheet (Appendix 18.8.1.4) will be given to each subject 
receiving LEN study therapy. The subject must read this document prior to starting 
LEN study treatment and each time they receive a new supply of study drug.
Sponsor: MorphoSys AG
Confidential
Page 121 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.8.1.2 Lenalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and 
Acceptable Birth Control Methods
Risks Associated with Pregnancy
LEN is structurally related to thalidomide. Thalidomide is a known human teratogenic active 
substance that causes severe life-threatening birth defects. An embryofetal development study 
in animals indicates that LEN produced malformations in the offspring of female monkeys who 
received the drug during pregnancy. The teratogenic effect of LEN in humans cannot be ruled 
out. Therefore, a risk minimization plan to prevent pregnancy must be observed.
Criteria for females of childbearing potential (FCBP)
This protocol defines a female of childbearing potential as a sexually mature woman who:
1) has not undergone a hysterectomy or bilateral oophorectomy or
2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule 
out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time 
in the preceding 24 consecutive months).
Counseling
For a female of childbearing potential, LEN is contraindicated unless all of the following are 
met (i.e., all females of childbearing potential must be counseled concerning the following 
risks and requirements prior to the start of LEN study therapy):
• 
She understands the potential teratogenic risk to the unborn child
• 
She understands the need for effective contraception, without interruption, 4 weeks 
before starting study treatment, throughout the entire duration of study treatment, 
dose interruption and 28 days after the end of study treatment
• 
She should be capable of complying with effective contraceptive measures
• 
She is informed and understands the potential consequences of pregnancy and the 
need to notify her study doctor immediately if there is a risk of pregnancy
• 
She understands the need to commence the study treatment as soon as study drug is 
dispensed following a negative pregnancy test
• 
She understands the need and accepts to undergo pregnancy testing based on the 
frequency outlined in this protocol (Appendix 18.8.1.2)
• 
She acknowledges that she understands the hazards and necessary precautions 
associated with the use of LEN
The investigator must ensure that for females of childbearing potential:
• 
Complies with the conditions for pregnancy risk management, including 
confirmation that she has an adequate level of understanding
• 
Acknowledge the aforementioned requirements
Sponsor: MorphoSys AG
Confidential
Page 122 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
For a female NOT of childbearing potential, LEN is contraindicated unless all of the following 
are met (i.e., all females NOT of childbearing potential must be counseled concerning the 
following risks and requirements prior to the start of LEN study therapy):
• 
She acknowledges that she understands the hazards and necessary precautions 
associated with the use of LEN
Traces of LEN have been found in semen. Male subjects taking LEN must meet the following 
conditions (i.e., all males must be counseled concerning the following risks and requirements 
prior to the start of LEN study therapy):
• 
Understand the potential teratogenic risk if engaged in sexual activity with a 
pregnant female or a female of childbearing potential
• 
Understand the need for the use of a condom even if he has had a vasectomy, if 
engaged in sexual activity with a pregnant female or a female of childbearing 
potential.
Contraception
Females of childbearing potential (FCBP) enrolled in this protocol must agree to use two 
reliable forms of contraception simultaneously or to practice complete abstinence from 
heterosexual contact during the following time periods related to this study:
1) for at least 28 days before starting study drug;
2) while participating in the study;
3) dose interruptions; and
4) for at least 28 days after study treatment discontinuation.
The two methods of reliable contraception must include one highly effective method and one 
additional effective (barrier) method. FCBP must be referred to a qualified provider of 
contraceptive methods if needed. The following are examples of highly effective and additional 
effective methods of contraception:
• 
Highly effective methods:
-  
Intrauterine device (IUD)
-  Hormonal (birth control pills, injections, implants)
-  
Tubal ligation
-  Partner’s vasectomy
• 
Additional effective methods:
-  Male condom
-  Diaphragm
-  
Cervical Cap
Because of the increased risk of venous thromboembolism in patients with multiple myeloma 
taking LEN and DEX, combined oral contraceptive pills are not recommended. If a subject is
Sponsor: MorphoSys AG
Confidential
Page 123 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
currently using combined oral contraception the subject should switch to one of the effective 
method listed above. The risk of venous thromboembolism continues for 4 to 6 weeks after 
discontinuing combined oral contraception. The efficacy of contraceptive steroids may be 
reduced during co-treatment with DEX.
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk 
of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics 
should be considered particularly in subjects with neutropenia.
Pregnancy testing
Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be 
performed for females of childbearing potential, including females of childbearing potential 
who commit to complete abstinence, as outlined below.
Before starting study drug
Female Subjects:
FCBP must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to 
starting study drug. The first pregnancy test must be performed within 10 to 14 days prior to 
the start of study drug and the second pregnancy test must be performed within 24 hours prior 
to the start of study drug. The subject may not receive study drug until the study doctor has 
verified that the results of these pregnancy tests are negative.
Male Subjects:
Must practice complete abstinence or agree to use a condom during sexual contact with a 
pregnant female or a female of childbearing potential while participating in the study, during 
dose interruptions and for at least 28 days following study drug discontinuation, even if he has 
undergone a successful vasectomy.
During study participation and for 28 days following study drug discontinuation
Female Subjects:
• 
FCBP with regular or no menstrual cycles must agree to have pregnancy tests 
weekly for the first 28 days of study participation and then every 28 days while on 
study, at study discontinuation, and at day 28 following study drug discontinuation. 
If menstrual cycles are irregular, the pregnancy testing must occur weekly for the 
first 28 days and then every 14 days while on study, at study discontinuation, and at 
days 14 and 28 following study drug discontinuation.
• 
At each visit, the Investigator must confirm with the FCBP that she is continuing to 
use two reliable methods of birth control.
• 
Counseling about pregnancy precautions and the potential risks of fetal exposure 
must be conducted at a minimum of every 28 days.
• 
If pregnancy or a positive pregnancy test does occur in a study subject, study drug 
must be immediately discontinued.
Sponsor: MorphoSys AG
Confidential
Page 124 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Pregnancy testing and counseling must be performed if a subject misses her period 
or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment 
must be discontinued during this evaluation.
• 
Females must agree to abstain from breastfeeding during study participation and for 
at least 28 days after study drug discontinuation.
Male Subjects:
• 
Counseling about the requirement for complete abstinence or condom use during 
sexual contact with a pregnant female or a female of childbearing potential and the 
potential risks of fetal exposure to LEN must be conducted at a minimum of every 
28 days.
• 
If pregnancy or a positive pregnancy test does occur in the partner of a male study 
subject during study participation, the investigator must be notified immediately.
Additional precautions
• 
Subjects should be instructed never to give this medicinal product to another person 
and to return any unused capsules to the study doctor at the end of treatment.
• 
Female subjects should not donate blood during therapy and for at least 28 days 
following discontinuation of study drug.
• 
Male subjects should not donate blood, semen or sperm during therapy or for at 
least 28 days following discontinuation of study drug.
• 
Only enough study drug for one cycle of therapy may be dispensed with each cycle 
of therapy.
Sponsor: MorphoSys AG
Confidential
Page 125 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.8.1.3 Lenalidomide Education and Counselling Guidance Document
To be completed prior to each dispensing of study drug.
Protocol Number:________________________________________________
Subject Name (Print):___________________ D O B:_____ /_____ /_____ (mm/dd/yyyy)
(Check the appropriate box to indicate risk category)
Female: □
If female, check one:
□ FCBP (Female of childbearing potential): sexually mature female who: 1) has not 
undergone a hysterectomy (the surgical removal of the uterus) or bilateral 
oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally 
postmenopausal (amenorrhea following cancer therapy does not rule out 
childbearing potential) for at least 24 consecutive months (i.e., has had menses at 
any time during the preceding 24 consecutive months)
□ NOT FCBP
Male: 
□
Do Not Dispense study drug if:
• 
The subject is pregnant.
• 
No pregnancy tests were conducted for a FCBP.
• 
The subject states she did not use TWO reliable methods of birth control 
(unless practicing complete abstinence of heterosexual contact) [at least 
28 days prior to therapy, during therapy and during dose interruption].
FCBP:
1. I verified that the required pregnancy tests performed are negative.
2. I counseled FCBP regarding the following:
• 
Potential risk of fetal exposure to lenalidomide: If lenalidomide is taken during 
pregnancy, it may cause birth defects or death to any unborn baby. Females are 
advised to avoid pregnancy while taking lenalidomide. The teratogenic potential of 
lenalidomide in humans cannot be ruled out. FCBP must agree not to become 
pregnant while taking lenalidomide.
• 
Using TWO reliable methods of birth control at the same time or complete 
abstinence from heterosexual contact [at least 28 days prior to therapy, during 
therapy, during dose interruption and 28 days after discontinuation of study drug]. •
• 
That even if she has amenorrhea she must comply with advice on contraception
Sponsor: MorphoSys AG
Confidential
Page 126 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Use of one highly effective method and one additional method of birth control AT 
THE SAME TIME. The following are examples of highly effective and additional 
effective methods of contraception:
-  Highly effective methods:
o 
Intrauterine device (IUD)
o 
Hormonal (birth control pills, injections, implants) 
o 
Tubal ligation 
o 
Partner’s vasectomy
-  
Additional effective methods: 
o Male condom
o 
Diaphragm 
o 
Cervical Cap
• 
Pregnancy tests before and during treatment, even if the subject agrees not to have 
reproductive heterosexual contact. Two pregnancy tests will be performed prior to 
receiving study drug, one within 10 to 14 days and the second within 24 hours of 
the start of study drug.
• 
Frequency of pregnancy tests to be done:
-  Every week during the first 28 days of this study and a pregnancy test every 
28 days during the subject’s participation in this study if menstrual cycles are 
regular or every 14 days if cycles are irregular.
-  
If the subject missed a period or has unusual menstrual bleeding.
-  When the subject is discontinued from the study and at day 28 after study drug 
discontinuation if menstrual cycles are regular. If menstrual cycles are irregular, 
pregnancy tests will be done at discontinuation from the study and at days 14 
and 28 after study drug discontinuation.
• 
Stop taking study drug immediately in the event of becoming pregnant and to call 
their study doctor as soon as possible.
• 
NEVER share study drug with anyone else.
• 
Do not donate blood while taking study drug and for 28 days after stopping study 
drug.
• 
Do not breastfeed a baby while participating in this study and for at least 28 days 
after study drug discontinuation.
• 
Do not break, chew, or open study drug capsules.
• 
Return unused study drug to the study doctor.
3. Provide Lenalidomide Information Sheet to the subject.
Sponsor: MorphoSys AG
Confidential
Page 127 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
FEMALE NOT OF CHILDBEARING POTENTIAL (NATURAL MENOPAUSE FOR 
AT LEAST 24 CONSECUTIVE MONTHS, A HYSTERECTOMY, OR BILATERAL 
OOPHORECTOMY):
1. I counseled the female NOT of child bearing potential regarding the following:
• 
Potential risks of fetal exposure to lenalidomide (Refer to item #2 in FCBP)
• 
NEVER share study drug with anyone else.
• 
Do not donate blood while taking study drug and for 28 days after stopping study 
drug.
• 
Do not break, chew, or open study drug capsules.
• 
Return unused study drug capsules to the study doctor.
2. Provide Lenalidomide Information Sheet to the subject.
MALE:
1. I counseled the Male subject regarding the following:
• 
Potential risks of fetal exposure to lenalidomide (Refer to item #2 in FCBP).
• 
To engage in complete abstinence or use a condom when engaging in sexual contact 
(including those who have had a vasectomy) with a pregnant female or a female of 
childbearing potential, while taking study drug, during dose interruptions and for 
28 days after stopping study drug.
• 
Males should notify their study doctor when their female partner becomes pregnant 
and female partners of males taking study drug should be advised to call their 
healthcare provider immediately if they get pregnant.
• 
NEVER share study drug with anyone else.
• 
Do not donate blood, semen or sperm while taking study drug and for 28 days after 
stopping study drug.
• 
Do not break, chew, or open study drug capsules.
• 
Return unused study drug capsules to the study doctor.
2. Provide Lenalidomide Information Sheet to the subject.
Investigator/Counselor Name (Print): 
(circle applicable)
Investigator/Counselor Signature:_________________________ 
D ate:_____ /_____ /_____
(circle applicable)
**Maintain a copy of the Education and Counseling Guidance Document in the subject records.**
Sponsor: MorphoSys AG
Confidential
Page 128 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.8.1.4 Lenalidomide Information Sheet
FOR SUBJECTS ENROLLED IN CLINICAL RESEARCH STUDIES
Please read this Lenalidomide Information Sheet before you start taking study drug and each 
time you get a new supply. This Lenalidomide Information Sheet does not take the place of an 
informed consent to participate in clinical research or talking to your study doctor or healthcare 
provider about your medical condition or your treatment.
What is the most important information I  should know about lenalidomide?
1. 
Lenalidomide may cause birth defects (deformed babies) or death of an unborn 
baby. Lenalidomide is similar to the medicine thalidomide. It is known that 
thalidomide causes life-threatening birth defects. Lenalidomide has not been tested in 
pregnant women but may also cause birth defects. Findings from a monkey study 
indicate that lenalidomide caused birth defects in the offspring of female monkeys who 
received the drug during pregnancy.
If you are a female who is able to become pregnant:
• 
Do not take study drug if you are pregnant or plan to become pregnant
• 
You must practice complete abstinence or use two reliable, separate forms of 
effective birth control at the same time:
-  
for 28 days before starting study drug
-  while taking study drug
-  
during dose interruptions of study drug
-  
for 28 days after stopping study drug
• 
You must have pregnancy testing done at the following times:
-  within 10 to 14 days and again 24 hours prior to the first dose of study drug
-  weekly for the first 28 days
-  
every 28 days after the first month or every 14 days if you have irregular 
menstrual periods
-  
if you miss your period or have unusual menstrual bleeding
-  
28 days after the last dose of study drug (14 and 28 days after the last dose if 
menstrual periods are irregular)
• 
Stop taking study drug if you become pregnant during treatment
-  
If you suspect you are pregnant at any time during the study, you must stop 
study drug immediately and immediately inform your study doctor. Your study 
doctor will report all cases of pregnancy to Celgene Corporation
• 
Do not breastfeed while taking study drug
• 
The study doctor will be able to advise you where to get additional advice on 
contraception.
Sponsor: MorphoSys AG
Confidential
Page 129 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
If you are a female not of childbearing potential:
In order to ensure that an unborn baby is not exposed to lenalidomide, your study 
doctor will confirm that you are not able to become pregnant.
If you are a male:
Lenalidomide is detected in trace quantities in human semen. The risk to the foetus in 
females of child bearing potential whose male partner is receiving lenalidomide is 
unknown at this time.
• 
Male subjects (including those who have had a vasectomy) must practice complete 
abstinence or must use a condom during sexual contact with a pregnant female or a 
female that can become pregnant:
-  While you are taking study drug
-  During dose interruptions of study drug
-  For 28 days after you stop taking study drug
• 
Male subjects should not donate sperm or semen while taking study drug and for 
28 days after stopping study drug.
• 
If you suspect that your partner is pregnant any time during the study, you 
must immediately inform your study doctor. The study doctor will report all 
cases of pregnancy to Celgene Corporation. Your partner should call their 
healthcare provider immediately if they get pregnant.
2. Restrictions in sharing study drug and donating blood:
• 
Do not share study drug with other people. It must be kept out of the reach of 
children and should never be given to any other person.
• 
Do not donate blood while you take study drug and for 28 days after stopping 
study drug.
• 
Do not break, chew, or open study drug capsules.
• 
You will get no more than a 28-day supply of study drug at one time.
• 
Return unused study drug capsules to your study doctor.
Additional information is provided in the informed consent form and you can ask your 
study doctor for more information.
Sponsor: MorphoSys AG
Confidential
Page 130 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.8.2 Pomalidomide (CC-4047) Pregnancy Prevention Risk Minimization Plan
18.8.2.1 Pomalidomide Pregnancy Risk Minimization Plan for Clinical Trials
Appendix 18.8.2.1 applies to all subjects receiving POM therapy. The following Pregnancy
risk minimization plan documents are included in this Appendix:
1) Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable 
Birth Control Methods (Appendix 18.8.2.2);
2) Pomalidomide Education and Counselling Guidance Document (Appendix 18.8.2.3);
3) Pomalidomide Information Sheet (Appendix 18.8.2.4).
1. The Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable 
Birth Control Methods document (Appendix 18.8.2.2) provides the following information:
• 
Potential risks to the fetus associated with POM exposure
• 
Definition of Female of Childbearing Potential (FCBP)
• 
Pregnancy testing requirements for subjects receiving POM who are females of 
childbearing potential
• 
Acceptable birth control methods for both female of childbearing potential and male 
subjects receiving POM in the study
• 
Requirements for counselling of all study subjects receiving POM about pregnancy 
precautions and the potential risks of fetal exposure to POM
2. The Pomalidomide Education and Counselling Guidance Document (Appendix 18.8.2.3) 
must be completed and signed by either a trained counselor or the Investigator at the 
participating clinical center prior to each dispensing of POM study treatment. A copy of 
this document must be maintained in the subject records.
3. The Pomalidomide Information Sheet (Appendix 18.8.2.4) will be given to each subject 
receiving POM study therapy. The subject must read this document prior to starting POM 
study treatment and each time they receive a new supply of study drug.
Sponsor: MorphoSys AG
Confidential
Page 131 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.8.2.2 Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and 
Acceptable Birth Control Methods
Risks Associated with Pregnancy
POM was found to be teratogenic in a developmental study in rabbits. POM is an analogue of 
thalidomide. Thalidomide is a known human teratogen that causes severe life-threatening 
human birth defects. If POM is taken during pregnancy, it may cause birth defects or death to 
an unborn baby.
Criteria for females of childbearing potential (FCBP)
This protocol defines a female of childbearing potential as a sexually mature woman who:
1) has not undergone a hysterectomy or bilateral oophorectomy or
2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule 
out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time 
in the preceding 24 consecutive months).
Counselling
For a female of childbearing potential, POM is contraindicated unless all of the following are 
met (i.e., all females of childbearing potential must be counselled concerning the following 
risks and requirements prior to the start of POM study therapy):
• 
She understands the potential teratogenic risk to the unborn child
• 
She understands the need for effective contraception, without interruption, 28 days 
before starting study treatment, throughout the entire duration of study treatment, 
dose interruption and 28 days after the end of study treatment
• 
She should be capable of complying with effective contraceptive measures
• 
She is informed and understands the potential consequences of pregnancy and the 
need to notify her study doctor immediately if there is a risk of pregnancy
• 
She understands the need to commence the study treatment as soon as study drug is 
dispensed following a negative pregnancy test
• 
She understands the need and accepts to undergo pregnancy testing based on the 
frequency outlined in this protocol (Appendix 18.8.2.2)
• 
She acknowledges that she understands the hazards and necessary precautions 
associated with the use of POM
The investigator must ensure that females of childbearing potential:
• 
Comply with the conditions for pregnancy risk management, including confirmation 
that she has an adequate level of understanding
• 
Acknowledge the aforementioned requirements
Sponsor: MorphoSys AG
Confidential
Page 132 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
For a female NOT of childbearing potential, POM is contraindicated unless all of the following 
are met (i.e., all females NOT of childbearing potential must be counselled concerning the 
following risks and requirements prior to the start of POM study therapy):
• 
She acknowledges that she understands the hazards and necessary precautions 
associated with the use of POM
The effect of POM on spermatogenesis is not known and has not been studied. Therefore, male 
subjects taking POM must meet the following conditions (i.e., all males must be counselled 
concerning the following risks and requirements prior to the start of POM study therapy):
• 
Understand the potential teratogenic risk if engaged in sexual activity with a 
pregnant female or a female of childbearing potential
• 
Understand the need for the use of a condom even if he has had a vasectomy, if 
engaged in sexual activity with a pregnant female or a female of childbearing 
potential.
Contraception
Females of childbearing potential (FCBP) enrolled in this protocol must agree to use two 
reliable forms of contraception simultaneously or to practice complete abstinence from 
heterosexual contact during the following time periods related to this study:
1) for at least 28 days before starting study drug;
2) while participating in the study;
3) dose interruptions; and
4) for at least 28 days after study treatment discontinuation.
The two methods of reliable contraception must include one highly effective method and one 
additional effective (barrier) method. FCBP must be referred to a qualified provider of 
contraceptive methods if needed. The following are examples of highly effective and additional 
effective methods of contraception:
• 
Highly effective methods:
-  
Intrauterine device (IUD)
-  Hormonal (birth control pills, injections, implants)
-  
Tubal ligation
-  Partner’s vasectomy
• 
Additional effective methods:
-  Male condom
-  Diaphragm
-  
Cervical Cap
Because of the increased risk of venous thromboembolism in patients with multiple myeloma 
taking POM and DEX, combined oral contraceptive pills are not recommended. If a subject is
Sponsor: MorphoSys AG
Confidential
Page 133 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
currently using combined oral contraception, the subject should switch to another one of the 
effective methods listed above. The risk of venous thromboembolism continues for 4-6 weeks 
after discontinuing combined oral contraception. The efficacy of contraceptive steroids may be 
reduced during co-treatment with DEX.
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk 
of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics 
should be considered particularly in subjects with neutropenia.
Pregnancy testing
Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be 
performed for females of childbearing potential, including females of childbearing potential 
who commit to complete abstinence, as outlined below.
Before starting study drug
Female Subjects:
FCBP must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to 
starting study drug. The first pregnancy test must be performed within 10-14 days prior to the 
start of study drug and the second pregnancy test must be performed within 24 hours prior to 
the start of study drug. The subject may not receive study drug until the study doctor has 
verified that the results of these pregnancy tests are negative.
Male Subjects:
Must practice complete abstinence or agree to use a condom during sexual contact with a 
pregnant female or a female of childbearing potential while participating in the study, during 
dose interruptions and for at least 28 days following study drug discontinuation, even if he has 
undergone a successful vasectomy.
During study participation and for 28 days following study drug discontinuation
Female Subjects:
• 
FCBP with regular or no menstrual cycles must agree to have pregnancy tests 
weekly for the first 28 days of study participation and then every 28 days while on 
study, at study discontinuation, and at day 28 following study drug discontinuation. 
If menstrual cycles are irregular, the pregnancy testing must occur weekly for the 
first 28 days and then every 14 days while on study, at study discontinuation, and at 
days 14 and 28 following study drug discontinuation.
• 
At each visit, the Investigator must confirm with the FCBP that she is continuing to 
use two reliable methods of birth control.
• 
Counselling about pregnancy precautions and the potential risks of fetal exposure 
must be conducted at a minimum of every 28 days.
• 
If pregnancy or a positive pregnancy test does occur in a study subject, study drug 
must be immediately discontinued.
Sponsor: MorphoSys AG
Confidential
Page 134 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Pregnancy testing and counselling must be performed if a subject misses her period 
or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment 
must be discontinued during this evaluation.
• 
Females must agree to abstain from breastfeeding during study participation and for 
at least 28 days after study drug discontinuation.
Male Subjects:
• 
Counselling about the requirement for complete abstinence or condom use during 
sexual contact with a pregnant female or a female of childbearing potential and the 
potential risks of fetal exposure to POM must be conducted at a minimum of every 
28 days.
• 
If pregnancy or a positive pregnancy test does occur in the partner of a male study 
subject during study participation, the investigator must be notified immediately.
Additional precautions
• 
Subjects should be instructed never to give this medicinal product to another person 
and to return any unused capsules to the study doctor at the end of treatment.
• 
Subjects should not donate blood during therapy and for at least 28 days following 
discontinuation of study drug.
• 
Male subjects should not donate semen or sperm during therapy or for at least 
28 days following discontinuation of study drug.
• 
Only enough study drug for one cycle of therapy may be dispensed with each cycle 
of therapy.
Sponsor: MorphoSys AG
Confidential
Page 135 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.8.2.3 Pomalidomide Education and Counselling Guidance Document 
To be completed prior to each dispensing of study drug.
Protocol Number:
Subject Name (Print):___________________ D O B:_____ /_____ /_____ (mm/dd/yyyy)
(Check the appropriate box to indicate risk category)
Female:
If female, check one:
FCBP (Female of childbearing potential): sexually mature female who: 1) has 
not undergone a hysterectomy (the surgical removal of the uterus) or bilateral 
oophorectomy (the surgical removal of both ovaries) or 2) has not been 
naturally postmenopausal (amenorrhea following cancer therapy does not rule 
out childbearing potential) for at least 24 consecutive months (i.e., has had 
menses at any time during the preceding 24 consecutive months)
NOT FCBP
Male:
Do Not Dispense study drug if:
• 
The subject is pregnant.
• 
No pregnancy tests were conducted for a FCBP.
• 
The subject states she did not use TWO reliable methods of birth control 
(unless practicing complete abstinence of heterosexual contact) [at least 
28 days prior to therapy, during therapy and during dose interruption].
FCBP:
1. 
I verified that the required pregnancy tests performed are negative.
2. 
I counselled FCBP regarding the following:
• 
Potential risk of fetal exposure to pomalidomide: If pomalidomide is taken during 
pregnancy, it may cause birth defects or death to any unborn baby. Females are 
advised to avoid pregnancy while taking pomalidomide. The teratogenic potential 
of pomalidomide in humans cannot be ruled out. FCBP must agree not to become 
pregnant while taking pomalidomide.
• 
Using TWO reliable methods of birth control at the same time or complete 
abstinence from heterosexual contact [at least 28 days prior to therapy, during 
therapy, during dose interruption and 28 days after discontinuation of study drug]. •
• 
That even if she has amenorrhea she must comply with advice on contraception
Sponsor: MorphoSys AG
Confidential
Page 136 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
• 
Use of one highly effective method and one additional method of birth control AT 
THE SAME TIME. The following are examples of highly effective and additional 
effective methods of contraception:
-  Highly effective methods:
o 
Intrauterine device (IUD)
o 
Hormonal (birth control pills, injections, implants) 
o 
Tubal ligation 
o 
Partner’s vasectomy
-  
Additional effective methods: 
o Male condom
o 
Diaphragm 
o 
Cervical Cap
• 
Pregnancy tests before and during treatment, even if the subject agrees not to have 
reproductive heterosexual contact. Two pregnancy tests will be performed prior to 
receiving study drug, one within 10-14 days and the second within 24 hours of the 
start of study drug.
• 
Frequency of pregnancy tests to be done:
-  Every week during the first 28 days of this study and a pregnancy test every 
28 days during the subject’s participation in this study if menstrual cycles are 
regular or every 14 days if cycles are irregular.
-  
If the subject missed a period or has unusual menstrual bleeding.
-  When the subject is discontinued from the study and at day 28 after study drug 
discontinuation if menstrual cycles are regular. If menstrual cycles are irregular, 
pregnancy tests will be done at discontinuation from the study and at days 14 
and 28 after study drug discontinuation.
• 
Stop taking study drug immediately in the event of becoming pregnant and to call 
their study doctor as soon as possible.
• 
NEVER share study drug with anyone else.
• 
Do not donate blood while taking study drug and for 28 days after stopping study 
drug.
• 
Do not breastfeed a baby while participating in this study and for at least 28 days 
after study drug discontinuation.
• 
Do not break, chew, or open study drug capsules.
• 
Return unused study drug to the study doctor.
3. 
Provide Pomalidomide Information Sheet to the subject.
Sponsor: MorphoSys AG
Confidential
Page 137 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
FEMALE NOT OF CHILDBEARING POTENTIAL (NATURAL MENOPAUSE FOR
AT LEAST 24 CONSECUTIVE MONTHS, A HYSTERECTOMY, OR BILATERAL
OOPHORECTOMY):
1. 
I counselled the female NOT of childbearing potential regarding the following:
• 
Potential risk of fetal exposure to pomalidomide (Refer to item #2 in FCBP)
• 
NEVER share study drug with anyone else.
• 
Do not donate blood while taking study drug and for 28 days after stopping study 
drug.
• 
Do not break, chew, or open study drug capsules
• 
Return unused study drug capsules to the study doctor.
2. 
Provide Pomalidomide Information Sheet to the subject.
MALE:
1. 
I counselled the Male subject regarding the following:
• 
Potential study drug fetal exposure to pomalidomide (Refer to item #2 in FCBP).
• 
To engage in complete abstinence or use a condom when engaging in sexual contact 
(including those who have had a vasectomy) with a pregnant female or a female of 
childbearing potential, while taking study drug, during dose interruptions and for 
28 days after stopping study drug.
• 
Males should notify their study doctor when their female partner becomes pregnant 
and female partners of males taking study drug should be advised to call their 
healthcare provider immediately if they get pregnant
• 
NEVER share study drug with anyone else.
• 
Do not donate blood while taking study drug and for 28 days after stopping study 
drug.
• 
Do not donate semen or sperm while taking study drug and for 28 days after 
stopping study drug.
• 
Do not break, chew, or open study drug capsules.
• 
Return unused study drug capsules to the study doctor.
2. 
Provide Pomalidomide Information Sheet to the subject.
Investigator/Counselor Name (Print):_____________________
(circle applicable)
Investigator/Counselor Signature:_________________________ 
D ate:_____ /_____ /_____
(circle applicable)
**Maintain a copy of the Education and Counselling Guidance Document in the subject records.**
Sponsor: MorphoSys AG
Confidential
Page 138 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.8.2.4 Pomalidomide Information Sheet
FOR SUBJECTS ENROLLED IN CLINICAL RESEARCH STUDIES
Please read this Pomalidomide Information Sheet before you start taking study drug 
and each time you get a new supply. This Pomalidomide Information Sheet does not 
take the place of an informed consent to participate in clinical research or talking to 
your study doctor or healthcare provider about your medical condition or your 
treatment.
W hat is the m ost im portant inform ation I  sh o u ld  kn ow  abou t pom alidom ide?
1. Pomalidomide may cause birth defects (deformed babies) or death of an 
unborn baby. Pomalidomide is similar to the medicine thalidomide. It is 
known that thalidomide causes life-threatening birth defects. Pomalidomide has 
not been tested in pregnant women but may also cause birth defects.
Pomalidomide was found to cause birth defects when tested in pregnant rabbits.
If you are a female who is able to become pregnant:
• 
Do not take study drug if you are pregnant or plan to become pregnant
• 
You must either not have any sexual relations with a man or use two reliable, 
separate forms of effective birth control at the same time:
-  
for 28 days before starting study drug
-  while taking study drug
-  
during dose interruptions of study drug
-  
for 28 days after stopping study drug
• 
You must have pregnancy testing done at the following times:
-  within 10 -  14 days and again 24 hours prior to the first dose of study drug
-  weekly for the first 28 days
-  
every 28 days after the first month or every 14 days if you have irregular 
menstrual periods
-  
if you miss your period or have unusual menstrual bleeding
-  
28 days after the last dose of study drug (14 and 28 days after the last dose if 
menstrual periods are irregular)
• 
Stop taking study drug if you become pregnant during treatment
-  
If you suspect you are pregnant at any time during the study, you must stop 
study drug immediately and immediately inform your study doctor. The study 
doctor will report all cases of pregnancy to Celgene Corporation.
• 
Do not breastfeed while taking study drug
• 
The study doctor will be able to advise you where to get additional advice on 
contraception.
Sponsor: MorphoSys AG
Confidential
Page 139 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
If you are a female not of childbearing potential:
In order to ensure that an unborn baby is not exposed to pomalidomide, your study 
doctor will confirm that you are not able to become pregnant.
If you are a male:
The effect of pomalidomide on sperm development is not known and has not been 
studied. The risk to the fetus in females of child bearing potential whose male partner is 
receiving pomalidomide is unknown at this time.
1. Male subjects (including those who have had a vasectomy) must either 
not have any sexual relations with a pregnant female or a female 
who can become pregnant, or must use a condom during sexual 
contact with a pregnant female or a female that can become pregnant:
o 
While you are taking study drug
o 
During dose interruptions of study drug
o 
For 28 days after you stop taking study drug
2. Male subjects should not donate sperm or semen while taking study 
drug and for 28 days after stopping study drug.
3. If you suspect that your partner is pregnant any time during the 
study, you must immediately inform your study doctor. The study 
doctor will report all cases of pregnancy to Celgene Corporation.
Your partner should call their healthcare provider immediately if 
they get pregnant.
2. Restrictions in sharing study drug and donating blood:
1. Do not share study drug with other people. It must be kept out of 
the reach of children and should never be given to any other person.
2. Do not donate blood while you take study drug and for 28 days after 
stopping study drug.
3. Do not break, chew, or open study drug capsules.
4. You will be supplied with no more than one cycle of study drug
5. Return unused study drug capsules to your study doctor.
Additional information is provided in the informed consent form and you can 
ask your study doctor for more information.
Sponsor: MorphoSys AG
Confidential
Page 140 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
18.9 Venous Thrombotic Event Algorithms
Venous Thrombotic Event (VTE) Diagnostic Procedure
1. 
Refer to the DVT Pre-Test Probability Score Table (Table 20). Add up the score and 
determine the subject’s pre-test probability for DVT.
2. 
Refer to the DVT Diagnostic Algorithm (Figure 4). According to the pre-test probability 
follow the relevant diagnostic algorithm.
Table 20 
Wells1 Deep Vein Thrombosis Pre-Test Probability (PTP) Score
Clinical Characteristic
Score
Active cancer (treatment ongoing or within previous 6 months or palliative)
1
Paralysis, paresis, or recent plaster immobilization of the lower extremities
1
Recently bedridden for 3 days or more or major surgery within the previous 
12 weeks requiring general or regional anesthesia
1
Localized tenderness along the distribution of the deep venous system
1
Entire leg swollen
1
Calf swelling 3cm > asymptomatic side (measured 10 cm below tibial tuberosity)
1
Pitting oedema confined to the symptomatic leg
1
Collateral superficial veins (nonvaricose)
1
Previously documented deep-vein thrombosis
1
Alternative diagnosis as likely or greater than that of DVT
-2
1 Wells PS, Anderson D et al. Evaluation of D-dimer in the Diagnosis of Suspected Deep Vein Thrombosis. N Engl 
J Med Sept 25, 2003 349(13): 1227-35
Sponsor: MorphoSys AG
Confidential
Page 141 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
Adapted from 6B6 D-Dimertm The Essential Element Wall Chart
Figure 4: 
Deep Vein Thrombosis Diagnostic Algorithm
Pulmonary Embolism (PE) Diagnostic Procedure
1. 
Refer to the PE Pre-Test Probability Score Table (Table 21). Add up the score and determine 
the subject’s pre-test probability for PE.
2. 
Refer to the PE Diagnostic Algorithm (Figure 5). According to the pre-test probability 
follow the relevant diagnostic algorithm.
Table 21 
Wells1 Pulmonary Embolism Pre-Test Probability (PTP) Score
Clinical Characteristic
Score
Clinical signs and symptoms of DVT (minimum of leg swelling and pain with 
palpation of the deep veins)
3.0
An alternative diagnosis is less likely than PE
3.0
Heart rate greater than 100 beats/min
1.5
Immobilization or surgery in the previous 4 weeks
1.5
Previous DVT/PE
1.5
Hemoptysis
1.0
Malignancy (at treatment, treated in the last 6 months or palliative)
1.0
1 Wells P.S., Anderson D. et al. Derivation of a simple Clinical Model to Categorize Patients Probability of 
Pulmonary Embolism: Increasing the Models Utility with SimpliRED D-dimer. Thromb Haemost 2000;83:416-20
Sponsor: MorphoSys AG
Confidential
Page 142 of 143


Product Name: MOR03087
Date: 17 Jul 2017
Protocol Amendment 11, Final 12.0
Protocol Number: MOR202C101
EudraCT Number: 2009-015942-50
PTP Score
Low Probability
<2.0
M oderate Probability
2.0 -  6.0
High Probability
>6.0
Figure 5: 
Pulmonary Embolism Diagnostic Algorithm
Sponsor: MorphoSys AG
Confidential
Page 143 of 143

SAP_001.pdf: 
 
 
 
Statistical Analysis Plan 
Protocol Title: 
A Phase I/IIa, Open-Label, Multicentre, Dose-Escalation Study to 
Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD38 
Antibody MOR03087 as Monotherapy and in Combination with 
Standard Therapy in Subjects with Relapsed or Refractory Multiple 
Myeloma 
Protocol 
Number: 
MOR202C101 (Version 12.0, dated 17-JUL-2017) 
Compound: 
MOR03087 
Phase: 
I/IIa 
Sponsor: 
MorphoSys AG 
 
 
 
SAP Author: 
 
 
 
 
 
 
SAP Version: 
FINAL Version 3.0 
SAP Date: 
28-SEP-2020 
CONFIDENTIAL 


Protocol: MOR202C101 
 
Page 2 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
DOCUMENT HISTORY 
Version 
Date 
Author 
Description 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  


Protocol: MOR202C101 
 
Page 3 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 






Protocol: MOR202C101 
 
Page 5 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
TABLE OF CONTENTS 
DOCUMENT HISTORY .................................................................................................. 2 
SIGNATURE PAGE AND APPROVALS ...................................................................... 4 
TABLE OF CONTENTS .................................................................................................. 5 
ABBREVIATIONS ............................................................................................................ 8 
1. 
OVERVIEW ......................................................................................................... 10 
2. 
STUDY OBJECTIVES AND ENDPOINTS ..................................................... 11 
2.1 
Study Objectives ........................................................................................ 11 
2.1.1 Primary Objective .......................................................................... 11 
2.1.2 Secondary Objectives .................................................................... 11 
2.2 
Safety, Efficacy, and Pharmacokinetic/Pharmacodynamic Endpoints ...... 11 
2.2.1 Primary Endpoints ......................................................................... 11 
2.2.2 Secondary Endpoints ..................................................................... 12 
3. 
STUDY METHODS ............................................................................................ 12 
3.1 
Overall Study Design and Plan .................................................................. 12 
3.2 
Selection of Study Population ................................................................... 16 
3.3 
Method of Treatment Assignment and Randomization ............................. 17 
3.4 
Treatment Masking (Blinding) .................................................................. 17 
4. 
ANALYSIS AND REPORTING ........................................................................ 17 
4.1 
DMC Analysis ........................................................................................... 17 
4.2 
Final Analysis ............................................................................................ 18 
4.3 
Follow-up Analyses ................................................................................... 18 
5. 
SAMPLE SIZE DETERMINATION ................................................................ 18 
6. 
ANALYSIS POPULATIONS ............................................................................. 18 
7. 
GENERAL ISSUES FOR STATISTICAL ANALYSIS .................................. 19 
7.1 
General Statistical Methodology ............................................................... 19 
7.2 
Structure of Tables ..................................................................................... 20 
7.3 
Derived and Computed Variables .............................................................. 21 
7.3.1 Baseline Variables ......................................................................... 21 
7.3.2 Immunogenicity ............................................................................. 22 
7.3.3 Efficacy Endpoints Based on Investigator Assessment ................. 23 
7.3.4 Quantitative Efficacy Variables based on Serum or Urine M-Protein, 
and/or Serum FLCs ........................................................................ 28 


Protocol: MOR202C101 
 
Page 6 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
7.3.5 Quality of Life ............................................................................... 29 
7.3.6 Exposure ........................................................................................ 30 
7.4 
Subgroups Used for Efficacy Analysis ...................................................... 36 
8. 
STUDY SUBJECTS AND DEMOGRAPHICS ................................................ 38 
8.1 
Disposition of Subjects and Withdrawals .................................................. 38 
8.2 
Protocol Non-compliances ......................................................................... 38 
8.3 
Demographics and Other Baseline Characteristics .................................... 39 
9. 
IMMUNOGENICITY, 
EFFICACY 
AND 
PHARMACODYNAMIC 
ANALYSES .......................................................................................................... 41 
9.1 
Immunogenicity Analysis .......................................................................... 41 
9.2 
Efficacy Analysis ....................................................................................... 42 
9.2.1 Subgroup Analysis ......................................................................... 43 
9.3 
Pharmacodynamic Analysis....................................................................... 43 
9.3.1 Pharmacodynamic Parameters Measured in Blood or Urine ......... 43 
9.3.2 Pharmacodynamic Parameters Measured in Bone Marrow ........... 44 
9.4 
Pharmacokinetic Analysis ......................................................................... 45 
9.5 
Other Parameters ....................................................................................... 45 
9.5.1 Cytokines ....................................................................................... 45 
9.5.2 Bone / Skeletal Survey ................................................................... 46 
9.5.3 Quality of Life ............................................................................... 46 
10. 
SAFETY AND TOLERABILITY ANALYSES ................................................ 46 
10.1 
Dose Limiting Toxicities and Maximum Tolerated Dose ......................... 46 
10.2 
Adverse Events .......................................................................................... 48 
10.3 
Clinical Laboratory Evaluations ................................................................ 52 
10.4 
Vital Signs and Body Weight .................................................................... 54 
10.5 
Electrocardiograms .................................................................................... 54 
10.6 
Physical Examination ................................................................................ 55 
10.7 
Measurement of Exposure ......................................................................... 55 
10.8 
Karnofsky Performance Status .................................................................. 55 
11. 
REPORTING CONVENTIONS ........................................................................ 56 
11.1 
General Reporting Conventions ................................................................ 56 
11.2 
Population Summary Conventions ............................................................ 57 
12. 
REFERENCES .................................................................................................... 58 


Protocol: MOR202C101 
 
Page 7 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
13. 
TABLES, LISTINGS, AND FIGURES ............................................................. 59 
13.1 
Planned Table Descriptions ....................................................................... 59 
13.2 
Planned Listing Descriptions ..................................................................... 74 
13.3 
Planned Figure Descriptions ...................................................................... 77 
 


Protocol: MOR202C101 
 
Page 8 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
ABBREVIATIONS 
ABBREVIATION 
DEFINITION OR DESCRIPTION 
AE 
Adverse Event 
ATC 
Anatomical Therapeutic Chemical 
BMI 
Body Mass Index 
CBR 
Clinical Benefit Rate 
CD38 
Cluster of Differentiation 38 (antigen expressed on malignant 
plasma cells) 
CR 
Complete Response 
CRF 
Case Report Form 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
Coefficient of Variation 
DCR  
Disease Control Rate 
DEX 
Dexamethasone 
DLT 
Dose Limiting Toxicity 
DMC 
Data Monitoring Committee 
DoCB 
Duration of Clinical Benefit 
DoR 
Duration of Response 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EBMT 
European Group for Blood and Marrow Transplantation 
EFS 
Event-free Survival 
EMA 
European Medicines Agency 
EORTC 
European Organisation for Research and Treatment of Cancer 
EOS 
End of Study 
FDA 
Food and Drug Administration 
FLC 
Free Light Chain 
ICH 
International Conference on Harmonisation 
IMiD 
Immunomodulatory Drug 
IMP 
Investigational Medical Product 
ISS 
International Staging System Criteria 
LEN 
Lenalidomide 
MedDRA 
Medical Dictionary for Regulatory Activities 
MFI 
Median Fluorescence Intensity 


Protocol: MOR202C101 
 
Page 9 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
MM 
Multiple Myeloma 
MR 
Minimal Response 
MTD 
Maximum Tolerated Dose 
NCI-CTC 
Common Terminology Criteria of the National Cancer Institute 
NCI-CTCAE 
Common Terminology Criteria of the National Cancer Institute 
for Adverse Events 
NE 
Not Evaluable 
NK 
Natural Killer 
ORR 
Overall Response Rate 
PD 
Progressive Disease 
PFS 
Progression-free Survival 
PI 
Proteasome Inhibitor 
POM 
Pomalidomide 
PR 
Partial Response 
QLQ-C30 
Quality of Life Questionnaire for Cancer Subjects – 
30 questions 
QLQ-MY20 
Quality of Life Questionnaire for Myeloma Subjects – 
20 questions 
QoL 
Quality of Life  
QTc 
QT-interval for ECG corrected for heart rate 
RS 
Raw Score 
SAE 
Serious Adverse Event 
SAP  
Statistical Analysis Plan 
sCR 
Stringent Complete Response 
SD  
Stable Disease 
SI 
Standard International 
SOC 
System Organ Class 
TEAE 
Treatment-emergent Adverse Event 
TTP 
Time to Progression 
TTNT 
Time to Next Treatment 
VGPR 
Very Good Partial Response 
WHO 
World Health Organization 
 


Protocol: MOR202C101 
 
Page 10 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
1. OVERVIEW 
This Statistical Analysis Plan (SAP) describes the planned analysis and reporting for MorphoSys 
protocol MOR202C101, Version 12.0, dated 17-JUL-2017. 
This phase I/IIa, open-label, multicentre, dose-escalation study is being conducted to characterize 
the safety profile, assess preliminary efficacy and establish the maximal tolerated dose (MTD) 
or recommended dose of MOR03087 as monotherapy and in combination with dexamethasone 
(DEX) as well as in combination with immunomodulatory drugs (IMiDs) such as Pomalidomide 
(POM) and Lenalidomide (LEN) (MOR03087 + POM/DEX and MOR 03087 + LEN/DEX) in 
adult subjects with relapsed or refractory multiple myeloma (MM). 
The structure and content of this SAP provides sufficient detail to meet the requirements 
identified by the Food and Drug Administration (FDA), European Medicines Agency (EMA), 
and International Conference on Harmonisation (ICH) of Technical Requirements for 
Registration of Pharmaceuticals for Human Use: Guidance on Statistical Principles in Clinical 
Trials [1]. All work planned and reported for this SAP will follow internationally accepted 
guidelines, published by the American Statistical Association [2] and the Royal Statistical 
Society [3], for statistical practice. 
The planned analysis identified in this SAP may be included in clinical study reports (CSRs), 
regulatory submissions, or future manuscripts. Also, post-hoc exploratory analysis not 
necessarily identified in this SAP may be performed to further examine study data and will not 
require updating the final SAP. Any post-hoc, or unplanned, exploratory analysis performed will 
be clearly identified as such and described in the final CSR. 
The following documents were reviewed in preparation of this SAP: 
• Clinical Research Protocol MOR202C101, Version 12.0, dated 17-JUL-2017 
• Case report forms (CRFs) for Protocol MOR202C101 
• ICH Guidance on Statistical Principles for Clinical Trials (E9). 
The reader of this SAP is encouraged to also read the clinical protocol, and other identified 
documents, for details on the conduct of this study. Operational aspects related to collection and 
timing of clinical assessments are not repeated in this SAP unless relevant to the planned analysis. 


Protocol: MOR202C101 
 
Page 11 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
2. STUDY OBJECTIVES AND ENDPOINTS 
2.1 Study Objectives 
2.1.1 Primary Objective 
The primary objectives are 
1. To assess the safety profile and to establish the maximum tolerated dose (MTD) and/or 
recommended dose of MOR03087 in subjects with relapsed or refractory MM:  
a. As monotherapy 
b. In combination with DEX 
c. In combination with POM + DEX 
d. In combination with LEN + DEX 
2. To assess the immunogenicity of MOR03087 
2.1.2 Secondary Objectives 
Secondary objectives are  
1. To evaluate the pharmacokinetics and pharmacodynamics of MOR03087 in subjects with 
relapsed or refractory MM: 
a. As monotherapy 
b. In combination with DEX 
c. In combination with POM + DEX 
d. In combination with LEN + DEX 
 
2. To evaluate the preliminary efficacy of MOR03087 in subjects with relapsed or refractory 
MM: 
a. As monotherapy 
b. In combination with DEX 
c. In combination with POM + DEX 
d. In combination with LEN + DEX 
 
2.2 
Safety, Efficacy, and Pharmacokinetic/Pharmacodynamic Endpoints  
2.2.1 Primary Endpoints 
The primary endpoints are 
1. Determination of the MTD and/or recommended dose of MOR03087 as monotherapy, in 
combination with DEX, and in combination with POM + DEX and LEN + DEX 
2. Determination of the recommended dosing regimen of MOR03087 
3. Incidence and severity of adverse events (AEs) 
4. Immunogenicity of MOR03087 based on both absolute (number and percentage of subjects 
who develop anti-MOR03087 antibodies) and semi-quantitative (anti-MOR03087 antibody 
titer determination of confirmed positive samples) assessments 


Protocol: MOR202C101 
 
Page 12 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
2.2.2 Secondary Endpoints 
Secondary endpoints are 
1. Pharmacokinetics of MOR03087 +/- LEN or POM 
2. Absolute and percent change from baseline in measurements of B, T, and natural killer (NK) 
cell populations 
3. Overall response rate (stringent complete response [sCR], complete response [CR], very 
good partial response [VGPR], partial response [PR]), further tumor response rates (CR, sCR, 
PR, minimal response [MR], VGPR), and stable disease (SD) rate 
4. Duration of response (DoR), time to progression (TTP), and progression-free survival (PFS) 
5. Absolute and percent change from baseline in serum and urine M-protein levels 
6. Absolute and percent change from baseline in serum free light chain (FLC) levels and serum 
FLC ratio 
7. Absolute changes from baseline in laboratory parameters (serum chemistry, haematology, 
urinalysis) and clinically relevant abnormal values 
8. Absolute change from baseline in overall quality of life scores  
9. Change in cytokines from baseline 
 
3. STUDY METHODS 
3.1 Overall Study Design and Plan  
This is an open-label, multicentre, standard 3+3 dose-escalation study designed to characterize 
the safety profile and to assess the preliminary efficacy of MOR03087 in adult subjects with 
relapsed or refractory MM as monotherapy and in combination with DEX or standard IMiD 
therapy (POM and LEN). Approximately 10-15 sites will participate in this study. 
The MTD and/or recommended dose and dosing regimens will be confirmed in a confirmation 
cohort of at least 6 subjects. A total of up to 126 subjects may participate in the study (including 
dose escalation and confirmation cohorts).  
In each cohort, 28-day cycles will be used. 
An independent Data Monitoring Committee (DMC) will review the relevant safety information 
before considering dose escalation for the next cohort. 
Part A: MOR03087 dose escalation (bi-weekly treatment - q2w): 
Up to 8 dose levels of MOR03087 will be evaluated: 
• Cohort 1 - Dose level 1: 0.01 mg/kg 
• Cohort 2 - Dose level 2: 0.04 mg/kg 
• Cohort 3 - Dose level 3: 0.15 mg/kg 
• Cohort 4 - Dose level 4: 0.5 mg/kg 
• Cohort 5 - Dose level 5: 1.5 mg/kg 
• Cohort 6 - Dose level 6: 4.0 mg/kg 
• Cohort 7 - Dose level 7: 8.0 mg/kg 
• Cohort 8 - Dose level 8: 16.0 mg/kg 


Protocol: MOR202C101 
 
Page 13 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Each 28-day cycle will consist of: 
MOR03087 infusion on Day 1 and Day 15 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle. 
At least 48 hours will pass between the first study drug administration to the subjects within a 
cohort in order to observe for AEs. 
  
Part B: MOR03087 dose escalation (weekly treatment - q1w): 
• Dose level 6b: 4.0 mg/kg  
• Dose level 7b: 8.0 mg/kg 
• Dose level 8b: 16.0 mg/kg 
Each 28-day cycle will consist of: 
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle. 
 
Part C: MOR03087 dose escalation (weekly/biweekly treatment - q1w/q2w) plus low dose of 
DEX: 
• Dose level 6c: 4.0 mg/kg 
• Dose level 7c: 8.0 mg/kg 
• Dose level 8c: 16.0 mg/kg  
Each 28-day cycle will consist of: 
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle. 
Only for dose level 8c, for cycle 4 and onwards each 28-cycle will consist of:  
MOR03087 infusion on Day 1 and 15 of the cycle. 
Subjects who have received treatment beyond Cycle 3 will be switched to the biweekly schedule 
at the next Day 1 or Day 15 visit. In exceptional cases, and after discussion between the 
investigator and the sponsor, the treating physician may determine that it is in the best interest of 
the subject to remain on the weekly MOR03087 schedule, in which case the sponsor should be 
informed accordingly. 
The low dose of DEX is defined as a single dose of 40 mg or lower (as described in protocol 
section 7.1), once, to be orally administered on days of MOR03087 infusion. 
For subjects in Cohort 8c who switch to biweekly MOR03087 treatment from Cycle 4 onwards, 
the DEX treatment schedule will remain unchanged (Day 1, 8, 15 and 22). 
Following the completion of Part B dose level 6b and Part C dose level 6c, and taking into account 
available safety information from Part A dose level 8, the DMC will provide recommendation if 
some or all of the planned weekly MOR03087 monotherapy dose escalation cohorts will be 
tested.   
Following completion of Parts A, B, and C (dose escalation of MOR03087 bi-weekly and weekly 


Protocol: MOR202C101 
 
Page 14 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
regimen), the MTD or recommended dose and schedule will be confirmed in a minimum of 
6 subjects.  
 
Part D: MOR03087 (weekly/biweekly treatment) in combination with POM+DEX 
• Dose level 7d: 8.0 mg/kg 
• Dose level 8d: 16.0 mg/kg 
Each 28-day cycle will consist of: 
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle. 
Only for dose level 8d, for cycle 4 and onwards each 28-day cycle will consist of:  
MOR03087 infusion on Day 1 and 15 of the cycle. 
Subjects who have received treatment beyond Cycle 3 will be switched to the biweekly schedule 
at the next Day 1 or Day 15 visit. In exceptional cases, and after discussion between the 
investigator and the sponsor, the treating physician may determine that it is in the best interest of 
the subject to remain on the weekly MOR03087 schedule, in which case the sponsor should be 
informed accordingly. 
Oral POM 4 mg on Days 1-21 of the 28-day cycle. 
Oral DEX 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of the 
28-day cycle. 
For subjects in Cohort 8d who switch to biweekly MOR03087 treatment from Cycle 4 onwards, 
the DEX treatment schedule will remain unchanged (Day 1, 8, 15 and 22). 
In Cycle 1 DEX is to be added to the loading dose on Day 4. 
 
Part E: MOR03087 (weekly/biweekly treatment) in combination with LEN+DEX 
• Dose level 7e: 8.0 mg/kg  
• Dose level 8e: 16.0 mg/kg 
Each 28-day cycle will consist of:  
MOR03087 infusion on Days 1, 8, 15, and 22 of the cycle. In Cycle 1, a loading dose will 
additionally be administered on Day 4 of the cycle. 
Only for dose level 8e, for cycle 4 and onwards each 28-day cycle will consist of:  
MOR03087 infusion on Day 1 and 15 of the cycle. 
Subjects who have received treatment beyond Cycle 3 will be switched to the biweekly schedule 
at the next Day 1 or Day 15 visit. In exceptional cases, and after discussion between the 
investigator and the sponsor, the treating physician may determine that it is in the best interest of 
the subject to remain on the weekly MOR03087 schedule, in which case the sponsor should be 
informed accordingly. 
Oral LEN 25 mg on Days 1-21 of the 28-day cycle. 
Oral DEX 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of the 


Protocol: MOR202C101 
 
Page 15 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
28-day cycle.  
For subjects in Cohort 8e who switch to biweekly MOR03087 treatment from Cycle 4 onwards, 
the DEX treatment schedule will remain unchanged (Day 1, 8, 15 and 22). 
In Cycle 1 DEX is to be added to the loading dose on Day 4. 
Following completion of Parts D and E (dose escalation of MOR03087 in combination with 
POM + DEX and LEN + DEX), the MTD and/or recommended dose in each part will be 
confirmed in a minimum of 6 subjects.  
 
All cohorts: 
Based on the individual risk/benefit ratio, subjects who have an ongoing response of at least 
stable disease (SD) may continue treatment with the assigned study regimen until disease 
progression or until a maximum of 3 years after first treatment. In case subjects present with 
progressive disease or with no better status than SD after 4 treatment cycles starting with Cycle 1 
Day 1, the investigator may add a low weekly dose of DEX to the regimen at his/her discretion, 
provided DEX is not already part of the treatment regimen. 
After study drug discontinuation due to reason other than disease progression and other than 
withdrawal of consent, all subjects will return for a follow-up visit 1 and follow-up visit 2. Further 
follow-up visits will be conducted at 4-week intervals until the subject is progressive, begins 
subsequent anti-myeloma therapy, or dies. 
All subjects will be followed up for a maximum of 3 years after first administration of study 
drug.  
 
Dose Escalation Process: 
At least 3 subjects meeting all inclusion and none of the exclusion criteria, as determined at the 
screening visit (see sections 8.1 and 8.2 of the study protocol) will be enrolled into each cohort. 
Enrolment into a cohort at the next higher dose level will be based on the data generated from 
the previous dose level and guided by DMC review until 
• the maximum planned dose has been reached, or 
• the review of the safety data indicates a need to either expand the current dose level cohort 
to include 6 subjects or stop the dose escalation or the study, or 
• the review of Part B dose level 6b and Part C dose level 6c, including available safety 
information from Part A dose level 8, indicates that only some of the planned weekly 
MOR03087 monotherapy dose escalation cohorts should be tested.   
The DMC safety review will take place after the third subject enrolled into a cohort has 
undergone minimum safety evaluations (as defined for the “DLT Evaluable Population” in 
section 6). The safety assessment will take into account AEs reported from Day 1 after the start 
of the first infusion through Day 29 (Cycle 2 Day 1) before the start of the second cycle. The 
next cohort will only be started after the positive outcome of the safety assessment. 
Subjects who withdraw whilst their safety assessment period is not evaluable will only be 
replaced during the dose-escalation phase until the applicable cohort consists of a sufficient 
number of evaluable subjects. However, withdrawals due to DLTs will not be replaced. 


Protocol: MOR202C101 
 
Page 16 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Cohort expansion up to 6 subjects will be allowed if a dose limiting toxicity (DLT) (as defined 
in section 8.5 of the study protocol) is observed in 1 of 3 subjects. If 2 or 3 subjects experience a 
DLT in cohorts 6b or 6c, the study sponsor may decide to test a lower dose. If 2 or 3 subjects of 
the 3 subjects in any of the other cohorts experience DLT, then the previous cohort should be 
expanded to 6 subjects.  
Part A dose levels 1-7 will be tested sequentially, and only 1 dose level will be open for enrolment 
at any time. Starting with Part A dose level 8, Parts B and C will open in parallel (at dose level 6 
[6b and 6c]). Following completion of dose level 7c (8.0 mg/kg MOR03087 + DEX) (and dose 
level 7b if the DMC recommends to open this cohort), Cohorts 7d and 7e may open in parallel 
with dose levels 8b (if the DMC recommends to open this cohort) and 8c. New cohorts will not 
start before the DMC returns a positive recommendation based on safety read-outs from prior 
cohorts as laid down in the DMC Charter. 
3.2 Selection of Study Population 
This is a phase I/IIa study in adult subjects with relapsed or refractory MM as monotherapy and 
in combination with standard therapy. Key inclusion criteria identified in the protocol are  
1. Male or female subjects ≥ 18 years of age  
2. Presence of serum M-protein ≥ 0.5 g per 100 mL (≥ 5 g/L) and/or urine M-protein ≥ 200 mg 
per 24-hour period  
3. Life expectancy of > 3 months 
4. Karnofsky performance status ≥ 60% 
5. Absolute neutrophil count ≥ 1.0 (1,000/mm3)   
6. Total bilirubin ≤ 2 × the upper limit of normal (ULN) 
7. Alanine transaminase and aspartate aminotransferase ≤ 2.5 × ULN 
8. Hemoglobin ≥ 8 g/dL 
Additional key inclusion criteria are defined differently for monotherapy and different 
combination therapies: 
Additional Key Inclusion Criteria for Treatment With MOR03087 With/Without 
Dexamethasone 
1. Documented diagnosis of MM; specifically, relapsed or refractory MM defined as:  
• Failure of at least 2 previous therapies; previous therapies must include an 
immunomodulatory agent and a proteasome inhibitor (either together or as part of 
different therapies) 
• All subjects must have documented progression during or after their last prior therapy for 
MM 
2. Creatinine clearance ≥ 30 mL/min (calculated using the Cockcroft-Gault equation) 
3. Platelets:  
• ≥ 80 × 109/L, without previous transfusion within the last 4 weeks before first study drug 
administration  


Protocol: MOR202C101 
 
Page 17 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
• ≥ 50 × 109/L (for dose levels ≥4 mg/kg with or without DEX). Subjects are not allowed 
to have received platelet transfusion within the last 4 weeks before study drug 
administration. 
Additional Key Inclusion Criteria for the Treatment With MOR03087, Dexamethasone 
and Lenalidomide 
1. Documented diagnosis of MM; specifically, relapsed or refractory MM defined as:  
• Received at least 1 previous therapy 
• All subjects must have documented progression during or after their last prior therapy for 
MM 
2. Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault equation) 
3. Platelets: 
• ≥ 75 × 109/L for subjects in whom < 50% of bone marrow nucleated cells are plasma cells  
• ≥ 30 × 109/L for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma 
cells. 
Additional Key Inclusion Criteria for the Treatment With MOR03087, Dexamethasone 
and Pomalidomide 
1. Documented diagnosis of MM; specifically, relapsed and refractory MM defined as:  
• Received at least 2 previous therapies including LEN and a proteasome inhibitor 
• All subjects must have documented progression during or within 60 days after their last 
prior therapy for MM 
2. Creatinine clearance ≥ 45 mL/min (calculated using the Cockcroft-Gault equation) 
3. Platelets: 
• ≥ 75 × 109/L for subjects in whom < 50% of bone marrow nucleated cells are plasma cells 
• ≥ 30 × 109/L for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells 
3.3 Method of Treatment Assignment and Randomization 
The study is not randomized. Subjects are allocated to open cohorts only. The allocation is 
performed centrally by the project management. In case more than 1 cohort is open in parallel 
subjects who meet the inclusion-/exclusion criteria for more than 1 cohort are allocated to 1 of 
the open cohorts based on a specific cohort assignment plan. The project management department 
is the owner of the cohort assignment plan and the latest version is Version 6, 30-JUN-2016. 
3.4 Treatment Masking (Blinding)  
This is an open-label study. No personnel involved in the study will remain blinded. 
 
4. ANALYSIS AND REPORTING 
4.1 DMC Analysis 
An independent DMC will review the safety data at several timepoints during the study. Details 
of the safety data output provided for the DMC by Premier Research Biostatistics are described 
in a separate Statistical Interim Safety Analysis Plan, Final Version 4.0, dated 26-MAY-2015. 


Protocol: MOR202C101 
 
Page 18 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
4.2 Final Analysis 
The analyses identified in the protocol and in this SAP will be performed after all subjects 
enrolled have reached the Cycle 3 Day 1 visit or end of study assessments (whatever comes first) 
and all relevant study data have been processed, all relevant data has been frozen and this SAP 
has been approved. A cut-off date will be determined for the analysis (which will be after all 
subjects enrolled have reached Cycle 3 Day 1 or end of study assessments) and all data available 
up to the cut-off date will be included into the analysis. The final analysis is also referred to as 
“primary completion analysis”.  
4.3 Follow-up Analyses 
After the final analysis, additional supplemental analyses of long-term efficacy and safety 
follow-up will be performed. For this analysis, it is planned to re-run all analyses described in 
this SAP.  
Key statistics and study results will be made available to MorphoSys AG following database lock 
and prior to completion of the final CSR. 
Any, post-hoc, exploratory analyses completed to support planned study analyses, which were 
not identified in this SAP, will be documented and reported in appendices to the CSR. Any results 
from these unplanned analyses (post-hoc) will also be clearly identified in the text of the CSR. 
 
5. SAMPLE SIZE DETERMINATION 
A 3 + 3 design is used for the dose-escalation part of the study with confirmation cohorts of 
6 subjects. At least 9 subjects will be analyzed in the recommended dose groups of each part: 
6 subjects from the confirmation cohort and at least 3 subjects from the dose-escalation cohort 
who receive the same dose and regimen and combination treatment (if applicable). 
 
 
 
 
 
6. ANALYSIS POPULATIONS 
The following analysis populations are planned for this study: 
Total Population (All Subjects) 
The Total Population will consist of all subjects including screening failures.  
Safety Population 
The Safety Population will consist of all enrolled subjects who received any of the IMP at least 
once. 
DLT Evaluable Population 
The DLT Evaluable Population will consist of all enrolled subjects who have received at least 
1 cycle of MOR03087 (at least 4 doses for q1w or 2 doses for the q2w dosing schedule) 
(monotherapy or combination therapy) and if applicable per cohort, at least 16 doses of LEN or 
POM without dose modifications and who have minimum safety evaluations, including the first 


Protocol: MOR202C101 
 
Page 19 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
cycle and AEs reported from Day 1 after the start of the first infusion until Day 1 of the second 
cycle (before start of infusion).   
• 
Subjects who withdraw before having received the minimum number of infusions/doses 
and safety evaluations due to DLT will be included in the DLT evaluable population.  
• 
Subjects who discontinue study treatment or require a dose modification for LEN or POM 
for reasons unrelated to a DLT within the first cycle will be excluded from the DLT 
evaluable population. 
Efficacy Evaluable Population 
The Efficacy Evaluable Population will consist of all subjects who take at least 1 dose of IMP 
and who have at least one investigator response assessment (including potential unscheduled 
response assessment/ visits) after baseline. Only a post-baseline lab value without an Investigator 
response assessment does not qualify for inclusion. 
Pharmacokinetic Population 
The Pharmacokinetic Population will consist of all subjects who have sufficient pharmacokinetic 
data to characterize the time course of MOR03087 or LEN or POM in serum or plasma for the 
first IMP administration at a minimum. 
 
7. GENERAL ISSUES FOR STATISTICAL ANALYSIS 
7.1 General Statistical Methodology 
A table for disposition of all subjects (see section 8.1) will be produced for all subjects who 
provide informed consent, including screening failures. The Safety Population will be used for 
safety analysis and to analyze immunogenicity and the pharmacodynamic endpoints. The DLT 
Evaluable Population will be used to determine the maximum tolerated dose. Summaries for the 
analysis of tumor response will be provided for the Efficacy Evaluable Population and the Safety 
Population. Pharmacokinetic data evaluation will be not part of this SAP but described in a 
separate Pharmacokinetic Analysis Plan. 
Each safety listing will contain a flag indicating which subjects are DLT-evaluable and which 
subjects are not DLT-evaluable after the subject number. All listings will be sorted by cohort (if 
data from more than 1 cohort is presented).  
In the tables all available data of subjects including all cycles will be presented unless otherwise 
specified. For the AE tables presenting DLT, TEAEs by grading and SAEs, additional tables will 
be produced including data of the first cycle only. 
Tabulations of summary statistics, graphical presentations, and statistical analyses will be 
performed using SAS software, Version 9.4 or later. 
Continuous, quantitative variable summaries will include the number of subjects (N) (with non-
missing values), mean, standard deviation, median, minimum, maximum, and first and third 
quartiles. First and third quartile will not be shown in by-cohort-tables (tables of type 1, see 
section 7.2). 
Some of the descriptive summaries (as specified in the subsequent sections) will additionally 
include the 95%-confidence interval for the mean (absolute) change from baseline. The 


Protocol: MOR202C101 
 
Page 20 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
confidence interval will be calculated based on the quantiles of the t-distribution assuming 
normal distribution of the data. Moreover, some of the descriptive summaries (as specified in 
subsequent sections) will include the 95%-confidence interval for the median (absolute or 
percentage) change from baseline. The 95%-confidence interval for the median will be calculated 
without any assumption on the distribution of the data (nonparametric confidence interval). 
 
 
Categorical, qualitative variable summaries will include the frequency and percentage of subjects 
who are in a particular category. Unless otherwise stated the calculation of proportions will be 
based on the number of subjects of the analysis set of interest. Therefore counts of missing 
observations will be included in the denominator and presented as a separate category.  
 
 
 
The last pre administration observation will be used as the baseline value for calculating post 
administration changes from baseline. Thus baseline will be Cycle 1 Day 1 in case there is a 
value available (not missing) and screening otherwise. 
All data obtained on the electronic case report for (eCRF) and entered into the database will be 
provided in separate data listings showing individual subject values. The planning and reporting 
of statistical analyses will be carried out as described in the Premier Research Biostatistics 
standard operating procedures. 
Any subject who withdraws from the study will be analyzed with the data available. Imputation 
of missing values will not be performed. 
7.2 Structure of Tables 
Three different types of tables will be produced: 
1) tables for the total study data by cohort 
2) tables for the total study data by part  
• bi-weekly (Part A) 
• weekly without dexamethasone (Part B) 
• weekly with dexamethasone (Part C) 
• combination with POM (Part D) 
• combination with LEN (Part E) 
3) tables for recommended dose data by part 
• weekly with dexamethasone (Part C) 
• combination with POM (Part D) 
• combination with LEN (Part E) 
The safety and baseline summary tables will additionally contain a summary of the total number 
of subjects  of the corresponding analysis (sub-) group. 
In the tables for recommended dose data, all data from the recommended (or MTD) dose levels 
will be summarized together, i.e. data from the confirmation cohort will be combined with the 
data from the cohort of the dose escalation scheme that received the same dose and regimen and 
combination treatment (if applicable). 


Protocol: MOR202C101 
 
Page 21 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Summaries of type 2) and 3) will be referred to as combined presentations or combined data in 
subsequent sections, in contrast to summaries by dose level. 
The 95% confidence intervals will only be presented for these combined presentations and will 
not be presented by dose level due to the small number of subjects by dose level. 
7.3 Derived and Computed Variables 
The following derived and computed variables have been initially identified as important for the 
statistical analysis. Additional variables may be required. The SAP will not be amended for 
additional variables that are not related to the primary target or key secondary target variables. 
Any additional derived or computed variables will be identified and documented in the SAS 
programs that create the analysis files. If the SAP is not amended, further derivations related to 
primary and secondary target variables will be described in the CSR.  
7.3.1 Baseline Variables 
Table 1 shows the variables, which will be calculated for the analysis of subject disposition and 
baseline characteristics and to define subgroups based on baseline characteristics. 
Table 1: Derived Subject Disposition and Baseline Variables 
Data 
Variable 
Derivation 
Disposition 
time on study [months] 
Time on study will be calculated as time from 
Cycle 1 Day 1 until date of last visit or date of 
study completion whichever is later 
[= (date of last visit/study completion – 
Cycle 1 Day 1 + 1)/
] 
 
Time since first diagnosis of 
multiple myeloma [months] 
Time since first diagnosis will be calculated as 
time from date of first diagnosis until Cycle 1 
Day 1. If date of diagnosis is incomplete, time 
since first diagnosis [months] will be calculated 
based on the latest possible date for date of 
diagnosis. 
Previous 
Drug 
Treatment of 
MM 
Refractory to previous drug 
treatment [Yes/no/missing] 
Progression of disease while on a specific 
therapy, or within 60 days of completion of a 
given therapy.  
 (S. Lonial, Hematology 2010) [4] 
 
In case of incomplete dates mid of month 
(15th)/ mid of year (30JUN) will be used for 
date of end of previous therapy and/or date of 
progression. 
Each previous drug treatment of 1 therapy line 
should have the same date of progression. In 


Protocol: MOR202C101 
 
Page 22 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
case date of progression is missing for a 
treatment or different dates are entered, the 
latest date of progression will be used for all 
treatments of this therapy line. 
In case date of progression or date of end of 
previous therapy is completely missing or 
progression status is not determined at all for 
previous therapies (e.g. subjects enrolled at the 
beginning of the study), variable will be 
missing 
This variable will be determined for each 
previous drug treatment. 
 
Refractory to most recent 
previous drug treatment line 
[Yes/no/missing] 
The most recent drug treatment will be selected 
based on most recent end date. Refractory will 
be determined as described above.  
This variable will be determined per subject. 
 
Double-Refractory 
to 
previous drug treatments 
containing a proteasome 
inhibitor 
and 
IMiD 
[Yes/no/missing] 
Refractory to a proteasome inhibitor and 
refractory to an IMiD. 
Refractory will be determined as described 
above. 
Cytogenetics of 
MM 
Cells 
(Bone Marrow) 
 
high 
risk 
evaluation 
[Yes/no/missing] 
Reference: Chng et al., Leukemia, 2014 [5] 
high risk is met [Yes] if a subject has  
 (1) 
chromosomal 
aberration 
t(4;14) 
or 
Del17p13and  
(2) International Staging System (ISS) criteria  
II/III 
In case chromosomal aberations and/or ISS are 
not determined or one chromosomal aberation 
is missing and the other one is absent, variable 
will be missing. 
 
7.3.2 Immunogenicity 
Subject has positive anti-MOR03087 antibodies (yes/no/missing) by visit:  
• yes, if a titer is available (in this case the sample is confirmed positive) 
• no, if result is reported as negative 
• missing, if anti-MOR03087 measurement is not available 
Subject 
has 
developed 
positive 
anti-MOR03087 
antibodies 
during 
study 


Protocol: MOR202C101 
 
Page 23 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
(yes/no/transient/not evaluable/missing):  
• yes, if the subject has at least 1 confirmed positive post-baseline sample containing 
anti-MOR03087 antibodies including the last sample analyzed; baseline sample has to be 
tested negative 
• no, if baseline as well as all post-baseline results are negative 
• transient, if the subject has at least 1 confirmed positive post-baseline sample containing 
anti-MOR03087 antibodies but a negative result for the last sample analyzed; baseline 
sample has to be tested negative 
• not evaluable, if the baseline sample of the respective subject was tested positive 
• missing, if no post-baseline anti-MOR03087 measurement is available 
Time to development of anti-MOR03087 antibodies [months]: Time to development of 
anti-MOR03087 antibodies will be defined as time from Cycle 1, Day 1 until Date of first blood 
sample containing anti-MOR03087 antibodies. Subjects who do not develop any antibodies by 
end of study will be considered as censored at the date of last blood sample taken for MOR03087 
antibody analysis. 
7.3.3 Efficacy Endpoints Based on Investigator Assessment 
The Investigator will assess efficacy at specific study visits according to the response criteria for 
MM as defined in section 18.3 of the study protocol version valid at the time of the assessment. 
All of the criteria are based on the International Myeloma Working Group (IMWG) Uniform 
Response Criteria [6], except for MR, which is based on the (adopted) European Group for Blood 
and Marrow Transplantation (EBMT) criteria [7].  
The response evaluation of the Investigator is based on the serum and urine M-protein levels, 
and, where applicable, the serum FLC level, and FLC ratio.  
The categories of overall tumor response assessment of the Investigator will be as follows: 
• sCR – Stringent Complete Response 
• CR - Complete Response 
• VGPR - Very Good Partial Response 
• PR - Partial Response 
• MR - Minimal Response 
• SD - Stable Disease 
• PD - Progressive disease 
• Missing (if response assessment is not done) 
In case of progressive disease, the date of progression will be given by the Investigator. 
All responses need 2 consecutive assessments, ideally being confirmed at Day 1 of the next cycle. 
Thus all endpoints defined to evaluate responses per-subject across time points (see section 
7.3.3.2 and 7.3.3.3) will include confirmed responses only. 
For all endpoints where dates are used in the derivations (e.g. date of first response, date of first 


Protocol: MOR202C101 
 
Page 24 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
progression), the following dates will be taken into consideration to determine the time point 
each response assessment refers to: 
• Date of assessment or date of visit, whichever is earlier  if the assessment is non-PD (this 
approach is chosen as the assessment is sometimes done retrospectively and not at the 
date of the visit) 
• date of progression given by the Investigator in the field “Date of Progression” in the 
response assessment form if the assessment is PD 
In case any non-study anti-MM treatments are given before end of study (see also section 8.3, it 
is regarded as protocol non-compliance. Tumor assessments after start of non-study anti-MM 
treatment will not be taken into account for any of the derived efficacy variables described below. 
In case the start date of non-study anti-MM treatment is incomplete, an imputed start date will 
be used in all derivations. The imputed start date will always be the first possible start date, but 
after the end-of-study (EOS) visit. For example, in case day is missing, but month and year are 
complete, the first day of the month will be taken if after EOS, otherwise date of EOS + 1. 
7.3.3.1 
Responses by subject and visit 
The following variables will be derived by visit based on the overall tumor assessment of the 
Investigator: 
Any response (PR or better) (yes/no) by visit:  
• yes, if tumor response assessment is sCR, CR, VGPR, or PR 
• no, if tumor response assessment is MR, SD, PD or Missing 
Any clinical benefit (MR or better) (yes/no) by visit:  
• yes, if tumor response assessment is sCR, CR, VGPR, PR or MR 
• no, if tumor response assessment is SD, PD or Missing 
Any disease control (SD or better) (yes/no) by visit:  
• yes, if tumor response assessment is sCR, CR, VGPR, PR, MR or SD 
• no, if tumor response assessment is PD or Missing 
7.3.3.2 
Responses derived per-subject across time points: 
The subsequent variables will be derived per-subject across time points, based on the overall 
tumor assessment of the Investigator. 
Best Overall Response (BOR): The best overall response will be defined as the best response 
across all time points. The best possible overall response is sCR, followed by CR, VGPR, PR, 
MR, SD, and PD.  
To be assigned a status of sCR, CR, VGPR, PR, MR, SD, the first assessment must be confirmed 
by the next consecutive non-missing assessment (missing values will not be taken into account). 
Both assessments must show a status of sCR, CR, VGPR, PR, MR or SD, and the assigned 
confirmed status will be the weaker status of both assessments. 
A single progression of disease (PD) assessment which did not cause a discontinuation of 


Protocol: MOR202C101 
 
Page 25 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
treatment and which has been disproven by the next consecutive non-missing tumor assessment 
will not be considered in the evaluation of best overall response. If no post-baseline confirmed 
response assessment or PD is available, then the best overall response will be “Not Evaluable” 
(NE). 
Secondary efficacy endpoint variables: 
Any response (yes/no) in study: 
• yes, if best overall response is sCR, CR, VGPR or PR 
• no, if best overall response is MR, SD, PD or NE 
The Overall response rate (ORR), defined as the proportion of subjects who meet the criteria 
of confirmed sCR, CR, PR or VGPR at any time during study, will be calculated from this 
variable. 
Additional efficacy variables: 
Any clinical benefit (yes/no) in study: 
• yes, if best overall response is sCR, CR, VGPR, PR or MR 
• no, if best overall response is SD, PD or NE 
The Clinical benefit rate (CBR), defined as the proportion of subjects who meet the criteria of 
confirmed CR, PR, VGPR or MR at any time during study, will be calculated from this variable. 
Any disease control (yes/no) in study: 
• yes, if best overall response is sCR, CR, VGPR, PR, MR or SD 
• no, if best overall response is PD or NE 
The Disease control rate (DCR) defined as the proportion of subjects who meet the criteria of 
confirmed sCR, CR, VGPR, PR, MR or SD at any time during study, will be calculated from this 
variable. 
7.3.3.3 
Time-related efficacy endpoints 
With respect to the time-related efficacy endpoints defined subsequently, a single PD assessment 
which did not cause a discontinuation of treatment and which has been disproven by the next 
consecutive non-missing tumor assessment will not be considered when determining the date of 
first progression and the censoring variables.  
Thus, the date of progression used for the derivations will be the date of progression related to 
the first PD assessment that fulfills at least 1 of the following criteria:  
• 
the next consecutive non-missing tumor assessment is also PD 
• 
the PD assessment is the last tumor assessment in the study 
The start date for sCR, CR, VGPR, PR, MR and SD is defined as the date of the first time point 
at which the response was noted, provided that the response was confirmed at a later time point 
(as described in section 7.3.3.2). However, a response followed by ≥ 2 non-confirming 
consecutive non-missing planned response assessments will not be considered for the 
determination of the first date at which the response was noted. 


Protocol: MOR202C101 
 
Page 26 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
The date of death due to progression is the stop date of AEs with a fatal outcome and a preferred 
AE term “Disease progression” or “Multiple myeloma”.    
All time-related efficacy endpoints defined below will be reported in months. 
Secondary efficacy endpoint variables: 
Duration of response (DoR): The duration of response will be calculated in the subgroup of 
subjects showing confirmed sCR, CR, VGPR or PR. Duration of response will be defined as the 
time from date of first response (sCR, CR, VGPR or PR) until date of progression or death due 
to progression (as defined above) whichever is documented first. For censoring rules see Table 
2.  
Time to progression (TTP): Time to progression will be defined as the time from Cycle 1, Day 1 
until date of progression or death due to progression (as defined above) whichever is documented 
first. For censoring rules see Table 2.  
Table 2: Censoring Rules for DoCB, DoR and TTP 
 
Progression-free survival (PFS): Progression-free survival will be defined as the time from 
Situation 
 
Date of Progression or Censoring 
Outcome 
Disease Progression 
Date of progression 
Progressed 
No baseline tumor assessment 
Date of first treatment 
Censored 
No disease progression 
Date of last tumor assessment 
Censored 
Subject received non-study MM 
treatment before disease 
progression 
Date of last tumor assessment prior to 
non-study treatment 
Censored 
Death from other causes than 
disease progression, without 
documented disease progression 
before 
Date of last tumor assessment 
Censored 
Death caused by disease 
progression between adequate 
assessments  
Date of death 
Progressed 
Death caused by disease 
progression or progression after  
> 65 days (2x 29-day cycle +7 
days) after last tumor response 
assessment (representing the time 
interval of 2 or more consecutive 
missed tumor response 
assessments)  
Date of last tumor assessment 
Censored 


Protocol: MOR202C101 
 
Page 27 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Cycle 1, Day 1 until date of progression (as defined above) or date of death, whatever occurs 
earlier, or date of censoring (as defined below). For censoring rules see Table 3. 
 
Table 3: Censoring Rules for PFS 
 
Additional time to event variables: 
Duration of clinical benefit (DoCB):  The duration of clinical benefit will be calculated in the 
subgroup of subjects showing confirmed sCR, CR, VGPR, PR or MR. Duration of clinical benefit 
will be defined as the time from date of first clinical benefit (sCR, CR, VGPR, PR or MR) until 
date of progression or death due to progression (as defined above), whichever is documented 
first. For censoring rules see Table 2.  
Additionally, the DoR of sCR/CR and sCR/CR/VGPR according to the above defined rules will 
be reported separately. 
Time to next treatment (TTNT): TTNT will be defined as the time from Cycle 1, Day 1 until 
start date of new anti-MM treatment as documented at the end of trial visit under “Subsequent 
anti-MM Treatment” or date of death. Subjects with no documented start date for a subsequent 
anti-MM treatment and no documented date of death will be considered censored using the date 
of the last visit.  
Situation 
 
Date of Progression or Censoring 
Outcome 
Disease progression 
Date of progression 
Progressed 
No post-baseline tumor 
assessment 
Date of first treatment 
Censored 
No disease progression 
Date of last tumor assessment 
Censored 
Subject received non-study MM 
treatment before disease 
progression 
Date of last tumor assessment prior to 
non-study treatment 
Censored 
Death before any date of PD 
assessment 
Date of death 
Progressed 
Death between adequate 
assessments 
Date of death 
Progressed 
Death or progression after 
> 65 days (2x 29-day cycle +7 
days) after last tumor response 
assessment (representing the time 
interval of 2 or more consecutive 
missed tumor assessments)  
Date of last tumor assessment 
Censored 


Protocol: MOR202C101 
 
Page 28 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Event-free survival (EFS): EFS will be defined as the time from Cycle 1, Day 1 until date of 
progression, date of death, or date of discontinuation of treatment for any reason (e.g. toxicity, 
subject preference, or initiation of a new treatment without documented progression), whichever 
occurs earlier. Subjects still on treatment, without disease progression, will be censored at the 
date of the last available tumor assessment. 
Additional time to event variables for the subgroup of responders: 
Time to first response: Time to first response will be defined as the time from Cycle 1, Day 1 
until start date of first response (sCR, CR, VGPR or PR).  
Time to best response: Time to best response will be defined as the time from Cycle 1, Day 1 
until best response (sCR, CR, VGPR or PR).  
Time to first clinical benefit: Time to first clinical benefit will be defined as the time from 
Cycle 1, Day 1 until first clinical benefit (sCR, CR, VGPR, PR or MR).   
7.3.4 Quantitative Efficacy Variables based on Serum or Urine M-Protein, and/or Serum 
FLCs 
Serum and urine M-protein and serum FLCs were analyzed by a local laboratory at the beginning 
of the study and by central laboratory for subjects enrolled after Nov 2014 (starting from cohort 
7c/ cohort 8 partially) using the response criteria for MM as defined in the current version of the 
protocol. The following parameters will be measured by visit: 
 
• Serum M-protein level [g/L] 
o Measurements are given g/L, g/dL, mg/L or mg/dL. All values will be converted 
to [g/L].  
• Urine M-protein result [g/24h] 
o Measurements are given g/24h or mg/24h. All values will be converted to [g/24h].  
• Lambda FLCs [mg/L] 
o Values smaller than the limit of quantification will be analyzed with the value for 
the limit of quantification. 
• Kappa FLCs [mg/L] 
o Values smaller than the limit of quantification will be analyzed with the value for 
the limit of quantification. 
• Kappa/lambda FLC ratio  
o Kappa/lambda FLC ratio will be recalculated by biostatistics.  
 
For all of these parameters, absolute and percentage changes from baseline will be calculated by 
visit.  
Moreover, the following variables will be derived per subject across timepoints:  
Relative change (%) in serum M-protein level from baseline to post-baseline nadir: 
This variable will be calculated for all subjects that have measurable serum M-protein levels at 
baseline and at least 1 post-baseline serum M-protein measurement. The post-baseline nadir will 


Protocol: MOR202C101 
 
Page 29 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
be the smallest serum M-protein level recorded after baseline. The relative change (%) will be 
derived as follows:   
100* (serum M-protein level at post-baseline nadir – baseline serum M-protein level) / (baseline 
serum M-protein level). 
Relative change (%) in urine M-protein result from baseline to post-baseline nadir: 
This variable will be calculated for all subjects that have measurable urine M-protein results at 
baseline and at least 1 post-baseline urine M-protein measurement. The post-baseline nadir will 
be the lowest urine M-protein result recorded after baseline. The relative change (%) will be 
derived as follows:   
100* (urine M-protein result at post-baseline nadir – baseline urine M-protein result) / (baseline 
urine M-protein result). 
 
In case any new anti-MM treatments are given before end of study (see also section8.3), this will 
be regarded as protocol non-compliance. M-protein values measured after start of new anti-MM 
treatment will be flagged in listings. Moreover, these will be excluded from tables and will not 
be taken into account when deriving relative changes from baseline to post-baseline nadir. 
7.3.5 Quality of Life 
Quality of life (QoL) will be assessed using the Quality of Life Questionnaire for Cancer Subjects 
(QLQ-C30) (version 3) [8] and the Quality of Life Questionnaire for Myeloma Subjects 
(QLQ-MY20) [9], [10] developed by the European Organisation for Research and Treatment of 
Cancer (EORTC).  
The QLQ-C30 instrument is a reliable and validated 30-item questionnaire composed of 
5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, 
nausea and vomiting, and pain) and a global health status/quality of life scale, and 6 single 
symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). 
The QLQ-MY20 instrument is a 20-item disease-specific modular questionnaire regarding 
subject-reported symptoms or problems. It is usually completed in addition to the QLQ-C30 
questionnaire. 
The QLQ-C30 will be scored as described in the EORTC QLQ-C30 Scoring Manual from the 
EORTC Data Center (2001) [11]. The QLQ-MY 20 will be scored according to the same 
principles as described in the addendum: scoring instructions for newly validated modules. 
A score will be calculated for all scales (categories) shown in Table 4. 
Table 4 Scales for Scoring the QLQ-C30 (version 3.0) and QLQ-MY 20 
 
 
Number 
of items 
Item 
Range* 
Item numbers 
(Version 3.0) 
QLQ-C30 
(Item Numbers 
1-30) 
Global health status / QoL 
 
 
 
Global health status/QoL  
2 
6 
29, 30 
Functional scales 
 
 
 
Physical functioning 
5 
3 
1 to 5 
Role functioning 
2 
3 
6, 7 
Emotional functioning 
4 
3 
21 to 24 
Cognitive functioning 
2 
3 
20, 25 
Social functioning 
2 
3 
26, 27 


Protocol: MOR202C101 
 
Page 30 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
Number 
of items 
Item 
Range* 
Item numbers 
(Version 3.0) 
Symptom scales / items 
 
 
 
Fatigue 
3 
3 
10, 12, 18 
Nausea and vomiting 
2 
3 
14, 15 
Pain 
2 
3 
9, 19 
Dyspnea 
1 
3 
8 
Insomnia 
1 
3 
11 
Appetite loss 
1 
3 
13 
Constipation 
1 
3 
16 
Diarrhea 
1 
3 
17 
Financial difficulties 
1 
3 
28 
QLQ-MY 20 
(Item Numbers 
31-50) 
Functional scales / items 
 
 
 
Future perspective 
3 
3 
48 – 50 
Body image 
1 
3 
47 
Symptom scales 
 
 
 
Disease symptoms 
6 
3 
31 –36 
Side effects of treatment 
10 
3 
37 – 46** 
*Item range is the difference between the possible maximum and the minimum response to individual items; 
functional and symptom scales take values from 1 =Not at all to 4= Very Much, resulting in range = 3. Questions 
regarding global health status take values from 1 to 7, resulting in range =6. 
** Question 42 is considered scored “not at all” if question 41 is scored “not at all”. 
For all scales (categories), the Raw Score (RS) is the mean of the component items. 
In case of missing items within an answered questionnaire, the RS for the scale will only be 
calculated if at least half of the items from the scale have been answered. In this case the mean 
will be calculated only including those questions which have been answered. 
The RS will be transformed into a standardized score using a linear transformation so that scores 
range from 0 to 100; a higher standardized score represents a higher ("better") level of functioning 
for functional scales, or a higher ("worse") level of symptoms for symptom scales. The following 
formula will be used for transformation: 
 
• Functional scales: Score = [1- (RS-1)/range]*100 
• Symptom scales: Score = (RS-1)/range *100 
 
A global score based upon the sum of all items of the QLQ-C30 and/or the QLQ-MY20 will not 
be calculated according to the recommendations of the EORTC data center. The Global health 
status / QoL scale (based on questions 29 and 30) will be used as an overall summary measure 
for the QLQ-C30. 
7.3.6 Exposure 
Table 5 shows the variables that will be calculated to measure exposure to study drugs 
(MOR03087, DEX, LEN, POM). Exposure to MOR03087 will be calculated for all subjects, 
exposure to LEN and POM will be only calculated for subjects in the respective combination 
therapy cohorts. Dexamethasone exposure will be derived for subjects in the dose-escalation part 


Protocol: MOR202C101 
 
Page 31 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
receiving weekly MOR03087 treatment plus dexamethasone, and in subjects in both combination 
therapy cohorts. In cohorts where dexamethasone may be added later, dexamethasone intake will 
be summarized within the concomitant medication table.  


Protocol: MOR202C101 
 
Page 32 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Table 5 Derived Variables for Exposure 
Exposure to Any Study Drug 
Variables calculated 
on a per-subject basis  
Duration of treatment 
[months] 
(date of last dosing day of any IMP – date of 
first dosing day of any IMP + 1)/
 
Exposure to MOR03087 
Variables calculated 
for each study drug 
administration 
Percentage of actual 
volume administered vs. 
planned volume [%] 
Actual volume administered [mL]/planned 
volume [mL]*100% 
Note: The planned volume is either 100 mL 
or 250 mL. 
In case no actual volume administered is 
given, the value will be set  
• 
to the planned volume in case dosing 
modified is answered with “No” 
• 
to 0 in case dosing modified is 
answered with “Yes” and the type of 
modification is “Infusion not given” 
• 
to 0 in case infusion page is not 
filled out, but visit took place, and 
infusion planned according to 
treatment schedule and visit date is 
before last date of dosing  
• 
to missing in case dosing modified is 
answered with “Yes” and type of 
modification is other than “Infusion 
not given”. 
In case actual volume is 0 and planned 
volume is unknown, the percentage will still 
be calculated as 0%. 
 
Actual dose administered 
[mg/kg] 
(Actual volume administered [mL]/planned 
volume [mL])*Assigned dose [mg/kg]  
Note: This calculation assumes that the study 
drug solution is prepared correctly and 
contains the correct amount of study drug. 
 
Actual dose administered 
[mg] 
(Actual volume administered [mL]/planned 
volume [mL])*Assigned dose [mg/kg]* 
Weight[kg] 
Note: Weight will be taken from the same 
visit from the Vital Signs form. In case no 
weight is available for this visit the most 
recent previous available weight will be 


Protocol: MOR202C101 
 
Page 33 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
taken.  
 
Duration of infusion [min] 
Duration, calculated as stop time of infusion 
– start time of infusion  
 
Duration of infusion 
[categorized] 
Duration will be categorized into: <40min; 
<1h, <2h; <3h; ≥3h 
Variables calculated 
on a per-subject basis 
including data of all 
cycles 
Number of cycles initiated 
Number of cycles initiated per subject 
according to the following definition: 
A cycle will be qualified as “initiated” if at 
least 1 dose (non null) of study drug was 
administered in this cycle. 
 
Number of cycles 
completed 
Number of cycles completed = number of 
cycles initiated, in case a subject drops out at 
the end of a cycle (i.e. at Day 22 or later, 
with last infusion at Day 22 administered in 
case of weekly treatment), but before start of 
next cycle. 
Number of cycles completed = number of 
cycles initiated – 1, in case a subject drops 
out within the last cycle.  
 
Number of cycles with all 
infusions completed 
Number of cycles with all infusions 
completed (i.e. study drug administration 
page is filled for all intended infusions of the 
cycle and it is not ticked “Infusion not 
given”.) 
 
Number of infusions 
administered  
Number of all infusions where a study drug 
administration page is filled and it is not 
ticked “Infusion not given”. 
 
Percentage of infusions 
administered 
Number of infusions administered/ Number 
of planned infusions from Cycle 1, Day 1 up 
to and including the last visit for which the 
question “Was treatment modified” was 
answered (in any form). 
 
Number of infusions 
administered with any 
modification 
Number of all infusions with any treatment 
modification except “Infusion not given”. 
 
Average percentage of 
actual volume 
administered vs. planned 
volume [%] 
Mean of the variable “Percentage of actual 
volume administered vs. planned volume 
[%]” over all infusions  
 
Total actual dose 
Sum of the variable “Actual dose 


Protocol: MOR202C101 
 
Page 34 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
administered [mg/kg] 
administered [mg/kg]” over all infusions  
 
Total actual dose 
administered [mg] 
Sum of the variable “Actual dose 
administered [mg]” over all infusions  
 
Average actual dose 
administered [mg/kg] 
Mean of the variable “Actual dose 
administered [mg/kg]” over all infusions  
 
Number of infusions not 
given 
 
Number of all infusions with “Actual volume 
administered [mL]” of zero. 
Missing data will be replaced as described 
above. 
 
Percentage of infusions 
not given [%] 
Number of infusions not given / Number of 
planned infusions from Cycle 1, Day 1 up to 
and including the last visit for which the 
question “Was treatment modified” was 
answered (in any form) 
 
Shortest infusion duration 
category per subject 
Select from all available infusion duration 
categories per subject the shortest one in the 
order of <40min; >=40 min to <1h; >= 1h to 
<2h; >= 2h to <3h, and ≥3h 
Exposure to Lenalidomide 
Variables calculated 
on a per-subject basis 
including data of all 
cycles 
Number of days treated  
Sum of durations of intake [=Start date – Stop 
date + 1] over all entries (in the eCRF LEN 
administration log) with non-zero dose 
 
Total actual dose taken 
[mg] 
Sum of (durations of intake * dose [mg]) over 
all entries (in the eCRF LEN administration 
log)  
 
Average daily dose taken 
during days treated 
[mg/day] 
Total actual dose taken [mg]/ Number of days 
treated 
 
Average daily dose taken 
during study [mg/day] 
Total actual dose taken [mg]/ Duration of 
treatment [weeks] *7 
 
Percentage of actual dose 
vs. planned dose [%] 
Total actual dose taken [mg]/ Planned dose 
[mg] 
Where planned dose = sum of (starting dose of 
each cycle * 21 days), calculated over all 
cycles initiated. Starting dose of each cycle is 
taken from eCRF LEN administration page for 
Day 1 of each cycle 


Protocol: MOR202C101 
 
Page 35 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
Number of days with 
missed doses  
Sum of durations of intake of 0 dose [=Start 
date – Stop date + 1] over all entries (in the 
eCRF LEN administration log) with reason 
other than “Subject is in Rest Period between 
Day22 and Day28” 
 
Any dose reduction 
Any reduced dose applications (compared to 
starting dose in first cycle)  
 
Any permanent 
discontinuation of LEN 
but continuation of 
MOR03087 
Discontinuation of LEN but continuation of 
MOR03087 during at least 2 MOR03087 
infusions until last MOR03087 dosing day 
Exposure to Pomalidomide 
Variables calculated 
on a per-subject basis 
including data of all 
cycles 
Number of days treated  
Sum of durations of intake [=Start date – Stop 
date + 1] over all entries (in the eCRF POM 
administration log) with non-zero dose  
 
Total actual dose taken 
[mg] 
Sum of (durations of intake * dose [mg]) over 
all entries (in the eCRF POM administration 
log)  
 
Average daily dose taken 
during days treated 
[mg/day] 
Total actual dose taken [mg]/ Number of days 
treated 
 
Average daily dose taken 
during study [mg/day] 
Total actual dose taken [mg]/ Duration of 
treatment [weeks] *7 
 
Percentage of actual dose 
vs. planned dose [%] 
Total actual dose taken [mg]/ Planned dose 
[mg] 
Where planned dose = sum of (starting dose of 
each cycle * 21 days), calculated over all 
cycles initiated. Starting dose of each cycle is 
taken from eCRF POM administration page 
for Day 1 of each cycle 
 
Number of days with 
missed doses  
Sum of durations of intake of zero dose 
[=Start date – Stop date + 1] over all entries 
(in the eCRF POM administration log) with 
reason other than “Subject is in Rest Period 
between Day22 and Day28” 
 
Any dose reduction 
Any reduced dose (compared to starting dose 
in first cycle)  
 
Any permanent 
Discontinuation of POM but continuation of 


Protocol: MOR202C101 
 
Page 36 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
7.4 Subgroups Used for Efficacy Analysis 
For efficacy analyses the following subgroups will be defined: 
• Age: < 65 years / ≥ 65 years 
• Age: ≤ 75 years / > 75 years 
• Prior therapy lines: ≤ median / > median (Note: median will be determined in total safety 
population) 
• High risk cytogenetics: Yes / No 
• Sex: Male / Female 
• ISS: I or II / III 
• Percentage of plasma cells in bone marrow at screening: < 60 / ≥ 60 
• Subjects refractory to  
o Proteasome inhibitors (PIs) and Immunomodulatory Drugs (IMiDs) 
o any IMiDs only (not refractory to any PIs, but allowed to be refractory to any 
other previous drug) 
o any PIs only (not refractory to any IMiDs, but allowed to be refractory to any other 
previous drug) 
discontinuation of POM 
but continuation of 
MOR03087 
MOR03087 during at least 2 MOR03087 
infusions until last MOR03087 dosing day 
Exposure to Dexamethasone 
Variables calculated 
on a per-subject basis 
including data of all 
cycles 
Number of applications 
Number of DEX intakes where a study drug 
administration page is filled and the question 
“Was dexamethasone taken?” is answered 
with “Yes”. 
 
Total actual dose taken 
[mg] 
Sum over all doses administered 
 
Average actual dose 
taken during days treated 
[mg] 
Total actual dose taken [mg]/ number of 
intakes 
 
Number of infusion days 
without administration of 
DEX 
Number of all MOR03087 infusions where a 
study drug administration page is filled out 
and it is not ticked “Infusion not given” but 
DEX is not taken  
 
Any dose reduction 
Any reduced dose (compared to starting dose 
in first cycle)  
 
Any permanent 
discontinuation of DEX 
but continuation of 
MOR03087 
Discontinuation of DEX but continuation of 
MOR03087 during at least 2 MOR03087 
infusions until last MOR03087 dosing day 


Protocol: MOR202C101 
 
Page 37 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
o last prior treatment line Yes / No 
o any prior treatment line Yes / No 
 
 
 


Protocol: MOR202C101 
 
Page 38 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
8. STUDY SUBJECTS AND DEMOGRAPHICS 
8.1 
Disposition of Subjects and Withdrawals 
All subjects who provide informed consent will be included in the database and will thus be 
accounted for in this study. Descriptive summaries of population data will be presented for the 
total population and the safety population and will include  
• The frequency and percent of subjects in each study population  
• The disposition of subjects including  
o number of subjects screened, who failed screening and who are eligible 
o number of subjects treated  
o number of subjects who completed 1st treatment cycle (subjects with number of 
cycles completed >=1, see definition in section 7.3.6) 
o number of subjects who completed of 2nd treatment cycle (subjects with number 
of cycles completed >=2, see definition in section 7.3.6) 
o number of subjects with at least one Cycle 3+ treatment 
o number of subjects who terminated the study 
o number of subjects still ongoing 
• Study discontinuations for all subjects treated by reason (as specified in eCRF) (safety 
population only) 
• time on study [months] and duration of treatment [months] (see definition in 
section 7.3.6) 
Moreover, a listing of screening failures with corresponding reasons will be provided. 
8.2 Protocol Non-compliances 
Evaluability of subjects according to the definition of the DLT evaluable population is checked 
on an ongoing basis by the clinical study team of Premier Research. If a subject is non-evaluable, 
a new subject will be enrolled and will need to meet the definition for the DLT evaluable 
population before DMC review, to have the required number of DLT evaluable population 
subjects. The information that indicates why subjects are not evaluable together, with the reason 
for the exclusion from the DLT evaluable population, will be provided by the clinical study team 
to biostatistics before each DMC review.  
For the final analyses, the DLT evaluable population will be defined according to the decisions 
for inclusion/exclusion at the time of the DMC meeting.  
Exclusions from the other analysis populations will be checked programmatically according to 
the definition of the analysis population, but will be reviewed case-by-case before data release 
for final analysis.  
Individual subjects with their reasons for exclusion from any analysis population will be listed. 
 


Protocol: MOR202C101 
 
Page 39 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
The clinical non-compliance tracker will be displayed separately in the appendix of the clinical 
study report. 
8.3 
Demographics and Other Baseline Characteristics 
Descriptive summaries of the demographic and other baseline characteristics will be completed 
for the safety population. 
Descriptive summaries of demographic and other baseline conditions will include: 
• Demographics (age [both as a continuous variable and as number of subjects aged 
< 65 and aged ≥ 65, aged ≤ 75 and aged > 75 as well as 18-64, 65-84 and >= 85 
years], gender, race, height, weight at screening, body mass index [BMI]) 
• Medical history 
• Disease staging based on Durie-Salmon (including subclassifications A and B) 
and on ISS Criteria  
• Previous non-drug and drug treatment of multiple myeloma  
• Time since first diagnosis of multiple myeloma [months] 
• Cytogenetics of MM cells (bone marrow) 
• DNA analysis of FcγRIIIa polymorphism (mucosal cheek swab)  
• Concomitant medication  
 
Medical History: Note that medical history will be coded with Medical Dictionary for Regulatory 
Activities (MedDRA Version 20.1, and updated to the newest version 23.0 for the follow-up 
analyses). Incidences of findings in medical history will be summarized by system organ class 
(SOC) and preferred term. 
Disease Staging Based on Durie-Salmon (including subclassification A or B), and on ISS 
Criteria: Disease staging will be summarized descriptively by main classification (I/II/III) and 
by subclassification as applicable separately for both staging criteria. 
Previous Non-Drug/Drug Treatment: Previous non-drug treatment will also be coded with 
MedDRA. The following groups will be defined for previous non-drug treatment: stem cell 
transplantation, radiotherapy, other. Incidences of previous non-drug treatments will be 
summarized by group. 
Previous drug treatment will be coded using the WHO Drug Dictionary (March 2011, and 
updated to the newest version March 2020 for the follow-up analyses). Based on preferred term 
and coding levels of the WHO Drug Dictionary, previous drug treatments will be allocated to the 
following groups and subgroups: 
• Group “Cytotoxic agents” with subgroups “Alkylating agents”, “Antimetabolites”, 
“Alkaloids”, “Anthracycline agents”, “Platinum compounds” and “Other cytotoxic 
compounds” 
• Group “Other agents” with subgroups “Antibodies”, “Protein kinase inhibitors”, 
“Proteasome inhibitors”, “HDAC inhibitors”, “Interferons, “Immunomodulatory drugs”, 


Protocol: MOR202C101 
 
Page 40 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
“Glucocorticoids”, “Other antineoplastic agents”, “Other”  
Incidences of previous drug treatments will be summarized by group, subgroup and agent. 
Moreover the number of previous lines of therapy (as entered into the eCRF) will be summarized 
descriptively (summary statistics and frequency table). The frequency table will contain 
cumulative subcategories, i.e. number of subjects with >= x prior therapy lines, for all possible 
numbers x. 
Best response under treatment and type of progression associated with each previous drug 
treatment will be included in listings. 
Moreover, it will be determined for each previous drug treatment if the subject was refractory to 
the treatment (see section 7.3.1).  
Incidences of previous drug treatments to which subjects were refractory will be summarized by 
group, subgroup and agent. 
In addition, the rate of subjects who were refractory to the most recent drug treatment line and 
the rate of subjects who were double-refractory will be presented. 
Time Since First Diagnosis of Multiple Myeloma [Months]: Time since first diagnosis will be 
measured from date of first diagnosis until Cycle 1 Day 1.  
Cytogenetics of MM Cells (Bone Marrow): The frequency of translocations t(4;14) and t(14;16) 
and deletions Del13 and Del17p13 and other documented cytogenetic abnormalities (measured 
at screening or known from historical data) will be summarized descriptively in a frequency table 
(categories: yes/no/missing/not tested). Moreover, the table will contain frequencies for high risk 
evaluation (see section 7.3.1).  
DNA Analysis of FcγRIIIa Polymorphism (Mucosal Cheek Swab): The frequency of each 
genotype (158FF, 158VF, 158VV, other, missing) will be summarized descriptively in a 
frequency table. 
Concomitant Medication: All medications will be coded using the WHO Drug Dictionary (March 
2011, and updated to the newest version March 2020 for the follow-up analyses). Incidences of 
concurrent medications will be summarized by Anatomical Therapeutic Chemical (ATC) level 2 
and ATC level 4.  
Concomitant medication is defined as a medication other than study drug that was administered 
during the treatment or follow-up period from day of first treatment up to the end of study.  
Therefore entries of medications which were discontinued before start of treatment will be 
excluded from concomitant medication tables but will be included and flagged in the listings as 
previous medications. 
If the start/stop dates of medication are partially or completely missing a medication will be 
assumed to be concomitant if it cannot be definitely shown that the medication was not 
administered during the treatment or follow-up period. Missing dates will not be replaced.  
Thus, the following approach will be taken for exclusion from concomitant medication because 
of discontinuation before start of treatment: 


Protocol: MOR202C101 
 
Page 41 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
• If stop day is missing but month is complete, medication will only be excluded from 
concomitant medication if stop month is before month of treatment start. 
• If stop day and month are missing but year is complete, medication will only be excluded 
from concomitant medication if stop year is before year of treatment start. 
• If stop date is completely missing and/or medication is specified as “ongoing”, 
medication will not be excluded 
Anti-MM Treatments During Study: If a subject receives any anti-MM treatment other than the 
IMP(s) during study, it is regarded as protocol non-compliance. Introduction of new anti-MM 
treatment should result in exclusion of the subject from further study participation. 
Subsequent Anti-MM Treatments: The first subsequent anti-MM treatment planned and the 
corresponding start date will be captured in the eCRF, for subjects included based on protocol 
amendment 6 or afterwards.  
Subsequent anti-MM treatment will be presented in listings. Moreover, it will be taken into 
account for the derivation of efficacy endpoints (see section 7.3.3).  
 
9. 
IMMUNOGENICITY, EFFICACY AND PHARMACODYNAMIC ANALYSES 
This study will examine the immunogenicity, efficacy and pharmcodynamics of MOR03087. 
Formal planned analyses are described below. It may be necessary for additional exploratory 
analyses to be completed in this study after results from the planned analysis are completed, to 
assess continued study of MOR03087. Full details of additional analyses will be given in the 
CSR. 
9.1  Immunogenicity Analysis 
One of the primary endpoints is to evaluate the immunogenicity of MOR03087 in the Safety 
Population. Anti-MOR03087 antibodies will be determined by a central laboratory. The analysis 
will be based on both absolute numbers (number and percentage of subjects who develop 
anti-MOR03087 antibodies) and semiquantitative assessments (anti-MOR03087 antibody titer 
determination of confirmed positive samples).  
The number and percentage of subjects who developed confirmed anti-MOR03087 antibodies 
during the study will be summarized descriptively. Rates will be calculated with respect to all 
subjects in the analysis group.  
Exact 95%-confidence intervals will be provided for the rate of subjects who developed anti 
MOR03087 antibodies in combined presentations (see section 7.2). 
Time to development of anti-MOR03087 antibodies [months] will be summarised descriptively 
using Kaplan-Meier estimates for the median, 25% quantile, and 75% quantile. 95%-confidence 
intervals for median, 25% quantile and 75% quantile will be provided in combined presentations. 
Moreover the percentage of subjects having developed antibodies after 2, 4 and 6 months together 
with the corresponding 95%-confidence intervals will be estimated from the Kaplan-Meier curve 
for combined data. 
Kaplan-Meier plots for time to development of anti-MOR03087 antibodies [months] will be 
provided for combined data. 


Protocol: MOR202C101 
 
Page 42 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Exact 95% confidence intervals and Kaplan-Meier analyses will not be produced if only very 
few subjects develop anti MOR03087 antibodies. 
Also, if only a few subjects develop anti MOR03087 antibodies, quantitative assessments will 
only be presented in listings. Otherwise, summary tables may be added. 
 
9.2 Efficacy Analysis 
All efficacy analyses will be provided for the Safety Population and will be repeated for the 
Efficacy Evaluable Population. 
Rates will be calculated for each response category (sCR, CR, VGPR, PR, MR, SD, PD, missing) 
by visit (for C3D1, C6D1, and C12D1). Moreover, the ORR (PR or better), the CBR (MR or 
better) and the DCR (SD or better) will be calculated by visit (see section 7.3.3.1). The 
corresponding number of subjects in each of these response categories and all rates will be 
summarized in a frequency table by visit.  
For best overall response, frequencies will be calculated for each response category (sCR, CR, 
VGPR, PR, MR, SD, PD, NE). Moreover, the ORR (PR or better), CBR (MR or better) and the 
DCR (SD or better) will be calculated, based on BOR per subject (see section 7.3.3.2). The 
corresponding number of subjects in each of these response categories and all rates will be 
summarized in a frequency table. The exact Clopper-Pearson 95%-confidence intervals for ORR, 
CBR and DCR will also be shown in combined presentations. 
The denominator for calculating the rates (rates by visit and best response rates) will be the total 
number of subjects within the corresponding analysis group. In the summary of rates by visit, all 
withdrawals and protocol non-compliances after start of new anti-MM therapy will be analyzed 
as missing for all visits after withdrawal, and the counts of missing observations will be included 
into the denominator. 
Both TTP and PFS will be analyzed using Kaplan-Meier methods. Kaplan-Meier tables for PFS 
and TTP will contain number of subjects, number of subjects with an event (non-censored 
subjects), percentage of subjects with an event, median time [months], 25% and 75% quantile. 
The 95%-confidence intervals for median, 25% quantile and 75% quantile will be provided in 
combined presentations. 
Moreover, the percentage of subjects having an event after 2, 4 and 6 months together with the 
corresponding 95%-confidence intervals will be retrieved from the Kaplan-Meier curve in 
combined presentations. 
For PFS, the reason for censoring as stated in Table 3 will be tabulated together with reasons for 
discontinuation (based on study completion page) for patients who discontinued the study 
without a PFS event. This information will be included in the listings as well together with 
detailed information concerning AE term(s) leading to withdrawal. 
 
In these Kaplan-Meier analyses, the confidence intervals for the median will be calculated 
according to Brookmeyer and Crowley (1982) [12] and confidence intervals for the quartiles 
according to Klein and Moeschberger (1997) [13] who generalized the methods developed by 
Brookmeyer and Crowley. Confidence intervals for the survival function estimates at above 


Protocol: MOR202C101 
 
Page 43 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
defined time points will be derived using the log-log transformation according to Kalbfleisch and 
Prentice (1980) [14] (
). The estimate of 
the standard error will be computed using Greenwood's formula. 
Time to next treatment and EFS will also be analyzed using Kaplan-Meier methods. The same 
type of presentations as for TTP and PFS will be prepared. 
In addition, time to first response, time to best response and time to first clinical benefit will be 
analyzed using Kaplan-Meier methods restricted to the subgroups of responders without having 
any censored subjects. The same type of presentations as for TTP and PFS will be prepared. 
Duration of response and further duration variables defined in section 7.3.3.3 will also be 
analyzed using Kaplan-Meier estimates for median, 25% and 75% quantile, but this analysis will 
be restricted to the subgroup of subjects with response or in general, the subgroup of subjects 
where the duration can be calculated 
Kaplan-Meier plots for all time-to-event variables will be provided for combined data. 
9.2.1 Subgroup Analysis 
For BOR, ORR, CBR, DCR and PFS, subgroup analyses will be performed within the subgroups 
defined in section 7.4. The data will be presented in the same format as described above, within 
those subgroups of the safety population. The subgroup analysis will only be performed for 
combined presentations. 
9.3 Pharmacodynamic Analysis 
All pharmacodynamic analyses, except of serum and urine M-protein, and serum FLCs, will be 
performed for the safety population only. 
MorphoSys AG will perform further post hoc exploratory analysis to investigate correlations 
between different biomarkers and response variables, which are not further described in this SAP. 
In general, pharmacodynamic analyses by visit will only include all cycles until Cycle 6, 
Cycle 12 and EOS. 
9.3.1 Pharmacodynamic Parameters Measured in Blood or Urine 
Actual values and absolute and percent changes from baseline will be summarised descriptively 
by visit for the pharmacodynamic parameters specified below. Moreover, 95%-confidence 
intervals will be provided for mean and median changes in summaries of absolute changes from 
baseline and for median changes in summaries of percentage changes from baseline in all 
combined presentations. 
Measurements of B, T, and NK cell populations and CD16 expression on NK cells: Descriptive 
summaries (as specified above) will be provided for the following parameters: 
• Measurements of B, T, and NK cells [%] 
Measurements of B, T, and NK cells [/µl] 
Measurements of B, T, NK cells are given in % and/or as absolute count [/µl] by the 
investigator, whereas the absolute count is often missing. Therefore absolute count [/µl] 
will be also be derived using the lymphocytes absolute values [G/l = n*1000/µl = /nl] 
from the laboratory hematology data (lymphocytes absolute * [measurement in % /100] 


Protocol: MOR202C101 
 
Page 44 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
* 1000, rounded without decimals). Two tables each will be presented, one table based 
on % values (original values only) and a further table based on absolute counts [/µl] 
(derived and original values, both rounded wihout decimals).  
• CD16 expression on NK cells [Antibodies bound per cell] 
The analysis will be based on the unit “antibodies bound per cell”. Measurements cannot 
be included in the analysis if measurements in the unit “antibodies bound per cell” are 
missing. 
Result of Flow Cytometry of Peripheral MM Cells: Descriptive summaries will be provided for 
the following parameters: 
• Measurements of CD138 cells [Count per 106 cells] 
• Percentage of malignant CD38 cells [%] 
• Measurement of CD38 expression on malignant cells in [MFI] (MFI = Median 
Fluorescence Intensity) 
• Measurement of CD38 expression on malignant cells in [Antibodies bound per cell] 
In the summaries of actual values for CD38 variables, only subjects who have counts of CD138+ 
cells equal and above 100 counts per 106 cells at the corresponding visit will be included since 
for subjects who have counts of CD138+ cells below 100 counts per 106 cells no values for CD38 
variables will be available. In the summary of absolute and percentage changes from baseline for 
CD38 variables, only subjects who have counts of CD138+ cells above 100 counts per 106 cells 
at both baseline and post-baseline visits will be included. 
Serum and Urine M-Protein, Serum FLCs: Serum and urine M-protein and serum FLCs were 
analyzed by a local laboratory at the beginning of the study and by central laboratory enrolled 
after November 2014 (starting from cohort 7c/ cohort 8 partially, see section 7.3.4 for parameters 
measured and derived). Descriptive summaries by visit (including summaries of absolute and 
percentage changes) will be provided for the following parameters by visit:  
• Serum M-protein level [g/L] 
• Urine M-protein result [g/24h] 
• Lambda FLCs [mg/L] 
• Kappa FLCs [mg/L] 
• Kappa/lambda FLC ratio  
Moreover, descriptive summaries across time points will be prepared for  
• relative change (%) in serum M-protein result from baseline to post-baseline nadir  
• relative change (%) in urine M-protein result from baseline to post-baseline nadir. 
Anti-TT data (Anti-Tetanus Toxoid IgG data): Anti-TT data will only be presented in listings. 
9.3.2 Pharmacodynamic Parameters Measured in Bone Marrow 
A bone marrow examination will be performed at screening (results from bone marrow 
examination done within 4 weeks prior to screening are also acceptable, if the subject has been 
hematologically stable since then). Post-baseline bone marrow data will only be assessed for 


Protocol: MOR202C101 
 
Page 45 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
subjects who provided an additional informed consent at follow-up visit, or at the Cycle 2 Day 1 
visit for subjects enrolled after Nov 2014 (starting from cohort 7c/ cohort 8 partially). Descriptive 
summaries will be provided for baseline and post-baseline values of the parameters specified 
below. Summaries for absolute and percentage changes are not planned to be provided, because 
of the expected low number of subjects who have bone marrow data after start of treatment. 
However, these may be added if a sufficient number of subjects with post-baseline bone marrow 
data will be available. 
Bone Marrow Histology: Descriptive summaries of actual values will be provided for the 
following parameters: 
• % of plasma cells 
• Myeloid to erythroid ratio  
o The myeloid to erythroid ratio will be given in the format “xx:xx”. For 
descriptive summary tables the quotient will be calculated.  
All other parameters (Cellularity, histology of plasma cells, histology of erythroid cells, histology 
of myeloid cells and histology of megacaryocytes) will only be included in listings since these 
are captured as free text. 
Immunophenotyping of MM cells (bone marrow): Descriptive summaries of actual values will 
be provided for the following parameters: 
• 
Measurements of CD138 cells [% of all bone marrow cells] 
• 
Measurements of CD38 cells 
• 
Percentage of malignant CD38 cells [%] 
• 
Measurement of CD38 expression on malignant cells in [HIT2 MFI]  
• 
Measurement of CD38 expression on malignant cells in [QuantiBrite™ 
MFI]  
• 
Measurement of CD38 expression on malignant cells in [HIT2 Antibodies 
bound per cell] 
• 
Measurement of CD38 expression on malignant cells in [QuantiBrite™ 
Antibodies bound per cell] 
9.4 Pharmacokinetic Analysis 
The pharmacokinetic analysis will be described in a separate pharmcokinetic analysis plan. 
9.5  Other Parameters 
In general, other analyses by visit will only include all cycles until Cycle 6, Cycle 12 and EOS.  
9.5.1 Cytokines 
Cytokines will be measured at Day 1, Cycle 1 before study drug administration and 2 hours after 
end of study drug administration. Actual values and absolute and percent changes from 
pre-administration to post-administration will be summarised descriptively. Moreover, 
95% confidence intervals will be provided for mean and median changes in summaries of 


Protocol: MOR202C101 
 
Page 46 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
absolute changes from baseline and for median changes in summaries of percentage changes 
from baseline in combined presentations. 
9.5.2 Bone / Skeletal Survey 
Bone/skeletal survey by x-ray, computer tomography or magnetic resonance imaging will only 
be performed at screening and EOS where medically indicated as a regular assessment of 
standard care. Thus, the data of bone/skeletal surveys will only be listed. 
9.5.3 Quality of Life 
Standardized scores for quality of life for all categories (scales) will be calculated as described 
in section 7.3.5. The standardized scores and the absolute changes from baseline will be 
summarized descriptively by visit. Moreover, 95%-confidence intervals will be provided for 
mean and median changes in summaries of absolute change from baseline for combined data. 
 
10. SAFETY AND TOLERABILITY ANALYSES 
The analysis of safety assessments in this study will include summaries of the following 
categories of safety data collected for each subject: 
• Adverse Events (AEs), i.e. pre-treatment AEs, treatment emergent AEs (TEAEs), 
and Serious AEs (SAEs) 
• AEs leading to discontinuation 
• Any deaths 
• Dose-limiting toxicities 
• Infusion reactions  
• Clinical laboratory investigations (hematology, serum chemistry, coagulation, 
endocrinology, urinalysis) 
• Vital signs (blood pressure, heart rate, respiratory rate, body temperature) 
• Electrocardiogram (ECG) results   
• Physical examination results 
• Exposure to study drug 
• Discontinued subjects 
10.1 Dose Limiting Toxicities and Maximum Tolerated Dose 
One of the primary endpoints will be to determine the MTD or recommended dose and dosing 
regimen for MOR03087 with or without DEX and in combination with 2 standard IMiD 
therapies, Lenalidomide and Pomalidomide. This primary endpoint will be determined in the 
DLT Evaluable Population and will be based on a 4-week safety assessment period (one 28-day 
cycle). 
Following completion of Parts A-C (dose escalation of MOR03087 alone and in combination 
with DEX using 2 dosing schedules), the MTD and/or recommended dose will be confirmed in 
a minimum of 6 subjects. Following completion of Parts D and E (dose escalation of MOR03087 


Protocol: MOR202C101 
 
Page 47 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
in combination with POM + DEX and in combination with LEN + DEX), the MTD and/or 
recommended dose in each treatment arm will be confirmed in a minimum of 6 subjects. 
The recommended doses for the confirmation cohorts will be determined after review of all 
available safety data from the corresponding dose escalation portion of the study and based on 
the recommendation of the DMC. The recommended dose may be the MTD or a dose below the 
MTD.  
The MTD is defined as the dose level below the dose level at which 2 out of 3 subjects or 2 out 
of 6 subjects experience a DLT, as described in the dose-escalation plan (see section 3.1).  
All DLTs will be entered as AEs on the Adverse Event Page and identified by the investigator as 
DLTs by ticking the corresponding field (dose limiting toxicity yes/no). Moreover, there is an 
additional field on the AE page (hidden for site entry) which contains the information regarding 
whether the AE is a DLT according to the decision of the sponsor assessment or DMC as 
documented in the meeting minutes. The additional DLT field will not need to be filled out in 
case of unambiguous cases. 
Thus, the analysis of DLTs will be described within the subsequent sections covering the analysis 
of AEs. For DLT analyses, DLTs will be filtered based on the following approach. If the field 
“DLT as per sponsor assessment or DMC decision” is filled out, this field will be used to 
determine if AE is a DLT, otherwise the field “Is this Adverse Event a Dose-Limiting Toxicity?”, 
which is filled out by the Investigator, will be used. 
The DLT summaries will only be presented for the first cycle, as the DLT period covers Day 1 
of Cycle 1 (starting with first study drug administration) until Day 29 (before start of the second 
cycle). DLTs occurring in subjects from the confirmation cohorts will be included. 


Protocol: MOR202C101 
 
Page 48 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
10.2 
Adverse Events 
All TEAEs and SAEs will be coded using MedDRA (MedDRA Version 20.1, and updated to the 
newest version 23.0 for the follow-up analyses).  
The body systems 'Blood and lymphatic system disorders' and 'Investigations' will be combined 
for the purpose of analysis. Moreover, all preferred terms from those two body systems that are 
subsequently listed in the same row will be combined: 
• Red blood cell count decreased / Haemoglobin decreased / Haematocrit decreased / Mean 
cell volume decreased / Anaemia 
• Fibrin D dimer increased / International normalised ratio increased / Prothrombin time 
shortened / Coagulopathy 
• Eosinophil count increased / Eosinophilia 
• Blood fibrinogen increased / Hyperfibrinogenaemia  
• White blood cell count increased / Leukocytosis  
• White blood cell count decreased / Leukopenia 
• Lymphocyte count decreased / Natural killer cell count decreased / CD4 lymphocytes 
decreased / B-lymphocyte count decreased / Lymphopenia 
• Monocyte count decreased / Monocytopenia 
• Neutrophil count decreased / Neutropenia 
• Neutrophil count increased / Neutrophilia 
• Plasma cells increased / Plasmacytosis 
• Platelet count decreased / Thrombocytopenia  
TEAEs are defined as AEs occurring or worsening after the start (date and time) of the first study 
treatment (any IMP) and up to 28 days after the last study treatment including all treatment cycles 
(treatment emergent period). However, AEs occurring or worsening later than 28 days after the 
last treatment with study drug are defined as treatment emergent if these are considered to be 
related to the study drug. 
If the start date and time of an AE are partially or completely missing, the AE will be assumed 
to be treatment-emergent if it cannot be definitely shown that the AE did not occur or worsen 
during the treatment-emergent period (worst case approach). Missing dates and times will not be 
replaced.  
Thus, the following approach will be taken: 
• If the start time of an AE is missing but the start date is complete, an AE will only be 
excluded from TEAEs if the start day is before the day of first treatment or the start day 
is after the end day of the treatment-emergent period. 
• If the start time and day are missing but the start month is complete, an AE will only be 
excluded from TEAEs if the start month is before the month of first treatment or the start 


Protocol: MOR202C101 
 
Page 49 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
month is after the end month of the treatment-emergent period or if stop date/time is 
before start of first treatment. 
• If the start day and months are missing but the start year is complete, an AE will only be 
excluded from TEAEs if the start year is before the year of first treatment or if the start 
year is after the end year of the treatment-emergent period or if the stop date/time is before 
the start of first treatment. 
• If the start date is completely missing, an AE will not be excluded from TEAEs unless 
the stop date/time is before the start of first treatment. 
Time from first treatment to onset of AE [days] will be calculated for complete dates only and 
will be included in listings. 
The TEAE grading will be determined by the investigators according to the NCI-CTC toxicity 
criteria. If a subject experiences a specific type of adverse event more than once, only the 
maximum grading will be considered in tables of TEAEs by grading when calculating the 
incidences (number and percentage of subjects with AE of specific type and grade).  
One of the primary endpoints will be to determine the incidence and severity of AEs.  
A TEAE summary table will be presented showing the incidence and frequency of all 
• Treatment-emergent AEs (TEAEs) 
• TEAEs by grading (according to NCI-CTCAE toxicity criteria) 
• TEAEs with Grade ≥ 3  
• TEAEs with Grade 1 and 2 
• TEAEs with Grade 3 and 4  
• TEAEs related to MOR03087 / Pomalidomide / Lenalidomide / Dexamethasone 
• Serious adverse events (SAEs) 
• Serious adverse events (SAEs) related to MOR03087 / Pomalidomide / Lenalidomide / 
Dexamethasone 
• MOR03087-related TEAEs by grading (according to NCI-CTCAE toxicity criteria) 
• Pomalidomide-related TEAEs by grading (according to NCI-CTCAE toxicity criteria) 
• Lenalidomide-related TEAEs by grading (according to NCI-CTCAE toxicity criteria) 
• Dexamethasone-related TEAEs by grading (according to NCI-CTCAE toxicity criteria) 
• DLTs  
• Infusion reactions 
• TEAEs leading to any action on MOR03087 / Pomalidomide / Lenalidomide / 
Dexamethasone 
• TEAEs leading to withdrawal of MOR03087 / Pomalidomide / Lenalidomide / 
Dexamethasone 


Protocol: MOR202C101 
 
Page 50 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
• TEAEs that caused the subject to withdraw from the study 
• Symptomatic overdoses reported as TEAE 
The incidence refers to the number and percentage of subjects with at least 1 TEAE of the 
specified type and the frequency to the number and percentage of AEs.  
Exact 95%-confidence intervals for the incidence rates will be included in the summary tables 
for the combined data. 
The analyses by grading will be based on the NCI-CTCAE grade (version 4.0). If the 
NCI-CTCAE grade is not available, this will be analyzed as “Missing”.  
A further summary table of the same structure will be presented which includes only AEs with a 
start date in the first cycle (relevant for the determination of the MTD and recommended dose). 
In case of incomplete start dates, an AE will be allocated to the first cycle, if it cannot be excluded 
that the AE started within the first cycle based on the month or year of the incomplete start date. 
Summaries of incidence rates (number and percentage of subjects) and frequencies (number and 
percentage of AEs) of individual TEAEs by MedDRA SOC and Preferred Term will be prepared. 
Such summaries will be displayed for all AEs in fhe following categories: 
• TEAEs  
• TEAEs related to MOR03087 
• TEAEs related to DEX 
• TEAEs related to LEN 
• TEAEs related to POM 
• TEAEs by maximum grading according NCI-CTCAE  
• DLTs 
• Infusion reactions 
• TEAEs leading to withdrawal of any study drug 
• TEAEs that caused the subject to withdraw from the study 
• TEAEs of Grade ≥ 3 
• TEAEs with Grade 1 and 2  
• TEAEs with Grade 3 and 4  
• SAEs 
• SAEs related to any treatment 
• SAEs leading to death 
• SAEs leading to death related to any treatment 
• Non-serious TEAEs 


Protocol: MOR202C101 
 
Page 51 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
In these summaries each subject will be counted only once within each preferred term to calculate 
the incidences.   
The summaries of all TEAEs (summary table + TEAEs by grading) will be repeated including 
only TEAEs from the first cycle. The DLT summary will only be presented for the first cycle. 
The time to the first TEAE will be summarized by summary statistics (n (number of subjects with 
event), mean, standard deviation, median, Q1, Q3, min, max) for the following TEAEs: 
• Each AESI (infusion reactions >= grade 3, cytokine release >= grade 3, allergic reaction 
to MOR03087 >= grade 3, second primary malignancies (all grades) and DLTs (all 
grades) 
• All PTs >= grade 3 in SOC Infections, and per PT in SOC infections with >= grade 3 
• Hematological AEs per PT >= grade 3 (i.e. all PTs >= grade 3 in SOC Blood and 
lymphatic system disorder including the ones combined with SOC Investigations as 
described above, and per PT in SOC Blood and lympathatic system disorder including 
the ones combined with SOC Investigations as described above with >= grade 3) 
• Diarrhoea >= grade 3 
Only patients experiencing a TEAE as mentioned above will be included in the summary table. 
The same table will be repeated for TEAEs related to MOR03087. 
 
Exposure-adjusted incidence rate (EAIR) will be expressed as the number of patients 
experiencing an AE per patient-year (PY) of exposure to treatment and is derived as the number 
of patients with the event divided by the sum of all patient time at risk. Time at risk is the number 
of years from first treatment date to first event for patients experiencing a given event, or time 
on treatment in years (up to 28 days after the last study treatment) for patients who did not 
experience the event.  
EAIR will be summarized by SOC and PT for the following:  
• All TEAEs 
• TEAEs related to MOR03087 
• TEAEs related to any study drug 
• TEAEs by grading according to NCI-CTCAE 
• TEAEs leading to withdrawal of any study drug 
• TEAEs that caused the subject to withdraw from the study 
• SAEs 


Protocol: MOR202C101 
 
Page 52 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
In the AE listings, AEs that started prior to the administration of any study drug will be flagged 
as pre-treatment AEs. Any AEs that start 28 days after the last study treatment, including all 
treatment cycles, will be flagged as post-treatment AEs. 
A special AE summary listing displaying details of the event(s) captured on the eCRF in a 
compact format will be provided for  
• DLTs 
• Infusion reactions 
• AEs leading to discontinuation on MOR03087 
• AEs leading to discontinuation on Pomalidomide / Lenalidomide 
• SAEs 
Serious adverse event reconciliation will be performed by Data Management, Clinical Research, 
and Premier Research Drug Safety and Pharmacovigilance via data listings, as detailed in the 
SAE reconciliation plan. 
The sponsor will describe other AEs of special interest (i.e. infusion reactions, cytokine release, 
allergic reaction to MOR03087, second primary malignancies and DLTs), in addition to those 
reported as SAEs. 
10.3 Clinical Laboratory Evaluations 
Safety laboratory data (hematology, serum chemistry, endocrinology, coagulation, urinalysis) 
will be analyzed by the respective local laboratories of each involved site. 
The analysis of safety laboratory parameters will be presented separated into blood parameters 
(hematology, serum chemistry, endocrinology, coagulation) and urine parameters (urinalysis). 
All data will be listed. 
The blood parameters will be transformed to SI values based on SI units to make laboratory 
parameters comparable between different local laboratories. The relevant reference ranges 
supplied by each laboratory will also be transformed to SI reference ranges for each laboratory. 
Descriptive summaries of actual (absolute) values and changes from baseline values will be 
presented for all blood parameters. 
Creatinine clearance will be calculated according to the Cockcroft-Gault formula and will be 
included in descriptive summaries of actual (absolute) values and changes from baseline. 
Each abnormal value will be flagged to show whether it is a value below or above the reference 
range. For the assessment of laboratory variables, 5 categories will be used that take into account 


Protocol: MOR202C101 
 
Page 53 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
the investigator’s assessment of clinical relevance: ‘clinically relevant, above’, ‘non-clinically 
relevant, above’, ‘within’, ‘non-clinically relevant, below’, ‘clinically relevant, below’. 
The assessment of laboratory variables will be tabulated by time point for each clinical laboratory 
analyte (frequency tables).  
If NCI-CTCAE grades are available for a clinical laboratory analyte, these will be derived 
according to NCI-CTCAE version 4.0 and used to present additional frequency based on NCI-
CTCAE grades. 
For hematology parameters, shifts in assessments from baseline to worst-post baseline will be 
presented based on classifications relative to the laboratory reference ranges (low/normal/high) 
for hematology parameters where NCI-CTCAE grades are not defined. If a subject experiences 
both “Low” and “High” assessments in the course of the trial, the worst post-baseline will be 
defined as “Low and High”.  
 
If NCI-CTCAE grades are available for a hematology parameter, frequency, shift and summary 
tables based on grades will be created as follows: 
• Incidence of subjects with worst post-baseline grade. Each subject will be counted only 
for the worst grade 
• Shift tables to compare baseline to the worst post-baseline value using CTCAE grades  
• Summary of time to onset toworst post-baseline grade (defined as the time from treatment 
start to first occurrence of worst post-baseline grade): this table will present summary 
statistics over all grades, but only patients with a worst post-baseline grade will be 
included. 
A separate listing will be prepared to list the time course of a laboratory parameter for a subject 
with any abnormal, clinically significant laboratory value (for all laboratory values irrespectively 
of whether NCI-CTCAE grades are available).  
The investigator’s assessment of categorical urinalysis variables (‘normal’, ‘abnormal, not 
clinically significant’, ‘abnormal clinically significant’) will be tabulated by time point for each 
urine parameter (frequency tables).  
Additionally, for each of these urine parameters, shifts in assessments from baseline to Cycle 2 
Day 1 and to EOS will be presented for combined data. 
For all shift tables, baseline percentage will be based on the number of patients in the analysis 
set (N). Percentage for worst post-baseline value will be based on Baseline n for the baseline 
category the percentage refers to. 
Laboratory values that are outside the reference range will also be flagged in the data listings, 
along with corresponding reference ranges. 


Protocol: MOR202C101 
 
Page 54 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Results of unscheduled laboratory evaluations, laboratory data of the emergency laboratory, 
results of urine microscopy (if available), results of the pregnancy test and screening serology 
results will only be included in listings. 
In general, laboratory summaries except for the tables analyzing the hematology parameters 
(worst post-baseline assessments/grades) as described above will only include time points of 
Cycle 1+2 and EOS visit. For the tables analysing the hematological parameters, all available 
time points will be included when deriving worst assessment/worst grade. 
10.4 Vital Signs and Body Weight 
Descriptive summaries of actual values and changes from baseline will be calculated for vital 
signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], body temperature, heart 
rate [HR], and respiratory rate [RR]) and body weight and BMI. These summaries will be 
presented for all time points.  
Each abnormal value will be flagged to show whether it is a value below or above the normal 
limit. The normal limits are detailed in the appendix of the study protocol (section 18.2 of the 
study protocol). 
In general, vital signs summaries will only include time points of Cycle 1+2 and EOS visit. 
10.5 Electrocardiograms 
The summary ECG assessment (categories: <normal; abnormal clinically significant; abnormal 
not clinically significant>) will be tabulated by visit. 
Each abnormal PR, QRS, and RR interval value will be flagged to show whether it is a value 
below or above the normal limit. The normal limits are detailed in the appendix of the study 
protocol (section 18.2 of the study protocol). 
Descriptive summaries of actual values and changes from baseline will be presented by visit for 
ECG measures of RR interval, PR interval, QRS interval, QT interval, QTc interval (both 
correction methods), and HR (Heart rate).  
The Bazett’s Correction (QTcb) and Fridericia’s Correction (QTcf) for the QTc interval will be 
derived as follows: 
Bazett’s Correction (QTcb) 
RR
QT
QTc
m
b
sec
=
 
Fridericia’s Correction (QTcf) 
3
sec
RR
QT
QTc
m
f =
 
where: RR = Relative Rate = 60 / HR  
  
HR = Heart Rate obtained from the ECG. 


Protocol: MOR202C101 
 
Page 55 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
Also, the number and percent of subjects with QTc values (Bazett’s correction) above the normal 
limit (441-480 ms, 481-500 ms, or > 500 ms) and the number and percent of subjects who 
experienced a change > 30 ms or a change > 60 ms from baseline will be presented by visit. 
Moreover, shifts in QTc category (Bazett’s correction) from baseline to all post-baseline visits 
will be presented for combined data, based on the following categories (normal, 441-480 ms, 
481-500 ms, or > 500 ms).  
QTcF interval will only be presented in listings (along with the QTcB interval). 
In general, ECG summaries will only include time points of Cycle 1+2 and EOS visit. 
10.6 Physical Examination 
The physical examination assessments (normal, abnormal not clinically significant, abnormal 
clinically significant) will be summarized by body system and visit. 
Separate listings will be prepared to list the time course for the assessments of a specific body 
system for a subject with any abnormal, clinically significant result. 
In general, physical examination summaries will only include time points of Cycle 1+2 and EOS 
visit. 
10.7 Measurement of Exposure 
Variables that will be calculated to measure exposure to study drugs (MOR03087, POM, LEN, 
DEX) are described in section 7.3.6. All variables calculated on a per-subject basis for all cycles 
will be summarized descriptively.  
Summaries for POM, LEN and DEX will be presented for the respective combination cohorts 
only. 
10.8 Karnofsky Performance Status 
The Karnofsky performance status [%] will usually be given in steps of 10% each, e.g. possible 
values are 100%, 90%, 80%, …, 10%, 0% (if in between values are given, values will be rounded 
in accordance with typical mathematical principles). The Karnofsky performance status [%] will 
be summarized categorically in a frequency table by visit. A further table showing summary 
statistics will be presented.  
 


Protocol: MOR202C101 
 
Page 56 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
11. REPORTING CONVENTIONS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
  
 


Protocol: MOR202C101 
 
Page 57 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 58 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
12. REFERENCES 
1. US Federal Register. (1998) International Conference on Harmonization; Guidance 
on Statistical Principles for Clinical Trials. Department of Health and Human 
Services: Food and Drug Administration [Docket No. 97D-0174]. Federal Register 
Volume 63, Number 179, pages 49583-49598. September 16, 1998. 
2. American Statistical Association. (1999) Ethical Guidelines for Statistical Practice. 
Prepared by the Committee on Professional Ethics, August 7, 1999.  
3. Royal Statistical Society (1993) The Royal Statistical Society: Code of Conduct, 
August 1993. 
4. Lonial S. Relapsed multiple myeloma. Hematology Am Soc Hematol Educ 
Program. 2010;2010:303–309. 
5. Chng, W J; Dispenzieri, A; Chim, C-S; et al. IMWG consensus on risk stratification 
in multiple myeloma. (International Myeloma Working Group). Leukemia. 2014; 
28(2):269-77. 
6. Durie BGM, Harousseau J-L, Miguel JS, et al on behalf of the International 
Myeloma Working Group. International uniform response criteria for multiple 
myeloma. 
Leukemia. 
2006;20(9):1467-1473. 
Erratum 
in: 
Leukemia. 
2007;21(5):1134 and 2006;20(12):2220.  
7. Blade J, Samson D, Reece D, et al. Criteria for evaluating disease response and 
progression in patients with multiple myeloma treated by high-dose therapy and 
haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. 
European Group for Blood and Marrow Transplant. Br J Haematol. 
1998;102(5):1115-1123. 
8. Sprangers MA, Cull A, Groenvold M, Bjordal K, Blazeby J, Aaronson NK. The 
European Organization for Research and Treatment of Cancer approach to 
developing questionnaire modules: an update and overview. EORTC Quality of 
Life Study Group. Qual Life Res. 1998;7(4):291-300. 
9. Stead ML, Brown JM, Velikova G, et al. Development of an EORTC questionnaire 
module to be used in health-related quality-of-life assessment for patients with 
multiple myeloma. European Organization for Research and Treatment of Cancer 
Study Group on Quality of Life. Br J Haematol. 1999;104(3):605-611. 
10. Cocks K, Cohen D, Wisløff F, et al; EORTC Quality of Life Group. An 
international field study of the reliability and validity of a disease-specific 
questionnaire module (the QLQ-MY20) in assessing the quality of life of patients 
with multiple myeloma. Eur J Cancer. 2007;43(11):1670-1678. 
11. Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on 
behalf of the EORTC Quality of Life Group. EORTC QLQ-C30 Scoring Manual 
(3rd edition). Published by: European Organisation for Research and Treatment of 
Cancer. Brussels 2001. 
12. Brookmeyer R, Crowley J. A Confidence Interval for the Median Survival Time. 
Biometrics. 1982;38(1):29-41. 
13. Klein JP, Moeschberger ML. Survival Analysis: Techniques for Censored and 
Truncated Data, New York: Springer-Verlag; 1997.  
14. Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. New York: 
Wiley; 1980. 


Protocol: MOR202C101 
 
Page 59 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 60 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 61 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 


Protocol: MOR202C101 
 
Page 62 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 63 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 


Protocol: MOR202C101 
 
Page 64 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 65 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 66 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
  
 
 


Protocol: MOR202C101 
 
Page 67 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 68 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 69 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 


Protocol: MOR202C101 
 
Page 70 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 


Protocol: MOR202C101 
 
Page 71 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 


Protocol: MOR202C101 
 
Page 72 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 73 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 74 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
  
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 75 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 76 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 77 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: MOR202C101 
 
Page 78 of 78 
Statistical Analysis Plan FINAL Version 3.0 
 
 
CONFIDENTIAL 
 
28SEP2020