Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma
Phase: PHASE4
Conditions: Plasma Cell Myeloma
Sponsor: Thomas Jefferson University

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THOMAS JEFFERSON UNIVERSITY 
Sidney Kimmel Cancer Center 
 
 
Open Label Single Arm Study to Assess the Implementation of Home Based 
Daratumumab Administration In Patients Being Treated for Multiple 
Myeloma 
 
Principal Investigator: 
Adam Binder 
Department of Medical Oncology 
925 Chestnut, 4th Floor 
Philadelphia, PA 19107 
215-955-8874 
Co-Investigator(s): 
Ubaldo Outschoorn-Martinez 
Department of Medical Oncology 
925 Chestnut, 4th Floor 
Philadelphia, PA 19107 
215-955-8874 
Andres Ferber 
Department of Medical Oncology 
925 Chestnut, 4th Floor 
Philadelphia, PA 19107 
215-955-8874 
Gina Keiffer 
Department of Medical Oncology 
925 Chestnut, 4th Floor 
Philadelphia, PA 19107 
215-955-8874 
Joanne Filicko-Ohara 
Department of Medical Oncology 
925 Chestnut, 4th Floor 
Philadelphia, PA 19107 
215-955-8874 
Pierluigi Porcu, MD 
Department of Medical Oncology 
834 Chestnut Street, Suite 320 
Philadelphia, PA19107 
215-955-8874 
Margaret Kasner, MD MSCE 
Department of Medical Oncology 
834 Chestnut Street, Suite 320 
Philadelphia, PA19107 
215-955-8874 
Lindsay Wilde, MD 
Department of Medical Oncology 
834 Chestnut Street, Suite 315 
Philadelphia, PA19107 

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215-955-8874 
S. Onder Alpdogan, MD 
Department of Medical Oncology 
834 Chestnut Street, Suite 308 
Philadelphia, PA19107 
215-955-8874 
Joanne Filicko-O’Hara, MD 
Department of Medical Oncology 
834 Chestnut Street, Suite 308 
Philadelphia, PA19107 
215-955-8874 
Statistician: 
Inna Chervoneva 
Division of Biostatistics 
Department of Pharmacology and Experimental Therapeutics 
1015 Chestnut Street Building 
Funding Company: 
Janssen Scientific Affairs, LLC 
1125 Trenton-Harbourton Road, 
Titusville, New Jersey 08560 
IND/IDE Holder: 
N/A 
IND/IDE Number: 
N/A 
Study Product: 
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) 
Protocol IDs: 
JeffTrial # 19521 
PRC # 2022-011 
IRB Control # 22C.210 

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Version Number: 
Version Date: 
1.1 
03/02/2021 
1.2 
05/10/2021 
1.3 
07/08/2021 
1.4 
11/22/2021 
1.5 
02/15/2022 
1.6 
03/10/2022 
2.0 
06/13/2022 
2.1 
07/13/2022 
3.0 
08/13/2022 
3.1 
11/17/2022 
4.0 
04/18/2023 
5.0 
07/26/2023 
6.0 
03Jan2024 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of THOMAS JEFFERSON UNIVERSITY. 
No part of it may be transmitted, reproduced, published, or used by other persons 
without prior written authorization from the study sponsor. 

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Table of Contents 
Signature Page ............................................................................................................................ 10 
Statement of Compliance ............................................................................................................ 10 
List of Abbreviations .................................................................................................................... 11 
Study Summary ........................................................................................................................... 13 
1 
Introduction ........................................................................................................................... 15 
1.1 
Background Information ................................................................................................ 15 
1.2 
Rationale for the Proposed Study ................................................................................. 16 
1.3 
Correlative Studies ........................................................................................................ 17 
1.4 
Potential Risks and Benefits ......................................................................................... 17 
1.4.1 Potential Risks ........................................................................................................... 17 
1.4.2 Benefits ..................................................................................................................... 17 
2 
Study Objectives ................................................................................................................... 17 
2.1 
Objectives ..................................................................................................................... 17 
2.1.1 Primary ...................................................................................................................... 17 
2.1.2 Secondary ................................................................................................................. 17 
2.1.3 Exploratory ................................................................................................................ 18 
2.2 
Endpoints/Outcome Measures ...................................................................................... 18 
2.2.1 Primary ...................................................................................................................... 18 
2.2.2 Secondary ................................................................................................................. 18 
2.2.3 Exploratory ................................................................................................................ 18 
3 
Study Design ........................................................................................................................ 18 
3.1 
Characteristics .............................................................................................................. 18 
3.2 
Number of Participants .................................................................................................. 18 
3.3 
Duration of Therapy ...................................................................................................... 19 
3.4 
Duration of Follow Up .................................................................................................... 19 

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3.5 
Treatment Assignment Procedures ............................................................................... 19 
3.5.1 Randomization Procedures (if applicable) ................................................................. 19 
3.5.2 Masking Procedures (if applicable) ............................................................................ 19 
3.6 
Study Timeline .............................................................................................................. 19 
3.6.1 Primary Completion ................................................................................................... 19 
3.6.2 Study Completion ...................................................................................................... 19 
4 
Study Enrollment and Withdrawal ......................................................................................... 19 
4.1 
Eligibility Criteria............................................................................................................ 19 
4.1.1 Inclusion Criteria ........................................................................................................ 19 
4.1.2 Exclusion Criteria....................................................................................................... 20 
4.2 
Gender/Minority/Pediatric Inclusion for Research ......................................................... 21 
4.3 
Strategies for Recruitment and Retention ..................................................................... 21 
4.4 
Participant Withdrawal .................................................................................................. 22 
4.4.1 Reasons for Withdrawal ............................................................................................ 22 
4.4.2 Handling of Participant Withdrawals and Participant Discontinuation of Study 
Intervention ........................................................................................................................... 22 
4.5 
Premature Termination or Suspension of Study ............................................................ 23 
5 
Study Intervention ................................................................................................................. 23 
5.1 
Study Product ............................................................................................................... 23 
5.1.1 Daratumumab SC Dosing: ......................................................................................... 23 
5.2 
Study Product Description ............................................................................................. 24 
5.2.1 Acquisition ................................................................................................................. 24 
5.2.2 Formulation, Packaging, and Labeling ...................................................................... 24 
5.2.3 Product Storage and Stability .................................................................................... 24 
5.3 
Dosage, Preparation, and Administration ...................................................................... 24 
5.4 
Dose Modifications and Dosing Delays ......................................................................... 25 
5.5 
Study Product Accountability ......................................................................................... 25 

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5.6 
Assessing Participant Compliance with Study Product Administration .......................... 25 
5.7 
Concomitant Medications/Treatments ........................................................................... 25 
5.7.1 Pre-dose Medications for Prevention of Injection Reactions ...................................... 25 
5.7.2 Post-dose Medication: ............................................................................................... 26 
5.7.3 Prophylaxis for Herpes Zoster ................................................................................... 27 
5.7.4 Prophylaxis and Management of Hepatitis B Reactivation ........................................ 27 
5.8 
Dietary Restrictions ....................................................................................................... 28 
None ........................................................................................................................................ 28 
6 
Study Schedule ..................................................................................................................... 28 
6.1 
Pretreatment Period/Screening ..................................................................................... 28 
6.2 
Treatment Period .......................................................................................................... 28 
6.3 
End of Treatment Study Procedures ............................................................................. 33 
6.4 
Post-treatment/Follow-Up .............................................................................................. 34 
6.5 
Long Term/Survival Follow-up ....................................................................................... 34 
7 
Study Procedures and Evaluations ....................................................................................... 34 
7.1 
Study Procedures/Evaluations ...................................................................................... 34 
7.2 
Laboratory Procedures/Evaluations .............................................................................. 34 
7.2.1 Clinical Laboratory Evaluations ................................................................................. 34 
7.2.2 Special Assays or Procedures ................................................................................... 35 
7.2.3 Specimen Preparation, Handling, and Storage .......................................................... 35 
7.2.4 Specimen Shipment .................................................................................................. 35 
8 
Evaluation of Safety .............................................................................................................. 35 
8.1 
Specification of Safety Parameters ............................................................................... 35 
8.1.1 Product Quality Complaints ....................................................................................... 35 
8.1.2 Unanticipated Problems ............................................................................................ 36 
8.1.3 Adverse Events ......................................................................................................... 36 

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8.1.4 Adverse Events of Special Interest ............................................................................ 36 
8.1.5 Serious Adverse Events ............................................................................................ 37 
8.1.6 Hospitalizations ......................................................................................................... 38 
8.1.7 Life-threatening Conditions ........................................................................................ 38 
8.1.8 Special Situations ...................................................................................................... 38 
8.2 
“Extraordinary” correspondence .................................................................................... 39 
8.3 
Safety Assessment and Follow-Up ............................................................................... 39 
8.4 
Recording Adverse Events ............................................................................................ 39 
8.4.1 Relationship to Study Intervention ............................................................................. 40 
8.4.2 Expectedness ............................................................................................................ 40 
8.4.3 Severity of Event ....................................................................................................... 40 
8.4.4 Intervention ................................................................................................................ 40 
8.5 
Safety Reporting ........................................................................................................... 41 
8.5.1 Reporting to IRB ........................................................................................................ 41 
8.5.2 Unanticipated Problems ............................................................................................ 41 
8.5.3 Reporting to SKCC DSMC ........................................................................................ 41 
8.5.4 Reporting to Funding Company ................................................................................. 43 
8.5.5 Reporting of Pregnancy ............................................................................................. 46 
8.6 
Halting Rules ................................................................................................................. 46 
9 
Study Oversight .................................................................................................................... 46 
10 
Clinical Site Monitoring and Auditing ................................................................................ 47 
11 
Statistical Considerations .................................................................................................. 47 
11.1 
Study Hypotheses ......................................................................................................... 47 
11.2 
Analysis Plans ............................................................................................................... 47 
11.3 
Interim Analyses and Stopping Rules ............................................................................ 48 
11.3.1 
Safety Review ........................................................................................................ 48 

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11.3.2 
Efficacy Review ..................................................................................................... 48 
11.4 
Sample Size Considerations ......................................................................................... 48 
11.4.1 
Accrual Estimates .................................................................................................. 48 
11.5 
Exploratory Analysis ...................................................................................................... 48 
12 
Source Documents and Access to Source Data/Documents ............................................ 48 
13 
Quality Control and Quality Assurance ............................................................................. 49 
14 
Ethics/Protection of Human Participants ........................................................................... 49 
14.1 
Ethical Standard ............................................................................................................ 49 
14.2 
Institutional Review Board ............................................................................................. 49 
14.3 
Informed Consent Process ............................................................................................ 49 
14.4 
Exclusion of Women, Minorities, and Children (Special Populations) ........................... 49 
14.5 
Participant Confidentiality .............................................................................................. 50 
14.6 
Future Use of Stored Specimens and Other Identifiable Data ....................................... 50 
15 
Data Handling and Record Keeping ................................................................................. 50 
15.1 
Data Management Responsibilities ............................................................................... 50 
15.2 
Data Capture Methods .................................................................................................. 50 
15.3 
Types of Data ................................................................................................................ 51 
15.4 
Study Records Retention .............................................................................................. 51 
15.5 
Protocol Deviations ....................................................................................................... 51 
16 
Study Finances ................................................................................................................. 52 
16.1 
Funding Source ............................................................................................................. 52 
16.2 
Conflict of Interest ......................................................................................................... 52 
16.3 
Participant Stipends or Payments ................................................................................. 52 
17 
Publication and Data Sharing Policy ................................................................................. 52 
18 
Literature References ....................................................................................................... 53 
SUPPLEMENTAL MATERIALS ................................................................................................... 54 

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Appendices .................................................................................................................................. 55 

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Signature Page 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
 
Principal Investigator: 
 
 
Signed: 
Date: 
Name: 
 
Adam Binder 
Title: 
Assistant Professor 
 
 
Statement of Compliance 
This study will be conducted in accordance with the International Conference on Harmonisation 
guidelines for Good Clinical Practice (ICH E6), the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), and Thomas Jefferson University research 
policies 

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List of Abbreviations 
 
 
 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTSQ 
Cancer Treatment Satisfaction Questionnaire 
DSMC 
Data and Safety Monitoring Committee 
DSMP 
Data and Safety Monitoring Plan 
FDA 
Food and Drug Administration 
FWA 
Federalwide Assurance 
GCP 
Good Clinical Practice 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
OOCAT 
Oncology Opportunity Cost Assessment Tool 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PRC 
Protocol Review Committee 
QA 
Quality Assurance 
QC 
Quality Control 

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SAE 
Serious Adverse Event/Serious Adverse Experience 
SDS 
Safety Data Sheet (formerly MSDS; Material Safety Data Sheet) 
SKCC 
Sidney Kimmel Cancer Center 
SOP 
Standard Operating Procedure 
TJU 
Thomas Jefferson University 
UAP 
Unanticipated Problem 

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Study Summary 
 
 
Title: 
Open Label Single Arm Study to Assess the Implementation of 
Home based daratumumab administration. 
Précis: 
This study will include all patients on the monthly phase of 
daratumumab. Patient reported outcome metrics as well as 
implantation metrics will be measured. 
Objectives: 
Primary: Evaluate treatment burden (using the CTSQ). 
Secondary: 
1. Determine adherence to home delivery of Darzalex-Faspro. 
2. Evaluate quality of life (using EORTC QLQ-30) based on site 
of care (home vs. infusion center). 
3. Evaluate financial burden (using the COST survey) based on 
site of care (home vs. infusion center). 
4. Evaluate Safety of home administration of darzalex-faspro. 
5. Evaluate barriers to home administration. 
Exploratory: 
1. Evaluate patient perceptions of home administration of anti- 
neoplastic therapy 
2. Evaluate opportunity cost based on site of care (home vs. 
infusion center) using the Oncology Opportunity Cost 
Assessment Tool (OOCAT) 
Population: 
The sample size will be 20 participants. All patients with a diagnosis 
of multiple myeloma who are receiving the monthly phase of 
daratumumab. 
Phase: 
Pilot study 
Number of Sites: 
1- Sidney Kimmel Cancer Center 
Thomas Jefferson University 
925 Chestnut street, 4th floor 
Philadelphia, PA 19107 

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Description of 
Intervention: 
1) All participants included in the study will receive 
daratumumab subcutaneous injection therapy (fixed dose 
1800mg). On study, participants will receive 2 cycles of 
daratumumab in the infusion center, followed by 4 cycles at 
home followed by 2 more cycles at the infusion center. At the 
beginning of each cycle, patient reported outcome surveys 
and quality of life surveys will be collected (EORTC-QLQ-30, 
CTSQ, COST, and OOCAT). During the infusion center 
phase, administration will be given by an infusion center 
nurse. During the home infusion phase of the study a home 
infusion nurse will administer darzalex-faspro. During home 
administration, specific details on barriers to maintaining 
adherence will be collected and described with descriptive 
analysis (i.e. issues with storage, delivery, disposal of 
medication). 
Study Duration: 
36 months 
Participant 
Participation 
Duration: 
10 months 
Estimated Time to 
Complete 
Enrollment: 
26 months 

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Limited Physical Exam (may be virtual), ECOG assessment, AE assessment 
Labs: CBC, CMP, SPEP/IFE, Serum Immunoglobulins, Serum Free Light Chains, 
Surveys: CTSQ, EORTC QLQ-30, COST survey, OOCAT (To be performed 3-5 
days after the visit) 
Perform Barrier Assessment to home infusion 
Physical Exam, ECOG assessment, AE assessment 
Labs: CBC, CMP, SPEP/IFE, Serum Immunoglobulins, Serum Free Light Chains, 
Surveys: CTSQ, EORTC QLQ-30, COST survey, OOCAT (To be performed 3-5 
days after the visit) 
 
 
 
Perform Semi-structured 
qualitative interview 
AE Assessment 
Physical Exam, ECOG assessment, AE assessment 
Labs: CBC, CMP, SPEP/IFE, Serum Immunoglobulins, Serum Free Light Chains, 
Surveys: CTSQ, EORTC QLQ-30, COST survey, OOCAT (To be performed 3-5 
days after the visit) 
 
 
 
 
 
 
 
Arm 1: On monthly 
Daratumumab 
Total N: 20. Obtain informed consent. Screen potential subjects by inclusion and 
exclusion criteria; obtain medical history, prior/comcomitant medications, adverse 
event assessment, physical exam, ECOG, score, Baseline labs as per SOC (CBC, 
CMP). 
Schematic of Study Design: 
 
Screening Visit 
 
 
 
 
 
 
 
 
 
Visit 1-2 
C1D1 
C2D1 
 
 
Visit 3-6 
C3D1 
C4D1 
C5D1 
C6D1 
 
Visit 7-8 
C7D1 
C8D1 
 
 
 
 
 
Visit 9 
No later than 45 days 
After C8D1 
 
 
 
 
 
1 Introduction 
1.1 
Background Information 
Multiple myeloma is an incurable cancer of the plasma cells that can be complicated by 
hypercalcemia, renal failure, anemia, bone lesions, and recurrent infections. Over the last two 
decades the treatment paradigm for multiple myeloma has changed dramatically[1]. With the 
evolution of more effective treatments, patients are living longer with a better quality of life. As 

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part of this evolution, especially within the US, continuous treatment approach as opposed to 
intermittent treatment approach has become the standard of care[2]. However, these 
improvements come with a cost. Not only is the total cost of care extraordinary[3-5], but the 
financial burden on the patient is also high[6]. In one study, 46% of patients with a diagnosis of 
multiple myeloma had to use their savings to help pay for their cost of care and 71% 
experienced financial burden with 20% of respondents reporting severe financial burden[6]. 
In addition, to financial cost of care, treatment burden and exposure to the healthcare system 
must be considered. For many patients receiving anti-myeloma therapy, treatments require 
weekly visits to the cancer center resulting in hours of time spent traveling to, waiting for, and 
receiving treatment. Time that could be spent in the comfort of their homes. This is particularly 
important in the current pandemic, in which patients are encouraged to shelter in place in order 
to minimize exposures to SARS–CoV-2. A recent study published revealed that patients with 
multiple myeloma, regardless of their disease status, have a high mortality rate if they contract 
SARS-CoV-2[7]. As a result of this publication and other data, the American Society of 
Hematology continues to recommend minimizing patient exposure to the health care system 
and to consider changing to all oral therapy when able[8]. While this recommendation balances 
efficacy of treatment with risk of COVID-19, treatment efficacy is compromised as it has been 
well established that triplet or quadruplet (if dara containing regimen) is superior to doublet 
therapies [9-11]. 
For these reasons mentioned above, home-based chemotherapy, administered by a trained 
team, should be considered. Chemotherapy at home remains uncommon in the US, though 
models for its use exist globally[12]. In these models, home-based chemotherapy is safe, 
preferred by patients, and can be administered at lower cost. Given that the healthcare 
economics within the United States is not comparable to other systems where a national 
healthcare system exists, research into the implementation of and barriers to home based 
chemotherapy within the US is vital. This need is reinforced by a recent position statement 
published by ASCO[13]. Herein, we propose to evaluate the implementation of a home based 
subcutaneous daratumumab program for patients with multiple myeloma. We hypothesize that 
this program will be feasible, reduce patient treatment and financial burden, improve quality of 
life and at the same time, minimize risk to the patient during the COVID-19 pandemic without 
sacrificing treatment efficacy. 
 
 
1.2 
Rationale for the Proposed Study 
We propose to study the implementation of a home based anti-neoplastic therapy 
program with subcutaneous daratumumab and hyaluronidase-fihj (1800mg fixed dose). 
Home based chemotherapy has been well established in countries with national health 
care systems, but it has not been well studied within the US healthcare system. We plan 
to evaluate patient reported outcomes related to quality of life, treatment burden and 
cost burden of a home based anti-neoplastic therapy model. We will also evaluate the 
feasibility of delivering and administering anti-neoplastic therapy in the home. We 

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hypothesize that a home based anti-neoplastic therapy program will be feasible and 
improve quality of life while at the same time reduce treatment and cost burden. 
 
1.3 
Correlative Studies 
N/A 
 
1.4 
Potential Risks and Benefits 
1.4.1 
Potential Risks 
Potential risks associated with the administration of DARZALEX FASPRO in the home: 
 
• Potential for delay in treatment due to medication not being delivered. 
• Potential for missed doses or wasted doses of medication. 
 
 
1.4.2 
Benefits 
Potential benefits of the study include: 
 
• Improved quality of life while receiving medication in the home setting 
• Decreased cost of care during the study period 
• Decreased burden of care during the study period 
 
2 Study Objectives 
2.1 
Objectives 
2.1.1 
Primary 
1. Evaluate treatment burden (using the CTSQ). 
 
2.1.2 
Secondary 
1. Determine adherence to home delivery of DARZALEX FASPRO. 
 
2. Evaluate quality of life (using EORTC QLQ-30) based on site of care (home vs. 
infusion center). 
3. Evaluate financial burden (using the COST survey) based on site of care (home 
vs. infusion center). 
 
4. Evaluate Safety of home administration of darzalex-faspro. 
 
5. Evaluate barriers to home administration. 

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2.1.3 
Exploratory 
1. Evaluate patient perceptions of home administration of anti-neoplastic therapy. 
 
2. Evaluate opportunity cost based on site of care (home vs. infusion center) (using 
the OOCAT survey). 
 
2.2 
Endpoints/Outcome Measures 
2.2.1 
Primary 
1. Treatment satisfaction will be measured using the Cancer Treatment Satisfaction 
Questionnaire (CTSQ). 
 
2.2.2 
Secondary 
1. Adherence is defined as completing administration of medication in the home 
setting. Adherence will be measured for each dose given and failure would occur 
if the participant needs to go to the infusion center for administration for whatever 
reason. Based on previous studies of home based administration adherence 
rates over 75% would be needed to meet criteria for feasibility. 
2. Measurement of quality of life will be measured using the EORTC QLQ-30. 
 
3. Financial toxicity will be measured using the COST survey. 
 
4. Safety will be evaluated through collection of adverse events, administration 
reactions related to Darzalex-Faspro. 
 
5. Barriers to home administration will be measured through any delays in treatment 
related to delivery of medication, arrival time of the infusion nurse, issues related 
to storage of medication, issues related to administration of the medication. 
 
2.2.3 
Exploratory 
1. Patient perceptions of home based anti-neoplastic therapy will be measured 
through semi-structured interviews. 
 
2. Opportunity cost will be measured through the OOCAT survey. 
 
3 Study Design 
3.1 
Characteristics 
Open label, non-randomized trial in patients with multiple myeloma who are receiving 
DARZALEX FASPRO (daratumumab and hyaluronidase). 
 
3.2 
Number of Participants 
20 

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3.3 
Duration of Therapy 
8 months 
 
3.4 
Duration of Follow Up 
2 months 
 
3.5 
Treatment Assignment Procedures 
3.5.1 
Randomization Procedures (if applicable) 
N/A 
 
3.5.2 
Masking Procedures (if applicable) 
N/A 
 
3.6 
Study Timeline 
3.6.1 
Primary Completion 
26 months to complete study enrollment. 
 
3.6.2 
Study Completion 
36 months to study completion. 
 
4 Study Enrollment and Withdrawal 
4.1 
Eligibility Criteria 
4.1.1 
Inclusion Criteria 
Individuals must meet all of the following inclusion criteria in order to be eligible to 
participate in the study: 
 
1. Able to provide signed and dated informed consent form 
2. Willing to comply with all study procedures and be available for the duration of 
the study 
3. Male or female, aged greater than 18 years of age 
4. Has a diagnosis of Multiple Myeloma 
5. Is on the monthly phase of daratumumab (either IV or SubQ) based regimen 
(every 4 weeks) (either monotherapy or in combination with oral agents) 
6. Is willing to receive daratumumab subcutaneous injections 
7. Lives within the range of Jefferson Home Infusion Services 

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8. Patients are willing to allow home infusion company visit them and administer 
Darzalex-Faspro in the home. 
9. Women of reproductive potential must use highly effective contraception 
10. Men of reproductive potential must use highly effective contraception 
11. Adequate bone marrow function: ANC >1,000, Platelet Count > 50,000 
12. Adequate liver function: AST/ALT < 2.5 times ULN, Bilirubin <2 times ULN 
13. Adequate renal function: CrCl ≥ 20mL/min for single agent SC daratumumab. For 
combination studies: with lenalidomide ≥ 30mL/min 
14. English Speaking 
4.1.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation 
in this study: 
 
1. Receiving daratumumab for an indication other than multiple myeloma 
2. Receiving daratumumab in combination with other IV or subcutaneous therapy 
3. Pregnancy or lactation 
4. Known allergic reactions to components of the study product(s) 
5. Uncontrolled human immunodeficiency virus (HIV) 
 
6. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface 
antigen [HBsAg]) who are not on hepatitis B prophylaxis. Subjects with resolved 
infection (ie, subjects who are HBsAg negative but positive for antibodies to 
hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface 
antigen [anti-HBs]) must be screened using real-time polymerase chain reaction 
(PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR 
positive and not on Hep B prophylaxis will be excluded. EXCEPTION: Subjects 
with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the 
only serologic marker) AND a known history of prior HBV vaccination, do not 
need to be tested for HBV DNA by PCR. 
 
7. Patients with reactivation of hepatitis B will be excluded. 
 
8. Seropositive for hepatitis C (except in the setting of a sustained virologic 
response [SVR], defined as a viremia at least 12 weeks after completion of 
antiviral therapy). 
 
9. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume 
in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is 

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required for participants suspected of having COPD and participants must be 
excluded if FEV1 is < 50% of predicted normal. 
 
10. Moderate or severe persistent asthma within the past 2 years, or uncontrolled 
asthma of any classification. Note that participants who currently have controlled 
intermittent asthma or controlled mild persistent asthma are allowed to 
participate. 
 
11. Clinically significant cardiac disease, including: 
a. Myocardial infarction within 6 months before randomization, or unstable or 
uncontrolled disease/condition related to or affection cardiac function (e.g., 
unstable angina, congestive heart failure, New York Heart Association 
Class III-IV) 
b. Uncontrolled cardiac arrhythmia 
c. Screening 12-lead ECG showing a baseline QT interval as corrected by 
Fridericia's formula >470 msec 
 
• Non-English Speaking 
4.2 
Gender/Minority/Pediatric Inclusion for Research 
Women and individuals of ethnic and racial minorities will be included in the study. 
Interval evaluations will occur to ensure women and individuals of ethnic and racial 
minorities are being enrolled onto the study. Processes to increase enrollment for this 
population will occur if they are found to be underrepresented. Pediatric patients will not 
be included in the study, but Multiple Myeloma is not a disease of individuals under the 
age of 18. 
 
4.3 
Strategies for Recruitment and Retention 
 
Physicians, advanced practice practitioners or other supportive care staff will introduce 
the opportunity for clinical trial enrollment. We will collaborate with the SKCC’s 
Recruitment Enhancement Service (RES), a dedicated recruitment resource nested 
within the SKCC’s CRO that is available to all study teams. The goals of the RES are to 
reduce the burden of recruitment, to free up the time and resources of study teams, and 
to ensure teams meet recruitment goals on time. RES services include: (1) consulting 
with study teams to identify strategies for recruitment and retention of research 
participants; (2) searching the EHR to identify potential participants (e.g., searching by 
diagnostic labels and billing codes); (3) facilitating both paper and electronic contact of 
those individuals to invite their participation; and (4) enabling networking opportunities 
across Jefferson, its owned entities, and local community hospitals so that investigators 
can share recruitment resources. (5) Promoting studies via various mechanisms including 
social media. Overall, the RES model has successfully enrolled thousands of participants 
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collaborate with the SKCC’s Recruitment Enhancement Service (RES) to query the EHR 
system to identify participants who are eligible for this study. We may also leverage their 
existing relationships with community organizations and local hospitals, expertise in 
traditional and social media, and in-house resources for promotion of studies. This will 
include individuals with an ICD-9-CM (or ICD-10-CM) diagnostic code at either an office 
visit or on their list of known chronic conditions. 
Multiple contact methods will be obtained to maintain communication and follow up with 
participants. Extensive discussion of risks and possible benefits of study participation will 
be provided to participants and their families, if applicable. A consent form describing in 
detail the study procedures and risks will be given to the participant. Consent forms will 
be IRB-approved, and the participant is required to read and review the document or have 
the document read to him or her. The investigator or designee will explain the research 
study to the participant and answer any questions that may arise. The participant will sign 
the informed consent document prior to any study-related assessments or procedures. 
Participants will be given the opportunity to discuss the study with their surrogates or think 
about it prior to agreeing to participate. They may withdraw consent at any time 
throughout the course of the study. A copy of the signed informed consent document will 
be given to participants for their records. The rights and welfare of the participants will be 
protected by emphasizing to them that the quality of their clinical care will not be adversely 
affected if they decline to participate in this study. The consent process will be 
documented in the clinical or research record. 
4.4 
Participant Withdrawal 
4.4.1 
Reasons for Withdrawal 
Participants are free to withdraw from participation in the study at any time upon 
request. 
 
An investigator may terminate a study participant’s participation in the study if: 
 
• Any clinical adverse event (AE), laboratory abnormality, or other medical 
condition or situation occurs such that continued participation in the study would 
not be in the best interest of the participant. 
• The participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation. 
4.4.2 
Handling of Participant Withdrawals and Participant Discontinuation of 
Study Intervention 
Participants who withdraw or discontinue the study intervention early will continue to 
receive their treatment in the infusion center as per the standard of care. If a patient 
withdraws from study early, end of study visit (semi-structured qualitative interviews) will 

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be offered. If a participant withdraws or discontinues the study early, they may be 
replaced at the discretion of the sponsor and Principal Investigator. 
 
4.5 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, 
will be provided by the suspending or terminating party to the investigator, Janssen 
Scientific Affairs, LLC, regulatory authorities. If the study is prematurely terminated or 
suspended, the principal investigator will promptly inform the IRB and will provide the 
reason(s) for the termination or suspension. 
 
Circumstances that may warrant termination include, but are not limited to: 
 
• Determination of unexpected, significant, or unacceptable risk to participants. 
• Insufficient adherence to protocol requirements. 
• Data that is not sufficiently complete and/or evaluable. 
• Determination of futility. 
 
5 Study Intervention 
5.1 
Study Product 
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for subcutaneous (SC) 
administration 
 
5.1.1 
Daratumumab SC Dosing: 
All daratumumab administrations will be in an outpatient or home setting. Subjects will 
receive pre-injection medications and post-injection medication as outlined in Sections 
5.7.1 and 5.7.2, respectively. 
 
Vital signs should be monitored extensively on Cycle 1 Day 1 before, and after the first 
administration of daratumumab. Patients will be monitored for 3 hours after the first 
subcutaneous injection as per institutional protocol. For all other administrations, vital 
signs should be measured before the start of injection and at the end of the injection. If 
the subject experiences any significant medical event, then the investigator should 
assess whether the subject should stay overnight for observation. If the subject has not 
experienced a significant medical event but is hospitalized overnight only for 
observation, then the hospitalization should not be reported as an SAE. 
If an IRR develops, then the injection should be temporarily interrupted or slowed down. 
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or anaphylactic reaction, daratumumab SC should be discontinued, and no additional 
daratumumab SC should be administered to the participant. 
5.2 
Study Product Description 
5.2.1 
Acquisition 
The FDA approved product daratumumab and hyaluronidase-fihj will be supplied by the 
manufacturer during the home infusion phase of the study. During the infusion center 
phase of the study, the product will be acquired by the pharmacy. 
 
5.2.2 
Formulation, Packaging, and Labeling 
Injection: 1,800 mg daratumumab and 30,000 units hyaluronidase per 15 mL (120 mg 
and 2,000 units/mL) solution in a single-dose vial. 
 
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) injection is a sterile, 
preservative free, colorless to yellow, and clear to opalescent solution for subcutaneous 
use supplied as individually packaged single-dose vials providing 1,800 mg of 
daratumumab and 30,000 units of hyaluronidase per 15 mL (NDC 57894-503-01). 
 
5.2.3 
Product Storage and Stability 
Store DARZALEX FASPRO vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the 
original carton to protect from light. Do not freeze or shake. 
 
Once ready for use, it should be removed from refrigeration and equilibrate to ambient 
temperature [15°C to 30°C (59°F to 86°F)]. Store the unpunctured vial at ambient 
temperature and ambient light for a maximum of 24 hours. Keep out of direct sunlight. 
 
If the syringe containing DARZALEX FASPRO is not used immediately, store 
refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours and/or at room temperature 
at 15°C to 25°C (59°F to 77°F) for up to 12 hours under ambient light. 
 
Discard if storage time exceeds these limits. 
 
5.3 
If stored in the refrigerator, allow the solution to come to room temperature 
before administration.Dosage, Preparation, and Administration 
Daratumumab – Subcutaneous 
 
Daratumumab SC will be provided as a fixed-dose (1800 mg), combination drug product 
containing rHuPH20 drug substance (2000 U/mL) and daratumumab drug substance 
(120 mg/mL) in a single vial. 
Daratumumab Administration – Subcutaneous 

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[Daratumumab should be given according to product information: 
http://www.janssenlabels.com/package-insert/product-monograph/prescribing- 
information/DARZALEX+Faspro-pi.pdf] 
Daratumumab (1800 mg) will be administered by SC injection by manual push over 
approximately 3 – 5 minutes in the abdominal subcutaneous tissues in the left/right 
locations, alternating between individual doses. The volume of the SC solution will be 
15 mL for the 1800 mg dose. Reasons for continued observation on subsequent 
daratumumab injection may include but are not limited to the following: subjects with a 
higher risk of respiratory complications (e.g., subjects with mild asthma or subjects with 
COPD who have an FEV1 < 80% at screening or developed FEV1 < 80% during the 
study without any medical history), subjects with IRR with the first injection of study 
drug, subject with decreased condition on day of dosing compared to prior dosing day. 
The dose of daratumumab will remain constant throughout the study. 
5.4 
Dose Modifications and Dosing Delays 
No dose reductions of DARZALEX FASPRO are recommended. Consider withholding 
DARZALEX FASPRO to allow recovery of blood cell counts in the event of 
myelosuppression. 
 
Medication will be discontinued for life threatening hypersensitivity reactions. 
 
5.5 
Study Product Accountability 
Records of study medication used, dosages administered, and intervals between visits 
and the completion of the study should be captured in the Drug Accountability Form. 
This information must be captured in the source document at each patient visit. 
 
At the conclusion of the study, and, as appropriate during the course of the study, all 
unused drug will be properly destroyed and discarded. 
 
 
5.6 
Assessing Participant Compliance with Study Product Administration 
Regular monitoring will take place to assess participant compliance with completion of 
the questionnaires. Research coordinators will review Redcap to ensure questionnaires 
are completed in a timely manner when these questionnaires are being completed 
electronically (during the home infusion phase of the study). 
 
5.7 
Concomitant Medications/Treatments 
5.7.1 
Pre-dose Medications for Prevention of Injection Reactions 
All participants will receive the following medications 1 to 3 hours prior to each study 
drug administration: 

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• An antipyretic: paracetamol (acetaminophen) 650-1000 mg IV or PO 
• An antihistamine: diphenhydramine 25-50 mg IV or PO or equivalent. Avoid IV 
use of promethazine. 
o After Cycle 6, if a participant has not developed an infusion-related 
reaction and is intolerant to antihistamines, modifications are acceptable 
as per investigator discretion. 
• Corticosteroids (Long-acting or intermediate-acting): 
o Monotherapy: Methylprednisolone 100 mg, or equivalent, administered 
intravenously. Following the second infusion, the dose of corticosteroid 
may be reduced (oral or intravenous methylprednisolone 60 mg or 
equivalent). 
o Combination therapy: 
 Administer 20 mg dexamethasone (or equivalent) prior to every 
daratumumab infusion. When dexamethasone is the background 
regimen specific corticosteroid, the dexamethasone treatment dose 
will instead serve as pre-medication on daratumumab infusion 
days. 
 Dexamethasone is given orally or intravenously prior to the first 
daratumumab infusion and oral administration may be considered 
prior to subsequent infusions. 
o If the subject does not experience a major systemic administration-related 
reaction after the first 3 doses, consider discontinuing the administration of 
corticosteroids (excluding any background regimen-specific 
corticosteroid). 
o As per institutional guidelines, a leukotriene inhibitor (montelukast 10 mg 
PO or equivalent) is optional in Cycle 1 Day 1 and can be administered up 
to 24 hours before infusion as per investigator discretion. 
If necessary, all PO pre-infusion medications may be administered out of the clinic on 
the day of the infusion, provided they are taken within 3 hours before administration. In 
the home setting, similarly, patients may take their premedication prior to the nurse 
arrival provided they are taken within 3 hours of Darzalex-Faspro administration. 
5.7.2 
Post-dose Medication: 
Administer post-infusion medication to reduce the risk of delayed infusion related 
reactions as follows: 
• Monotherapy studies: 
o In an effort to prevent delayed infusion-related reactions, all participants 
will receive long- or intermediate-acting corticosteroid orally (20 mg 
methylprednisolone or equivalent in accordance with local standards) on 
the 2 days following all daratumumab infusions (beginning the day after 
the infusion). 
o In the absence of infusion related AEs after the first 3 infusions, post- 
infusion corticosteroids should be administered per investigator discretion. 
• Combination therapy: 

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o Consider administering low-dose methylprednisolone (≤ 20 mg) or 
equivalent, the day after the infusion. However, if a background regimen- 
specific corticosteroid (e.g. dexamethasone) is administered the day after 
the infusion, additional post-infusion steroids are not required, but may be 
considered by the investigator. 
• For all studies: 
o For participants with a higher risk of respiratory complications (e.g. 
participants with mild asthma or participants with COPD who have an 
FEV1 < 80% at screening or developed FEV1 < 80% during the study 
without any medical history) the following post-infusion medication should 
be considered: 
 Antihistamine (diphenhydramine or equivalent) 
 Leukotriene inhibitor (montelukast or equivalent) 
 Short-acting β2 adrenergic receptor agonist such as salbutamol 
aerosol 
 Control medications for lung disease (e.g. inhaled corticosteroids ± 
long-acting β2 adrenergic receptor agonists with asthma; long- 
acting bronchodilators such as tiotropium or salmeterol ± inhaled 
corticosteroids for participants with COPD) 
o In addition, these at-risk participants may be hospitalized for monitoring for 
up to 2 nights after daratumumab administration. If participants are 
hospitalized, then an improvement in FEV1 should be performed and 
documented prior to discharge. If these participants are not hospitalized, 
then a follow-up telephone call should be made to monitor their condition 
within 48 hours after all infusions. If the participant has not experienced a 
significant medical event but is hospitalized overnight only for observation, 
then the hospitalization should not be reported as a serious adverse 
event. Investigators may prescribe bronchodilators, H1-antihistamines, 
and corticosteroids that are deemed necessary to provide adequate 
supportive care in the event a bronchospasm occurs after participants are 
released from the hospital/clinic. If an at-risk participant experiences no 
major infusion-related reactions, then these post-infusion medications may 
be waived after 4 doses at the investigator’s discretion. 
o Any post-infusion medication will be administered after the infusion has 
completed. 
 
5.7.3 
Prophylaxis for Herpes Zoster 
• Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week 
after starting DARZALEX FASPRO and continue for 3 months following the end 
of treatment 
5.7.4 
Prophylaxis and Management of Hepatitis B Reactivation 
• Prophylaxis for Herpes Zoster Reactivation: 
o Prophylaxis for herpes zoster reactivation is recommended during the 
Treatment Phase, as per institutional guidelines. Initiate antiviral 

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prophylaxis to prevent herpes zoster reactivation within 1 week after 
starting study treatment and continue for 3 months following study 
treatment. Acceptable antiviral therapy includes acyclovir (eg 400 mg 
given orally 3 times a day, or 800 mg given orally 2 times a day or per 
institutional standards), famcyclovir (eg, 125 mg given orally, twice a day 
or per institutional standards), or valacyclovir (eg, 500 mg given orally, 
twice a day or per institutional standards), initiated within 1 week after the 
start of study drug. 
• Management of Hepatitis B Virus Reactivation: 
o Primary antiviral prophylaxis is permitted as per local standard of care. Per 
protocol, HBV DNA testing by PCR is mandatory for participants at risk for 
HBV reactivation. 
o In patients who develop reactivation of HBV while on study treatment, 
suspend treatment with study treatment and any concomitant steroids, 
anti-neoplastic therapy, and institute appropriate treatment. Resumption of 
study treatment in patients whose HBV reactivation is adequately 
controlled should be discussed with physicians with expertise in managing 
HBV. 
5.8 
Dietary Restrictions 
None 
 
6 Study Schedule 
6.1 
Pretreatment Period/Screening 
Screening Visit (Day -30 to -1) 
• Obtain and document consent from potential participant on study consent form. 
• Review medical history to determine eligibility based on inclusion/exclusion 
criteria. 
• Review medications history to determine eligibility based on inclusion/exclusion 
criteria. 
• Perform medical examinations needed to determine eligibility. 
• Document ECOG performance status 
• Collect screening labs: CBC, CMP, SPEP, sFLC, Serum Immunoglobulins, 
Pregnancy Test (serum or urine) for women of child bearing potential 
• Document Current Multiple Myeloma Disease Status 
• Schedule study visits for individuals who are eligible and available for the 
duration of the study. 
6.2 
Treatment Period 

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Initial Visit (Visit 1, Day 1) 
• Verify inclusion/exclusion criteria. 
• Document any changes in Medical History, Concomitant Medications 
• Perform and record physical exam findings. 
• Document ECOG performance status 
• Collect labs: CBC, CMP, SPEP, sFLC, Serum Immunoglobulins 
• Document Current Multiple Myeloma Disease Status 
• Complete the following surveys electronically (Surveys will be completed 3-5 
days after the treatment day): 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Administer DARZALEX FASPRO in the infusion center. No observation period 
needed. 
 
 
 
Visit 2, Day 29 ± 3 days 
 
• Record adverse events as reported by participant or observed by investigator. 
• Document any changes in Medical History, Concomitant Medications 
• Perform and record physical exam findings. 
• Document ECOG performance status 
• Collect labs: CBC, CMP, SPEP, sFLC, Serum Immunoglobulins 
• Document Current Multiple Myeloma Disease Status 
• Complete the following surveys electronically (Surveys will be completed 3-5 
days after the treatment day): 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Administer DARZALEX FASPRO in the infusion center. No observation period 
needed. 

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Visit 3 Day 57 ± 3 days 
• Record adverse events as reported by participant or observed by investigator 
(visit with provider may take place via telehealth). 
• Document any changes in Medical History, Concomitant Medications 
• Perform and record physical exam findings (may be limited if performed virtually) 
by APP or physician prior to home nursing visit. 
• Document ECOG performance status 
• Collect Cycle 3Day 1 labs: CBC, CMP, SPEP, sFLC, Serum Immunoglobulins, 
(Labs should be drawn 24-48 hours prior to injection date, can be collected in the 
patients home, local clinic, or at a local laboratory or at the main academic 
hospital) 
• Document Current Multiple Myeloma Disease Status 
• Complete the following surveys electronically (Surveys will be completed 3-5 
days after the treatment day): 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Barriers Assessment 
o Delay in anti-neoplastic therapy, delivery of medication, nurse arrival 
o Any wasted drug 
o Issues with storage or disposal of medication 
o Other issues that arise 
• Patient to take Pre-meds prior to nurse arrival 
• Administer DARZALEX FASPRO at home. No observation period needed. 
 
Visit 4 Day 85 ± 3 days 
• Record adverse events as reported by participant or observed by investigator 
(visit with provider may take place via telehealth). 
• Document any changes in Medical History, Concomitant Medications 
• Perform and record physical exam findings (may be limited if performed virtually). 
• Document ECOG performance status 

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• Collect Cycle 4 Day 1 labs: CBC, CMP, SPEP, sFLC, Serum Immunoglobulins 
(Labs should be drawn 24-48 hours prior to injection date) 
• Document Current Multiple Myeloma Disease Status 
• Complete the following surveys electronically (Surveys will be completed 3-5 
days after the treatment day): 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Barriers Assessment 
o Delay in anti-neoplastic therapy, delivery of medication, nurse arrival 
o Any wasted drug 
o Issues with storage or disposal of medication 
o Other issues that arise 
• Patient to take Pre-meds prior to nurse arrival 
• Administer DARZALEX FASPRO at home. No observation period needed. 
 
Visit 5 Day 113 ± 3 days 
• Record adverse events as reported by participant or observed by investigator 
(visit with provider may take place via telehealth). 
• Document any changes in Medical History, Concomitant Medications 
• Perform and record physical exam findings (may be limited if performed virtually). 
• Document ECOG performance status 
• Collect Cycle 5 Day 1 labs: CBC, CMP, SPEP, sFLC, Serum Immunoglobulins 
(Labs should be drawn 24-48 hours prior to injection date) 
• Document Current Multiple Myeloma Disease Status 
• Complete the following surveys electronically (Surveys will be completed 3-5 
days after the treatment day): 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Barriers Assessment 

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o Delay in anti-neoplastic therapy, delivery of medication, nurse arrival 
o Any wasted drug 
o Issues with storage or disposal of medication 
o Other issues that arise 
• Patient to take Pre-meds prior to nurse arrival 
• Administer DARZALEX FASPRO at home. No observation period needed. 
 
Visit 6 Day 141 ± 3 days 
• Record adverse events as reported by participant or observed by investigator 
(visit with provider may take place via telehealth). 
• Document any changes in Medical History, Concomitant Medications 
• Perform and record physical exam findings (may be limited if performed virtually). 
• Document ECOG performance status 
• Collect Cycle 6 Day 1 labs: CBC, CMP, SPEP, sFLC, Serum 
Immunoglobulins(Labs should be drawn 24-48 hours prior to injection date) 
• Document Current Multiple Myeloma Disease Status 
• Complete the following surveys electronically(Surveys will be completed 3-5 days 
after the treatment day): 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Barriers Assessment 
o Delay in anti-neoplastic therapy, delivery of medication, nurse arrival 
o Any wasted drug 
o Issues with storage or disposal of medication 
o Other issues that arise 
• Patient to take Pre-meds prior to nurse arrival 
• Administer DARZALEX FASPRO at home. No observation period needed. 
 
Visit 7 Day 169 ± 3 days 
• Record adverse events as reported by participant or observed by investigator 
• Document any changes in Medical History, Concomitant Medications 

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• Perform and record physical exam findings. 
• Document ECOG performance status 
• Collect Cycle 7 Day 1 labs: CBC, CMP, SPEP, sFLC, Serum Immunoglobulins 
• Document Current Multiple Myeloma Disease Status 
• Complete the following surveys electronically (Surveys will be completed 3-5 
days after the treatment day): 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Administer DARZALEX FASPRO in the infusion center. No observation period 
needed. 
 
Visit 8 Day 197 ± 3 days 
• Record adverse events as reported by participant or observed by investigator. 
• Document any changes in Medical History, Concomitant Medications 
• Perform and record physical exam findings. 
• Document ECOG performance status 
• Collect Cycle 8 Day 1 labs: CBC, CMP, SPEP, sFLC, Serum Immunoglobulins, 
LDH, Uric Acid 
• Document Current Multiple Myeloma Disease Status 
• Complete the following surveys electronically (Surveys will be completed 3-5 
days after the treatment day): 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Administer DARZALEX FASPRO in the infusion center. No observation period 
needed. 
6.3 
End of Treatment Study Procedures 
Final Study Visit (Visit 9, Day 198 + 45 days) 
 
• Record adverse events as reported by participant or observed by investigator 
(visit with provider may take place via telehealth). 

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• Perform and record physical exam findings. 
• Document ECOG performance status 
• Perform semi-structured qualitative interview with patient to evaluate perceptions 
of home vs. infusion center based administration of treatment. 
6.4 
Post-treatment/Follow-Up 
N/A 
 
6.5 
Long Term/Survival Follow-up 
N/A 
 
7 Study Procedures and Evaluations 
7.1 
Study Procedures/Evaluations 
• Medical History – Includes documentation of the patient’s medical history at time 
of enrollment and any changes that occur during the duration of the study. 
 
• Medication History – Includes documentation of the patient’s medication list at 
time of enrollment and any changes that occur during the duration of the study. 
Includes both prescription and over the counter medications. 
 
• The following Questionnaires will be administered either in person and completed 
on a tablet or remotely through a link that will be distributed via the participants 
email. 
 
o Cancer Treatment Satisfaction Survey 
o EORTC QLQ-C30 
o COST Survey 
o OOCAT Survey 
• Semi Structures Qualitative Interview will be conducted. Interviews will be 
conducted by a member of the research team. All interviews will be recorded and 
transcribed. 
• Barrier Assessment of home administration of anti-neoplastic therapy. 
o Delay in anti-neoplastic therapy, delivery of medication, nurse arrival 
o Any wasted drug 
o Issues with storage or disposal of medication 
7.2 
Laboratory Procedures/Evaluations 
7.2.1 
Clinical Laboratory Evaluations 

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HBV Serology: All subjects will be tested locally for hepatitis B surface antigen (HBsAg), 
hepatitis B surface antibody (Anti-HBs), and hepatitis B core antibody (Anti-HBc) at 
Screening. 
HBV DNA Tests: Subjects who are positive for Anti-HBc or Anti-HBs will undergo testing 
for hepatitis B DNA by PCR. Subjects with serologic findings suggestive of HBV 
vaccination (Anti-HBs positivity as the only serologic marker) and a known history of 
prior HBV vaccination do not need to be tested for HBV DNA by PCR. During and 
following study treatment, subjects who have history of HBV infection will be closely 
monitored for clinical and laboratory signs of reactivation of HBV as per institutional 
policy. 
All other laboratory studies are per standard of care and per institutional guidelines 
for management and monitoring of patients with multiple myeloma. 
7.2.2 
Special Assays or Procedures 
N/A 
 
7.2.3 
Specimen Preparation, Handling, and Storage 
N/A 
 
7.2.4 
Specimen Shipment 
N/A 
 
8 Evaluation of Safety 
8.1 
Specification of Safety Parameters 
8.1.1 
Product Quality Complaints 
A PQC may have an impact on the safety and efficacy of a Company product. Timely, 
accurate, and complete reporting and analysis of PQC information from studies are crucial 
for the protection of patients, investigators, and the Company, and are mandated by 
regulatory agencies worldwide. The Company has established procedures in conformity 
with regulatory requirements worldwide to ensure appropriate reporting of PQC information. 
The Institution agrees that Lot and/or Batch #s shall be collected, when available, for all 
PQC reports, including reports of failure of expected pharmacological action (i.e., lack of 
effect) of a Janssen Medicinal Product. A sample of the suspected product shall be 
maintained for further investigation if requested by the Company. 

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Any complaint that indicates a potential quality issue during manufacturing, packaging, 
release testing, stability monitoring, dose preparation, storage or distribution of the product 
or delivery system is considered a PQC. Not all PQCs involve a patient. 
 
Examples of PQC include but are not limited to: 
• 
Mislabelling or misbranding 
• 
Information concerning microbial contamination, including a suspected transmission 
of any infectious agent by a product 
• 
Any significant chemical, physical, or other changes that indicate deterioration in the 
distributed product 
• 
Any foreign matter reported to be in the product 
• 
Mixed product, e.g., two drugs are mixed-up in the packaging process 
• 
Incorrect tablet sequence (e.g., oral contraceptive tablets) 
• 
Insecure closure with serious medical consequences, e.g., cytotoxics, child-resistant 
containers, potent drugs 
• 
Suspected counterfeit or tampered product 
 
• 
Adverse Device Effects including any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, implantation, installation, 
operation, or any malfunction of a medical device or combination product. This also 
includes any event that is a result of a use error or intentional misuse and dosing 
device malfunctions (e.g. auto-injector button not working, needle detaching from 
syringe, etc.) 
• 
Physical defect (e.g. abnormal product odor, broken or crushed tablets, etc.) 
 
8.1.2 
Unanticipated Problems 
Unanticipated problems (UAPs) include, in general, any incident, experience, or 
outcome that meets the following criteria: 
 
• unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; 
UAPs are considered to pose risk to participants or others when they suggest that the 
research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
8.1.3 
Adverse Events 
An adverse event is any untoward or unfavorable medical occurrence in a human 
participant, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the participant’s 
participation in the research, whether or not considered related to the participant’s 
participation in the research. 
 
8.1.4 
Adverse Events of Special Interest 

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Adverse events of special interest are events that Janssen Scientific Affairs, LLC is 
actively monitoring as a result of a previously identified signal (even if non-serious). 
Adverse events of special interest of daratumumab will be reported to the Company as 
defined in the protocol. In case of any amendments to the AESI list, Company will notify 
the Institution/Investigator and the Institution/Investigator will inform sites. 
Institution/Investigator will ensure that these changes are updated in the protocol as 
soon as practical. 
Adverse events of special interest are events that the COMPANY is actively monitoring 
as a result of a previously identified signal (even if non-serious). 
 
These adverse events are: 
• Infusion reactions: ≥ Grade 3 
• Infections: ≥ Grade 4 
• Cytopenias: ≥ Grade 4 
• HBV Reactivation 
• Other malignancies 
 
8.1.5 
Serious Adverse Events 
A serious adverse event (SAE) is one that meets one or more of the following criteria: 
 
• Results in death 
• Is life-threatening (places the participant at immediate risk of death from the 
event as it occurred) 
• Is disabling or incapacitating 
• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect 
• An important medical event that may not result in death, be life threatening, or 
require hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, the event may jeopardize the participant or may require 
intervention to prevent one of the outcomes listed in this definition. 
• 
Is considered medically significant* 
 
 
*Any untoward medical occurrence that is considered medically significant. Medical and 
scientific judgment should be exercised in deciding whether expedited reporting is appropriate in 
other situations, such as important medical events that may not result in death, be life- 

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threatening or require hospitalization but may be considered a serious adverse drug experience 
when, based on appropriate medical judgement, that may jeopardize the patient or subject and 
may require medical or surgical intervention to prevent one of the other outcomes listed in the 
bulleted list above. Examples of such medical events include allergic bronchospasm requiring 
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do 
not result in hospitalization, or development of drug dependency or drug abuse or malignancy. 
8.1.6 
Hospitalizations 
 
For reports of hospitalization, it is the sign, symptom or diagnosis which led to 
hospitalization that is the serious event for which details must be provided. Any event 
requiring hospitalization or prolongation of hospitalization that occurs during a study 
must be reported as a serious adverse event, except hospitalizations for the following: 
• Hospitalizations not intended to treat an acute illness or adverse event (e.g., social 
reasons such as pending placement in long-term care facility) 
• Surgery or procedure planned before entry into a study. [Note: Hospitalizations 
that were planned before the signing of ICF and where the underlying condition 
for which the hospitalization was planned has not worsened will not be considered 
serious adverse events. Any adverse event that results in a prolongation of the 
originally planned hospitalization is to be reported as a new serious adverse 
event.] 
 
8.1.7 
Life-threatening Conditions 
Disease progression should not be recorded as an adverse event or serious adverse event 
term; instead, signs and symptoms of clinical sequelae resulting from disease 
progression/lack of efficacy will be reported if they fulfil the serious adverse event definition. 
If no SAE is associated with the special situation, the special situation should be 
recorded in the CRF and sent annually to Janssen Scientific Affairs, LLC. 
These safety events may not meet the definition of an adverse event; however, the 
Parties agree that for reporting purposes, they are deemed to be adverse events. 
8.1.8 
Special Situations 
 
 
The following special situations must be reported to Company with or without an 
associated serious adverse event (SAE): 
• 
Drug exposure during pregnancy (paternal, maternal) 
 
• 
Suspected transmission of any infectious agent via administration of a Janssen 
Product(s) under study. 

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The following special situations must be reported to the Company when associated 
with a serious adverse event (SAE): 
• 
Overdose of Janssen Product(s) under study 
 
• 
Exposure to Janssen Product(s) under study from breastfeeding 
 
• 
Suspected abuse/misuse of Janssen product(s) under study 
 
• 
Inadvertent or accidental exposure to Janssen Product(s) under study 
 
• 
Any failure of expected pharmacological action (i.e., lack of effect) of Janssen 
Product(s) under study 
• 
Medication error (includes potential, intercepted or actual) involving a Janssen 
product (with or without patient exposure to the Janssen Product(s) under study, 
e.g., name confusion) 
• 
Unexpected therapeutic or clinical benefit from use of Janssen Product(s) under 
study 
8.2 “Extraordinary” correspondence 
Correspondence with a regulatory authority or ethics committee regarding a safety 
issue that may impact the safety or benefit-risk balance of the Janssen Product(s) 
Under Study, and/or may impact patients or public health. Examples include: 
• Safety issues relating to a quality defect 
• Major safety issues identified with changes in the nature, severity or frequency 
of known serious adverse reactions which are medically significant or the 
detection of new risk factors for the development of a known adverse reaction 
or a new serious adverse reaction. 
• 
Major safety issues identified in the context of ongoing or newly completed 
post-marketing studies e.g. an unexpected increased rate of fatal or life- 
threatening adverse events. 
 
8.3 
Safety Assessment and Follow-Up 
The PI will follow adverse events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day 
of study participation. At each study visit, the investigator (or designee) will inquire 
about the occurrence of AE/SAEs since the last visit. Events will be followed for 
outcome information until resolution or stabilization. 
 
8.4 
Recording Adverse Events 
 
If no SAE is associated with the special situation, the special situation should be 
recorded in the CRF and sent annually to the Company. 

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These safety events may not meet the definition of an adverse event; however, the 
Parties agree that for reporting purposes, they are deemed to be adverse events. 
“Safety Assessment and Follow-Up 
 
8.4.1 
Relationship to Study Intervention 
The relationship to study intervention or study participation must be assessed and 
documented for all adverse events. Evaluation of relatedness must consider etiologies 
such as natural history of the underlying disease, concurrent illness, concomitant 
therapy, study-related procedures, accidents, and other external factors. 
 
The following guidelines are used to assess relationship of an event to study 
intervention: 
 
1. Related (Possible, Probable, Definite) 
 
a. The event is known to occur with the study intervention. 
 
b. There is a temporal relationship between the intervention and event onset. 
 
c. The event abates when the intervention is discontinued. 
 
d. The event reappears upon a re-challenge with the intervention. 
 
2. Not Related (Unlikely, Not Related) 
 
a. There is no temporal relationship between the intervention and event 
onset. 
 
b. An alternate etiology has been established. 
 
8.4.2 
Expectedness 
The PI is responsible for determining whether an AE is expected or unexpected. An AE 
will be considered unexpected if the nature, severity, or frequency of the event is not 
consistent with the risk information previously described for the intervention. Risk 
information to assess expectedness can be obtained from preclinical studies, the 
investigator’s brochure, published medical literature, the protocol, or the informed 
consent document. 
 
8.4.3 
Severity of Event 
Adverse events will be graded for severity according to the Common Terminology 
Criteria for Adverse Events (CTCAE) version 5.0 
 
8.4.4 
Intervention 
Any intervention implemented to treat the adverse event must be documented for all 
adverse events. 

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8.5 
Safety Reporting 
8.5.1 
Reporting to IRB 
 
 
8.5.2 
Unanticipated Problems 
 
All incidents or events that meet criteria for unanticipated problems (UAPs) as defined in 
Section 8.1.2 require the creation and completion of an unanticipated problem report form 
(OHR-20). 
 
UAPs that pose risk to participants or others, and that are not AEs, will be submitted to 
the IRB on an OHR-20 form via the eazUP system within 10 working days of the 
investigator becoming aware of the event. 
 
UAPs that do not pose risk to participants or others will be submitted to the IRB at the 
next continuing review. 
 
8.5.2.1 Adverse Events 
Grade 1 AEs will be reported to the IRB at continuing review. 
 
Grade 2 AEs will be reported to the IRB at the time of continuing review. 
 
8.5.2.2 Serious Adverse Events 
SAEs will be reported to the IRB on OHR-10 forms via the electronic reporting system 
(eSAEy) according to the required time frames described below. 
 
Grade 3-4 AEs that are unexpected and deemed to be at least possibly related to the 
study will be reported to the IRB within 2 working days of knowledge of the event. 
 
Grade 3-4 AEs that are deemed unrelated to the study will be reported to the IRB within 
5 working days. 
 
Grade 5 AEs will be reported to the IRB within one working day of knowledge of the 
event. 
 
All SAEs will be submitted to the IRB at continuing review, including those that were 
reported previously. 
 
8.5.3 
Reporting to SKCC DSMC 
All AEs and SAEs, safety and toxicity data, and any corrective actions will be submitted 
to the DSMC per the frequency described in the SKCC DSMP. The report to the SKCC 
DSMC will also include any unanticipated problems that in the opinion of the PI should 
be reported to the DSMC. 

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For expedited reporting requirements, see table below: 
DSMC AE/SAE Reporting Requirements 
 

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8.5.4 
Reporting to Funding Company 
 
8.5.4.1 Sponsor Responsibilities 
 
8.5.4.1.1 Health Authority 
The Institution/Investigator shall be solely responsible for complying, within the required 
timelines, with any safety reporting obligation towards the competent health authorities, the 
Ethics Committees (EC) or Independent Review Board (IRB) and the participating (co- or 
sub-) investigators. 
8.5.4.1.2 General 
The Institution / Investigator shall notify Janssen immediately in case of a suspension of 
recruitment or premature stop of the concerned clinical study because of a safety concern; 
preferably by means of a telephone contact with the Company Representative, alternatively by 
email within twenty-four (24) hours of the decision. 
 
Institution / Investigator shall provide to the Janssen copies of any and all relevant extraordinary 
(not including routine initial or follow-up ICSR submission) correspondences with health authorities 
and ethics committees regarding any and all serious adverse events (irrespective of the 
association with the Janssen Product(s) Under Study). Copies of such correspondence shall be 
provided within 24 hours of such report or correspondence being sent to applicable health 
authority. 
 
Training: Institution of the Study shall be responsible for training the Study personnel (including 
the Investigator) on managing safety information arising from the Study according to agreed 
procedures and the requirements of this Agreement. 
 
Management of Safety Data: The Institution and Investigator will provide safety information arising 
from the Study to the Company on adverse events, special situations including pregnancies and 
product quality complaints as defined within this exhibit. This safety information will be 
documented by the Investigator and reported as described in this exhibit from the time a subject 
has signed and dated an Informed Consent Form (ICF) until 30 days after the last dose of the 
Janssen Product(s) Under Study. All subsequent AEs and SAEs beyond 30 days after the last 
dose of the Janssen Product(s) under study shall be collected/reported if the investigator considers 
the AE/SAE to be causally related to the use of the Janssen Product(s) Under Study. 
 
For the purposes of this Study, the Janssen Product(s) Under Study is (are): 
 
DARZALEX FASPRO® (daratumumab hyaluronidase-fihj) 
 
Maintenance of Safety Information: All safety data arising from the Study shall be 
maintained in a clinical database in a retrievable format. The Institution and Investigator 
shall provide a summary of all non-serious adverse events (NSAES) annually, and both 
serious and non-serious adverse events will be summarized in the final Study report 
(excluding those from subjects not exposed to a Janssen product). The summary shall 
include a listing of: Patient ID, adverse event term (uncoded), severity, relationship to 
Janssen Product(s) Under Study, and action taken with Janssen Product(s) Under Study. 
However, in certain circumstances more frequent provision of safety data may be 

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necessary, e.g. to fulfill a regulatory request, and as such the safety data shall be made 
available within a reasonable timeframe at the Company’s request. 
Follow-up: All (serious and non-serious) adverse events reported for a Janssen 
Product(s)Under Study shall be followed up in accordance with good clinical practice 
(GCP). 
If batch/lot number is available, it must be reported. If batch/lot number is not available, it 
must be documented that it is not available. Without this documentation, Company is 
required to perform two follow-up attempts to obtain the batch/lot number. 
8.5.4.2 Reporting of Safety data and Product Quality Complaints (PQCs) to 
Company 
All adverse events and special situations, whether serious or non-serious, related or not related, 
collected as per protocol design, following exposure to a Janssen Product(s) Under Study are to 
be documented by the investigator and recorded in the CRF and in the subject’s source records. 
Investigators must record in the CRF their evaluation concerning the relationship of the adverse 
event to a Janssen Product(s) Under Study. 
 
The Institution will submit (and procure that the Investigator submits), to the identified Company 
Representative in each Country/Territory the following safety information: 
 
Type of report 
Timelines 
How to report 
Serious Adverse Event, 
Within 3 business days of 
becoming aware of the event(s) 
By a secure means, as agreed 
by the Parties, on a Serious 
Adverse Event Form. 
Adverse Events of Special 
Interest (AESI) 
Within 3 business days of 
becoming aware of the event(s) 
By a secure means, as agreed 
by the Parties, on a Serious 
Adverse Event Form. 
Reports of drug exposure 
during pregnancy (maternal and 
paternal), with or without SAE. 
Within 3 business days of 
becoming aware of the event(s) 
By a secure means, as agreed 
by the Parties, on a Pregnancy 
Notification   Form/Serious 
Adverse Event Form. 
Reports of Suspected 
transmission of any infectious 
agent via administration of a 
Janssen Product, with or 
without an SAE 
Within 3 business days of 
becoming aware of the event(s) 
By a secure means, as agreed 
by the Parties, on a Serious 
Adverse Event Form. 
Abnormal Pregnancy Outcomes 
(e.g. spontaneous abortion, 
fetal death, stillbirth, congenital 
anomaly, ectopic pregnancy) 
Within 3 business days of 
becoming aware of the event(s) 
By a secure means, as agreed 
by the Parties, on a Serious 
Adverse Event Form. 
Special 
Situation 
(SS), 
if 
associated with an SAE 
Within 3 business days of 
becoming aware of the event(s) 
By a secure means, as agreed 
by the Parties, on a Serious 
Adverse Event Form. 
Special Situation (not associated 
with an SAE) 
Annually and in final study 
report. 
Recorded in CRF and reported 
annually and in final study 
report. 

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Product Quality Complaints 
Within 3 business days of 
becoming aware of the event(s) 
By a secure means, as agreed 
by the Parties. 
Non-Serious Adverse Event* 
(*Not meeting other listed 3 
business day reporting criteria 
e.g. AESI or SS) 
Annually and in final study 
report. 
Recorded in CRF and reported 
annually and in final study 
report. 
Follow-up information 
Transmitted within the same 
timeframes as above i.e. if initial 
report was required to be 
submitted within 3 business 
days, follow-up information shall 
be submitted within the same 
timeframe. 
Transmitted via same method 
as above i.e. if initial method of 
transmission was on an SAE 
form, follow-up information 
shall be transmitted in the 
same manner. 
 
The Institution and/or Investigator is responsible for ensuring that these cases are complete 
and if not, are promptly followed-up. A safety report is not considered complete until all 
clinical details needed to interpret the case are received. 
Note: In the event the Study is blinded, the Investigator will submit an unblinded SAE or 
pregnancy exposure report to Company. 
If the Investigator/agent of the Investigator receives safety information and is aware it 
involves a non-study J&J product, it will be reported to Company, indicating it is an 
incidental spontaneous report discovered during the course of the study. 
8.5.4.3 Funder confirmation/review of SAEs 
 
Company Representative or designee will provide the Institution and Investigator with a list 
of the Study’s SAEs (previously received by the Company from the Institution and the 
Investigator) on a semi-annual basis. Investigator will confirm to Company that all applicable 
SAEs related to Janssen Product(s) Under Study have been reported to Company. The 
principle investigator has the responsibility of reporting to the health authorities. 
• Funder Responsibilities 
Company Representative or designee will provide the Institution and Investigator with the 
following safety information: 
• 
Refer to the Investigator’s Brochure for the determination of expectedness. 
o 
http://www.darzalex.com/shared/product/darzalex/darzalex-prescribing- 
information.pdf 
 
o 
For DARZALEX® (daratumumab),the expectedness of an adverse event will be 
determined by whether or not it is listed in the Investigator's Brochure. 

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• 
any new information, which becomes available during the course of the Study, which 
may affect the overall safety profile of the Janssen Product(s) Under Study. 
• 
ICF risk wording 
 
8.5.4.4 Company Safety Contact Information 
Contact details for the Company representative for submission of information required 
under this exhibit. 
 
Phone: contact the study assigned Janssen Trial Manager  
 
 
 
8.5.5 
Reporting of Pregnancy 
If a subject becomes pregnant during the study, in addition to reporting the pregnancy 
within 3 business days, a determination regarding Janssen Product(s) Under Study 
discontinuation and subject discontinuation must be made by the investigator in alignment 
with the protocol inclusion/exclusion criteria and in consultation with the reference safety 
information. 
Because the effect of the Janssen Product(s) Under Study on sperm is unknown, 
pregnancies in partners of male subjects exposed to a Janssen Product(s) Under Study will 
be reported by the Investigator within 3 business days of their knowledge of the event 
using the Serious Adverse Event Form. Depending on local legislation this may require 
prior consent of the partner. 
 
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae 
in the infant will be required. 
8.6 
Halting Rules 

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Temporary suspension of enrollment may occur for the following reasons: 
 
- 
Significant delays in administration of daratumumab in the home 
due to logistical barriers. 
 
- 
Infusion related reaction that occurs in the home that cannot be 
adequately managed. 
 
- 
Recurrent lost medication. 
 
9 Study Oversight

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In addition to the PI’s responsibility for oversight, study oversight will be under the 
direction of the SKCC’s Data and Safety Monitoring Committee (DSMC). The SKCC 
DSMC operates in compliance with a Data and Safety Monitoring Plan (DSMP) that is 
approved by the NCI. 
 
10 Clinical Site Monitoring and Auditing 
Clinical site monitoring and auditing is conducted to ensure that the rights of human 
participants are protected, that the study is implemented in accordance with the protocol 
and/or other operating procedures, and that the quality and integrity of study data and 
data collection methods are maintained. Monitoring and auditing for this study will be 
performed in accordance with the SKCC’s Data and Safety Monitoring Plan (DSMP) 
developed by the SKCC Data and Safety Monitoring Committee (DSMC). The DSMP 
specifies the frequency of monitoring, monitoring procedures, the level of clinical site 
monitoring activities (e.g., the percentage of participant data to be reviewed), and the 
distribution of monitoring reports. Some monitoring activities may be performed 
remotely, while others will take place at the study site(s). Appropriate staff will conduct 
monitoring activities and provide reports of the findings and associated action items in 
accordance with the details described in the SKCC DSMP. 
 
11 Statistical Considerations 
11.1 Study Hypotheses 
The study hypothesis is that administration of daratumumab at home will improve 
patient satisfaction as compared administration of daratumumab in the infusion center. 
 
11.2 Analysis Plans 
For primary analysis, the SWT domain CTSQ scores after all cycles will be analyzed 
jointly in a linear mixed effects model with a random effect of patient and the fixed effect 
of the delivery mode (home vs. infusion center). Log or other transformation of CTSQ 
scores will be used, as appropriate, to satisfy the model assumptions, Possible time 
trends will be considered in the model and incorporated, if significant. The mean 
difference in CTSQ scores between home and infusion center will be computed with the 
corresponding 95% confidence interval and tested (null hypothesis of zero mean 
difference) using appropriate model-based contrast with alpha 0.05. 
 
The same approach will be used for the secondary analysis of other CTSQ domains, 
EORTC QLQ-30, COST survey, and OOCAT survey scores. 
 
The adherence at the home setting cycles will be analyzed in repeated measures 
logistic regression model with a random effect of patient and the fixed effect of the 
delivery mode (home vs. infusion center). The model will be used to compute the 
average rate of home setting adherence with the corresponding 95% confidence 
interval. 

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Secondary endpoints related to the barriers to home administration and exploratory 
endpoints related to the patient perceptions of home based anti-neoplastic therapy will 
summarized using descriptive statistics. 
 
 
11.3 Interim Analyses and Stopping Rules 
No interim analysis will occur. 
 
11.3.1 Safety Review 
N/A 
 
11.3.2 Efficacy Review 
N/A 
 
11.4 Sample Size Considerations 
 
The model-based contrast to be used for testing the primary null hypothesis is a generalization of 
the paired t-test to the case of more than one observation under each delivery mode (scores for 
4 cycles at infusion center and 4 cycles at home). The proposed sample size of 20 patients 
provides 80% power to detect the minimally important difference of 5.9 points (Usmani et al, 2020) 
for CTSQ SWT domain score using the two-sided paired t-test with alpha 0.05 and assuming that 
the standard deviation of within patient differences is at most 8.92. Based on between-patient 
standard deviation of 13.76 for CTSQ SWT domain scores reported in Trask et al (2008), the 
standard deviation of within patient differences will be 8.92 or lower if the correlation between 
repeated score from the same patient is 0.79 or higher. The actual power will be higher since 
multiple observations per each delivery mode will be utilized in the linear mixed effects model. 
 
 
11.4.1 Accrual Estimates 
We estimate to enroll 20 patients in 26 months or 0.77 patients per month. We plan to 
complete enrollment after 26 months. 
 
11.5 Exploratory Analysis 
We will perform descriptive analysis as described above. 
 
12 Source Documents and Access to Source Data/Documents 
Study staff will maintain appropriate medical and research records for this study, in 
compliance with ICH E6, and regulatory and institutional requirements for the protection 
of confidentiality of participant information. Study staff will permit authorized 
representatives of SKCC and regulatory agencies to examine (and when required by 

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applicable law, to copy) research records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety, progress and data validity. Quality Control 
and Quality Assurance 
 
13. Quality control and quality assurance of the data will follow the SOP that has been 
predetermined and agreed upon by the CRO at SKCC. 
 
14. Ethics/Protection of Human Participants 
14.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6. 
 
14.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant 
materials will be submitted to the IRB for review and approval. Approval of both the 
protocol and the consent form must be obtained before any participant is enrolled. Any 
amendment to the protocol will require review and approval by the IRB before the 
changes are implemented in the study. 
 
14.3 Informed Consent Process 
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Extensive 
discussion of risks and possible benefits of study participation will be provided to 
participants and their families, if applicable. A consent form describing in detail the study 
procedures and risks will be given to the participant. Consent forms will be IRB- 
approved, and the participant is required to read and review the document or have the 
document read to him or her. The investigator or designee will explain the research 
study to the participant and answer any questions that may arise. The participant will 
sign the informed consent document prior to any study-related assessments or 
procedures. Participants will be given the opportunity to discuss the study with their 
surrogates or think about it prior to agreeing to participate. They may withdraw consent 
at any time throughout the course of the study. A copy of the signed informed consent 
document will be given to participants for their records. The rights and welfare of the 
participants will be protected by emphasizing to them that the quality of their clinical 
care will not be adversely affected if they decline to participate in this study. The 
consent process will be documented in the clinical or research record. 
 
14.4 Exclusion of Women, Minorities, and Children (Special Populations) 

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Pediatric population will be excluded as multiple myeloma is not a disease that affects 
those under the age of 18. 
 
14.5 Participant Confidentiality 
Participant confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to any study information relating to participants. 
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. 
The study monitor or other authorized representatives of the sponsor may inspect all 
study documents and records required to be maintained by the investigator, including 
but not limited to, medical records (office, clinic, or hospital) for the study participants. 
The clinical study site will permit access to such records. 
14.6 Future Use of Stored Specimens and Other Identifiable Data 
Specimens will not be stored for future use. 
 
15 Data Handling and Record Keeping 
The investigators are responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents must be completed in a neat, 
legible manner to ensure accurate interpretation of data. The investigators will maintain 
adequate case histories of study participants, including accurate case report forms 
(CRFs), and source documentation. 
15.1 Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the investigator. All source documents and laboratory reports 
must be reviewed by the study team and data entry staff, who will ensure that they are 
accurate and complete. Unanticipated problems and adverse events must be reviewed 
by the investigator or designee. 
15.2 Data Capture Methods 
Data will be captured through RedCAP database. The data will be collection on an 
ongoing process. 
 
REDCap is a secure, web-based platform designed for data capture and storage for research 
studies. The SKCC REDCap system is configured to be HIPAA compliant. The platform is 
housed on Jefferson IS&T managed servers and runs in two distinct environments: a webserver 
which allows access to the REDCap web application and a database server which houses data 
collected from all REDCap projects. The SKCC REDCap team keeps the REDCap software as 

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up to date as possible while conserving functionality of the platform and ensuring minimal 
interruptions. The REDCap database is backed up at regular intervals to a secondary location. 
 
 
REDCap tracks all user activity to system logs which are available to project owners and other 
roles with the requisite permissions to view this information. Additional logging is available to 
the system administrators but is not routinely distributed without a significant reason for doing 
so. The REDCap systems are routinely scanned by Jefferson IS&T for potential problems and 
vulnerabilities. Any significant issues identified are remediated immediately. 
 
 
Users are able to access the SKCC REDCap instance with a valid Jefferson campus key and 
password after agreeing to the terms and conditions for use. The REDCap support team 
automatically suspends users with long periods of inactivity for security reasons. At a project 
level, project owners are responsible for who has access to each project, as well as the level of 
access and permissions given to each project user. REDCap administrators will only over-ride 
this access in special circumstances and only with requisite approval. 
 
 
15.3 Types of Data 
Data that will be collected include laboratory data, medical history data, questionnaires, 
and logistical data. 
 
Content reports will be performed quarterly. 
 
15.4 Study Records Retention 
Study records will be maintained for at least three years from the date that the grant 
federal financial report (FFR) is submitted to the NIH. 
Study documents must be retained for a minimum of 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period, however, if required by local regulations. 
No records will be destroyed without the written consent of the sponsor, if applicable. It 
is the responsibility of the sponsor to inform the investigator when these documents no 
longer need to be retained. 
15.5 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical 
Practice, or Manual of Procedures requirements. The noncompliance may be on the 
part of the participant, the investigator, or study staff. As a result of deviations, 
corrective actions are to be developed by the study staff and implemented promptly. 

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All deviations from the protocol must be addressed in study participant source 
documents and promptly reported to the IRB and other regulatory bodies according to 
their requirements. 
 
16 Study Finances 
16.1 Funding Source 
The study is financed through Janssen IIT funding mechanism. 
 
16.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the conflict 
reviewed by a properly constituted Conflict of Interest Committee with a Committee-sanctioned 
conflict management plan that has been reviewed and approved by the study sponsor prior to 
participation in this study. All Jefferson University Investigators will follow the TJU Conflicts of 
Interest Policy for Employees (107.03). 
16.3 Participant Stipends or Payments 
There will be compensation for study participation. Subjects will be awarded $50 per in 
clinic visit (a total of 6 visits). There will be no payment for at home infusions. 
 
17 Publication and Data Sharing Policy 
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication. 
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a clinical trials registration policy as a condition for publication. The ICMJE 
defines a clinical trial as any research project that prospectively assigns human 
participants to intervention or concurrent comparison or control groups to study the 
cause-and-effect relationship between a medical intervention and a health outcome. 
Medical interventions include drugs, surgical procedures, devices, behavioral 
treatments, process-of-care changes, and the like. Health outcomes include any 
biomedical or health-related measures obtained in patients or participants, including 
pharmacokinetic measures and adverse events. The ICMJE policy requires that all 
clinical trials be registered in a public trials registry such as ClinicalTrials.gov, which is 
sponsored by the National Library of Medicine. Other biomedical journals are 
considering adopting similar policies. The ICMJE does not review specific studies to 
determine whether registration is necessary; instead, the committee recommends that 
researchers who have questions about the need to register err on the side of 
registration or consult the editorial office of the journal in which they wish to publish. 

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U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or 
FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or 
designated principal investigator) register and report results of certain "applicable 
clinical trials:" 
Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I 
investigations, of a product subject to FDA regulation; 
Trials of Devices: Controlled trials with health outcomes of a product subject to FDA 
regulation (other than small feasibility studies) and pediatric postmarket surveillance 
studies. 
NIH grantees must take specific steps to ensure compliance with NIH implementation of 
FDAAA. 
 
18 Literature References 
1. 
Rajkumar, S.V., Multiple myeloma: Every year a new standard? Hematological 
Oncology, 2019. 37(S1): p. 62-65. 
2. 
Palumbo, A., et al., Continuous Therapy Versus Fixed Duration of Therapy in Patients 
With Newly Diagnosed Multiple Myeloma. Journal of Clinical Oncology, 2015. 33(30): p. 
3459-3466. 
3. 
Roy, A., et al., Estimating the Costs of Therapy in Patients with Relapsed and/or 
Refractory Multiple Myeloma: A Model Framework. American health & drug benefits, 
2015. 8(4): p. 204-215. 
4. 
Fonseca, R. and J. Hinkel, Value and Cost of Myeloma Therapy—We Can Afford It. 
American Society of Clinical Oncology Educational Book, 2018(38): p. 647-655. 
5. 
Rajkumar, S.V., Value and Cost of Myeloma Therapy. American Society of Clinical 
Oncology Educational Book, 2018(38): p. 662-666. 
6. 
Huntington, S.F., et al., Financial toxicity in insured patients with multiple myeloma: a 
cross-sectional pilot study. Lancet Haematol, 2015. 2(10): p. e408-16. 
7. 
Wang, B., et al., A tertiary center experience of multiple myeloma patients with COVID- 
19: lessons learned and the path forward. Journal of Hematology & Oncology, 2020. 
13(1): p. 94. 
8. 
Hematology, A.S.o., COVID-19 and Multiple Myeloma. Version 1.2; last updated July 21, 
2020. 
9. 
Durie, B.G.M., et al., Longer term follow-up of the randomized phase III trial SWOG 
S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and 
dexamethasone in patients (Pts) with previously untreated multiple myeloma without an 
intent for immediate autologous stem cell transplant (ASCT). Blood Cancer Journal, 
2020. 10(5): p. 53. 
10. 
Mateos, M.-V., et al., Daratumumab plus Bortezomib, Melphalan, and Prednisone for 
Untreated Myeloma. New England Journal of Medicine, 2017. 378(6): p. 518-528. 
11. 
Facon, T., et al., Daratumumab plus Lenalidomide and Dexamethasone for Untreated 
Myeloma. New England Journal of Medicine, 2019. 380(22): p. 2104-2115. 
12. 
Evans, J.M., et al., A multi-method review of home-based chemotherapy. European 
Journal of Cancer Care, 2016. 25(5): p. 883-902. 
13. 
Directors, A.B.o., American Society of Clinical Oncology Position Statement 
Home Infusion of Anticancer Therapy. 2020. 

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SUPPLEMENTAL MATERIALS 
 
These documents are relevant to the protocol, but they are not considered part of the 
protocol. They are stored and modified separately. As such, modifications to these 
documents do not require protocol amendments. 
 
Appendix A: Schedule of Events 

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Appendices 
 
Appendix A: Schedule of Events 
 
Events Schedule: Patients already on Monthly Daratumumab 
 
Schedule of events 
For patients 
transitioning from 
IV to Subcutaneous 
therapy 
Events 
Screening 
Infusion 
Center 
Home 
Infusion 
Infusion 
Center 
End of 
Study 
Assessme 
nt 
Notes 
Day -30 to 
0 
C1D1 
(+/-3 days) 
C2D1 
(+/-3 days) 
C3D1 
(+/-3 
days) 
C4D1 
(+/-3 
days) 
C5D1 
(+/-3 
days) 
C6D1 
(+/-3 
days) 
C7D1 (+/- 
3 days) 
C8D1 
(+/-3 
days) 
No later 
than 45 
days after 
last 
treatment 
cycle 
Administrative 
Procedures 
Informed consent 
X 
Inclusion/exclusion 
criteria 
X 
General medical 
history 
X 
Prior/Concomitant 
Medications 
X 
ECG 
X 
Current Myeloma 
Disease status 
X 
Schedule of events 
For patients 
transitioning from 
IV to Subcutaneous 
therapy 
Events 
Screening 
Infusion 
Center 
Home 
Infusion 
Infusion 
Center 
End of 
Study 
Assessme 
nt 
Notes 

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Day -30 to 
0 
C1D1 
(+/-3 days) 
C2D1 
(+/-3 days) 
C3D1 
(+/-3 
days) 
C4D1 
(+/-3 
days) 
C5D1 
(+/-3 
days) 
C6D1 
(+/-3 
days) 
C7D1 (+/- 
3 days) 
C8D1 
(+/-3 
days) 
No later 
than 45 
days after 
last 
treatment 
cycle 
Pregnancy Test 
(WOCBP) 
X 
CBC 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CMP 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serum Protein 
Electropheresis 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serum Free Light 
Chains 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serum 
Immunoglobulins 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hepatitis B (HBV) 
serology 
X 
If not 
previou 
sly 
tested, 
local 
testing 
for 
hepatiti 
s B 
surface 
antigen 
(HBsAg 
), 
hepatiti 
s B 
surface 
antibod 
y (Anti- 
HBs), 
and 
hepatiti 
s B 
core 
antibod 
y (Anti- 
HBc) 
should 
be sent. 
Schedule of events 
For patients 
transitioning from 
IV to Subcutaneous 
therapy 
Events 
Screening 
Infusion 
Center 
Home 
Infusion 
Infusion 
Center 
End of 
Study 
Assessme 
nt 
Notes 

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Day -30 to 
0 
C1D1 
(+/-3 days) 
C2D1 
(+/-3 days) 
C3D1 
(+/-3 
days) 
C4D1 
(+/-3 
days) 
C5D1 
(+/-3 
days) 
C6D1 
(+/-3 
days) 
C7D1 (+/- 
3 days) 
C8D1 
(+/-3 
days) 
No later 
than 45 
days after 
last 
treatment 
cycle 
HBV DNA testing 
X 
For 
subject 
s with 
serologi 
c 
evidenc 
e of 
resolve 
d HBV 
infectio 
n (i.e., 
positive 
Anti- 
HBs or 
positive 
Anti- 
HBc) at 
Screeni 
ng, 
HBV 
DNA 
testing 
by PCR 
must be 
perform 
ed 
locally. 
Survey 
Assessments 
Treatment Burden 
Questionnaire 
X 
X 
X 
X 
X 
X 
X 
X 
COST Survey 
X 
X 
X 
X 
X 
X 
X 
X 
E-PRO survey tool 
X 
X 
X 
X 
X 
X 
X 
X 
Opportunity cost 
survey 
X 
X 
X 
X 
X 
X 
X 
X 
Safety 
Assessments 
AE assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Schedule of events 
For patients 
transitioning from 
IV to Subcutaneous 
therapy 
Events 
Screening 
Infusion 
Center 
Home 
Infusion 
Infusion 
Center 
End of 
Study 
Assessme 
nt 
Notes 

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Day -30 to 
0 
C1D1 
(+/-3 days) 
C2D1 
(+/-3 days) 
C3D1 
(+/-3 
days) 
C4D1 
(+/-3 
days) 
C5D1 
(+/-3 
days) 
C6D1 
(+/-3 
days) 
C7D1 (+/- 
3 days) 
C8D1 
(+/-3 
days) 
No later 
than 45 
days after 
last 
treatment 
cycle 
Physical Exam (can 
be virtual exam) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECOG assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Barriers 
Assessment 
Delay in treatment 
X 
X 
X 
X 
Delay in 
medication delivery 
to home 
X 
X 
X 
X 
Delay in nurse 
arrival 
X 
X 
X 
X 
Wasted drug 
X 
X 
X 
X 
Issues with 
storage/disposal of 
drug 
X 
X 
X 
X 
Other supply chain 
issues 
X 
X 
X 
X 
Patient Interview 
X