Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma
Phase: PHASE2
Conditions: Multiple Myeloma in Relapse
Sponsor: University of Colorado, Denver

 
Physician Selected Selinexor-based Therapy for Relapsed/Refractory Multiple 
Myeloma 
 
PI: Daniel Sherbenou 
 
NCT044925193 
 
January 02, 2025 

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 1 of 105 
Confidential 
Clinical Study Protocol 
Physician Selected Selinexor-based Therapy for 
Relapsed/Refractory Multiple Myeloma 
Study Number: 
20-2202 
Study Phase: 
2 
Product Name(s): 
Selinexor (KPT-330) 
IND or EudraCT 
Number: 
154562  
IST Identifier: 
336 
Indication: 
Relapsed/Refractory Multiple Myeloma 
Sponsor: 
University of Colorado, Anschutz Medical Campus 
Sponsor-
Investigator: 
Daniel Sherbenou, MD PhD 
University of Colorado 
1665 Aurora Court 
Aurora, CO 80045 
 
Selinexor 
Supplier/Drug 
Supplier and 
Funding Source: 
Karyopharm Therapeutics, Inc.  
Newton, MA 02459 USA 
Protocol Version 
and Date: 
V5, 02JAN2025 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 2 of 105 
Confidential 
INVESTIGATORS' AGREEMENT 
STATEMENT OF COMPLIANCE 
This is an investigator-initiated study.  The principal investigator (PI), Daniel Sherbenou, MD 
PhD, is conducting the study and the University of Colorado is acting as the sponsor.  As the 
sponsor-investigator, both the legal/ethical obligations of a PI and those of a sponsor will be 
followed. 
The trial will be carried out in accordance with Good Clinical Practice (GCP) as required by 
applicable United States (US) laws and applications, including but not limited to United States 
(US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR 
Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
In accordance with 21 CFR 25.30/25.31, this protocol qualifies for a categorical exclusion from 
the requirement for an environmental assessment for the manufacture and formulation for use in 
human clinical trials. All waste from the investigational drug(s) will be properly controlled. The 
amount of waste expected to enter the environment may reasonably be expected to be nontoxic. 
To the Sponsor-Investigator’s knowledge, no extraordinary circumstances exist. 
The PI will assure that no changes to the protocol will take place without documented approval 
from the Institutional Review Board (IRB). All personnel involved in the conduct of this study 
have completed Human Subjects Protection Training.  
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments. 
 
Sponsor-Investigator Signature: 
 
 
Investigator’s Name: 
Daniel Sherbenou, MD PhD 
Institution: 
University of Colorado 
Date: 
 
 
 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E
February 5, 2025 | 5:11:53 PM MST

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 3 of 105 
Confidential 
TABLE OF CONTENTS 
TABLE OF CONTENTS ...........................................................................................................3 
SCHEDULE OF ASSESSMENTS LIST ..................................................................................7 
FIGURES LIST .........................................................................................................................7 
ABBREVIATIONS AND DEFINITIONS OF TERMS LIST ..................................................8 
1 
PROTOCOL SYNOPSIS ................................................................................................11 
2 
SCHEDULE OF ASSESSMENTS AND STUDY SCHEMATICS ...............................16 
3 
INTRODUCTION ...........................................................................................................29 
3.1 
Multiple Myeloma .................................................................................................29 
3.2 
Selinexor ................................................................................................................29 
3.2.1 
Selinexor Mechanism of Action ..................................................................30 
3.2.2 
Selinexor Nonclinical Studies ......................................................................30 
3.2.3 
Overall Clinical Experience with Selinexor ................................................30 
 
Pharmacokinetics ...............................................................................30 
 
Safety and Efficacy ............................................................................31 
3.2.4 
Treatments That Will Be Used in Combination with Selinexor ..................31 
 
Pomalidomide (Pomalyst®) ...............................................................31 
 
Daratumumab .....................................................................................32 
 
Carfilzomib ........................................................................................33 
3.2.5 
Myeloma Drug Sensitivity Testing ..............................................................34 
3.3 
Study and Dose Rationale ......................................................................................34 
3.3.1 
Rationale for the Study and the Study Design .............................................34 
3.3.2 
Dose Schedule Rationale .............................................................................35 
 
Selinexor Dosing ................................................................................35 
 
Pomalidomide Dosing ........................................................................35 
 
Daratumumab Dosing ........................................................................35 
 
Carfilzomib Dosing ............................................................................35 
3.3.3 
Benefit/Risk Assessment .............................................................................36 
4 
STUDY OBJECTIVES ....................................................................................................37 
5 
STUDY DESIGN.............................................................................................................38 
6 
STUDY POPULATION ..................................................................................................38 
6.1 
Study Population ....................................................................................................38 
6.2 
Inclusion Criteria ...................................................................................................38 
6.3 
Exclusion Criteria ..................................................................................................39 
7 
STUDY TREATMENTS AND TREATMENT ASSIGNMENT ...................................40 
7.1 
Treatments Administered .......................................................................................40 
7.1.1 
Study Treatments .........................................................................................40 
7.2 
Study Treatment Labeling and Storage..................................................................41 
7.2.1 
Labeling .......................................................................................................41 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
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7.2.2 
Storage .........................................................................................................41 
7.3 
Study Treatment Dosing and Administration ........................................................41 
7.3.1 
Dispensing Directions ..................................................................................41 
7.3.2 
Dosing Information ......................................................................................41 
 
Selinexor ............................................................................................41 
 
Pomalidomide, Carfilzomib and Daratumumab ................................41 
7.3.3 
Dose Sequence and Timing for Combination Treatments ...........................42 
7.4 
Method of Assigning Patients to Treatment Groups..............................................42 
7.5 
Blinding..................................................................................................................42 
7.6 
Dose Schedules for Evaluation ..............................................................................42 
7.6.1 
Selinexor/Pomalidomide/Dexamethasone Arm (1) .....................................42 
7.6.2 
Selinexor/Daratumumab/Dexamethasone Arm (2)......................................42 
7.6.3 
Selinexor/Carfilzomib/Dexamethasone Arm (3) .........................................42 
7.7 
Missed or Vomited Doses ......................................................................................43 
7.7.1 
Missed Doses of Selinexor...........................................................................43 
7.7.2 
Vomited Doses of Selinexor ........................................................................43 
7.8 
Dose Modifications ................................................................................................43 
7.8.1 
Selinexor Dose Reduction Guidelines .........................................................43 
 
Selinexor Dose Adjustment in the Setting of Infection .....................46 
 
Conditions Not Requiring Selinexor Dose Reduction .......................46 
7.8.2 
Dose Modifications for Overlapping Toxicities ..........................................46 
 
Thrombocytopenia .............................................................................47 
 
Neutropenia ........................................................................................47 
7.8.3 
Carfilzomib Dose Modifications..................................................................47 
7.8.4 
Pomalidomide Dose Modifications..............................................................49 
7.9 
Duration of Treatment and Follow-up ...................................................................49 
7.10 
Supportive Care, Contraception Requirements, Concomitant Medications, and 
Restrictions ............................................................................................................49 
7.10.1 
Required Anti-emetic Support .....................................................................49 
7.10.2 
Recommended Supportive Care for All Patients .........................................49 
7.10.3 
Contraception Requirements ........................................................................50 
7.10.4 
Concomitant Medication and Treatment .....................................................50 
7.10.5 
Permitted Concomitant Medication .............................................................50 
7.10.6 
Prohibited Medications ................................................................................50 
7.10.7 
Restrictions for Study Treatment .................................................................51 
 
Restrictions for Selinexor ..................................................................51 
 
Restrictions for pomalidomide, daratumumab and carfilzomib ........51 
8 
STUDY ASSESSMENTS ...............................................................................................52 
8.1 
Informed Consent...................................................................................................52 
8.2 
Demographic and Baseline Characteristics Assessments ......................................52 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
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8.2.1 
Demographics ..............................................................................................52 
8.2.2 
Medical History ...........................................................................................52 
8.3 
Efficacy Assessments.............................................................................................52 
8.3.1 
Multiple Myeloma Disease Assessments .....................................................52 
Table 7  
Multiple Myeloma Disease-Specific Assessments ......................................53 
8.4 
Safety Assessments ................................................................................................54 
8.4.1 
Adverse Events ............................................................................................54 
8.4.2 
Concomitant Medications ............................................................................54 
 
Medications Administered During Hospitalizations ..........................54 
8.4.3 
Clinical Safety Assessments ........................................................................54 
 
Weight, Height, and BSA ..................................................................54 
 
Physical Examination, Vital Signs, and ECOG Performance Status .54 
8.4.4 
Electrocardiography .....................................................................................55 
8.4.5 
Laboratory Safety Assessments ...................................................................55 
 
Clinical Laboratory Tests ...................................................................55 
 
Pregnancy Testing ..............................................................................56 
8.5 
Other Assessments .................................................................................................56 
8.5.1 
Nutritional Consultation...............................................................................56 
8.5.2 
Subject Contact ............................................................................................56 
8.5.3 
Durability of Response and Survival Follow-up Visit(s) ............................56 
9 
SAFETY DEFINITIONS, RECORDING, AND REPORTING .....................................57 
9.1 
Adverse Events ......................................................................................................57 
9.1.1 
Definitions....................................................................................................57 
9.1.2 
Recording of Adverse Events ......................................................................58 
 
Laboratory Test Abnormalities ..........................................................59 
9.1.3 
Adverse Event Severity................................................................................59 
9.1.4 
Adverse Event Causality ..............................................................................59 
9.2 
Serious Adverse Events .........................................................................................60 
9.2.1 
Recording of Serious Adverse Events .........................................................60 
9.2.2 
Reporting of Serious Adverse Events ..........................................................60 
9.2.3 
Suspected Unexpected Serious Adverse Reactions .....................................61 
9.2.4 
Adverse Event Reporting .............................................................................62 
9.3 
Procedures for Handling Special Situations ..........................................................62 
9.3.1 
Pregnancy and Breastfeeding .......................................................................62 
10 DISCONTINUATION CRITERIA .................................................................................63 
10.1 
Early Study Termination, Study Treatment Discontinuation, and Patient 
Withdrawal Criteria ...............................................................................................63 
10.2 
Early Termination of the Study ..............................................................................63 
10.3 
Discontinuation of Study Treatment and/or Withdrawal of Patients from the Study64 
11 STUDY VISITS ...............................................................................................................65 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
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11.1 
Description of Study Days .....................................................................................65 
11.1.1 
Screening......................................................................................................65 
11.1.2 
Cycle 1 .........................................................................................................66 
 
Study Procedures (Days 1-28) ...........................................................66 
 
Study Treatment Dosing ....................................................................66 
 
Cycle 1 Day 3 (+1 day) Contact ........................................................66 
11.1.3 
Cycles ≥2 .....................................................................................................67 
 
Study Procedures ...............................................................................67 
 
Study Treatment Dosing ....................................................................67 
11.1.4 
End-of-Treatment Visit (≥30 Days after Last Dose) ...................................68 
11.1.5 
Survival Follow-Up .....................................................................................68 
12 PLANNED STATISTICAL METHODS ........................................................................68 
12.1 
General Considerations ..........................................................................................68 
12.2 
Determination of Sample Size ...............................................................................69 
12.3 
Analysis Populations ..............................................................................................69 
12.3.1 
Safety Population .........................................................................................69 
12.4 
Demographics and Baseline Characteristics ..........................................................69 
12.5 
Efficacy Analysis ...................................................................................................69 
12.6 
Safety Analysis ......................................................................................................70 
12.6.1 
Adverse Events ............................................................................................70 
12.6.2 
Laboratory Data ...........................................................................................70 
12.6.3 
Vital Signs and Physical Examinations .......................................................71 
13 ADMINISTRATIVE MATTERS ....................................................................................71 
13.1 
Regulatory and Ethical Compliance ......................................................................71 
13.2 
Ethics Committees .................................................................................................71 
13.3 
Regulatory Authority Approval .............................................................................71 
13.4 
Protocol Adherence ................................................................................................71 
13.5 
Amendments to the Protocol ..................................................................................72 
13.6 
Informed Consent...................................................................................................72 
13.7 
Patient Confidentiality and Disclosure ..................................................................72 
13.8 
Collection, Auditing Study Documentation, and Data Storage .............................72 
13.8.1 
Study Documentations, Record Keeping and Retention of Documents ......72 
13.8.2 
Monitoring and Oversight ............................................................................73 
13.8.3 
Clinical Monitoring, Audit Procedures ........................................................74 
13.9 
Termination of the Study .......................................................................................74 
14 REFERENCE LIST .........................................................................................................75 
 
SERIOUS ADVERSE EVENT REPORT FORM .......................................79 
 
TEMPLATE FOR LINE LISTING OF ADVERSE EVENTS ...................80 
 
MEMO REGARDING CROSS-REPORTED SUSARS FROM KPT CSTS81 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
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EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE 
STATUS CRITERIA .......................................................................................................82 
 
INTERNATIONAL MYELOMA WORKING GROUP RESPONSE 
CRITERIA, MYELOMA ................................................................................................83 
 
SCHEDULE OF ASSESSMENTS LIST 
Table 1 
Schedule of Study Activities and Assessments – ARM 1(SPd) ................16 
Table 2 
Schedule of Study Activities and Assessments – ARM 2(SDd)................20 
Table 3 
Schedule of Study Activities and Assessments – ARM 3 (SKd)...............24 
 
FIGURES LIST 
Figure 1 
 Study Flow Chart ......................................................................................28 
 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
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ABBREVIATIONS AND DEFINITIONS OF TERMS LIST 
Abbreviation 
Definition 
AE 
adverse event 
ALT 
alanine transaminase (SGPT) 
ANC 
absolute neutrophil count 
aPTT 
activated partial thromboplastin time 
AST 
aspartate transaminase (SGOT) 
AUClast 
area under the curve, first-last measurement 
AUC(0-∞) 
area under the curve, time zero to last 
BIW 
twice weekly 
BP 
blood pressure 
BSA 
body surface area 
BSC 
best supportive care 
BUN 
blood urea nitrogen 
C 
degrees Celsius 
CBC 
complete blood count 
CBR 
clinical benefit response rate 
CFR 
Code of Federal Regulations 
CHF 
congestive heart failure 
CI 
confidence Interval 
cm 
centimeter 
Cmax 
maximum serum concentration 
CNS 
central nervous system 
CR 
complete remission 
CRA 
clinical research associate 
CrCl 
creatinine clearance 
CRM1 
chromosomal region maintenance protein 1 
CSF 
cerebrospinal fluid 
CSR 
clinical study report 
CST 
Company-Sponsored Trial 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTEP 
Cancer Therapy Evaluation Program 
DCR 
disease control rate (CR, PR, SD ≥ 4 weeks) 
Dex 
dexamethasone 
DLT 
dose limiting toxicity 
DNA 
deoxyribonucleic acid 
DOR 
duration of response 
DSMC 
Data Safety Monitoring Committee 
EC 
ethics committee 
ECG 
electrocardiogram 
eDC 
electronic data capture 
ECOG 
Eastern Cooperative Oncology Group 
EDTA 
ethylenediaminetetraacetic acid 
F% 
oral bioavailability 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
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Abbreviation 
Definition 
F 
degrees Fahrenheit 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
G-CSF 
granulocyte-colony stimulating factor 
GGT 
gamma-glutamyl transferase 
GI 
gastrointestinal 
GRP 
growth regulatory protein 
GSH 
glutathione 
Hb 
hemoglobin 
HBsAg 
hepatitis B virus surface antigen 
HBV 
hepatitis B virus 
hCG 
human chorionic gonadotropin 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
hr 
Hour 
IC50 
inhibitory concentration, 50% (half maximal inhibitory concentration) 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
eIF4E 
mRNA cap-binding protein eukaryotic translation factor 4E 
IL 
interleukin  
IMiD 
immunomodulatory drug 
IMWG 
International Myeloma Working Group 
INR 
international normalization ratio 
IPI 
International Prognostic Index 
IR 
intermediate risk 
IRB 
Institutional Review Board 
ISS 
International Staging System 
IST 
Investigator-Sponsored Trial 
IV 
intravenous 
kg 
Kilogram 
KM 
Kaplan-Meier 
LDH 
lactic dehydrogenase 
m2 
square meters 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
MI 
myocardial infarction 
min 
Minute 
miRNA 
microRNA 
mL 
Milliliter 
mITT 
modified Intent-to-Treat 
MM 
multiple myeloma 
mmHg 
millimeters of mercury 
MTD 
maximum tolerated dose 
MR 
minor response 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
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Abbreviation 
Definition 
mRNA 
messenger ribonucleic acid 
MUGA 
multiple gated acquisition 
My-DST 
Myeloma drug sensitivity testing 
NAC 
N-acetylcysteine 
NCCN 
National Comprehensive Cancer Network 
NCI 
National Cancer Institute 
NES 
nuclear export sequences 
NK1R 
neurokinin 1 receptor 
NPC 
nuclear pore complex 
ORR 
overall response rate (sCR + CR + VGPR + PR) 
OS 
overall survival 
PCR 
polymerase chain reaction 
PD 
progressive disease 
PDn 
pharmacodynamics 
PE 
physical examination 
PFS 
progression free survival 
PI 
proteasome inhibitor  
PK 
pharmacokinetic 
PR 
partial response 
PT 
prothrombin time 
PTT 
partial thromboplastin time 
QD 
once daily 
QW 
once weekly 
RBC 
red blood cell 
RNA 
ribonucleic acid 
RR 
Relapsed/Refractory 
SAE 
serious adverse event 
SAM 
S-adenosylmethionine 
SC 
subcutaneous 
sCR 
stringent complete response 
SD  
stable disease 
SINE 
selective inhibitor of nuclear export 
SOC  
standard of care 
SOP 
standard operating procedure 
STD 
standard deviation 
TEAE 
treatment-emergent adverse event 
Tmax 
time to maximum serum concentration 
TRAE 
treatment-related adverse event 
TSP 
tumor suppressor protein 
TTP 
time to progression 
ULN 
upper limit of normal 
VGPR 
very good partial response 
WBC 
white blood cell 
XPO1 
exportin 1 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
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1 
PROTOCOL SYNOPSIS 
Sponsor-Investigator/Institution: 
University of Colorado, Anschutz 
Medical Campus 
Investigational Product (s): 
Selinexor (KPT-330) 
 
Developmental Phase: 
2 
Title of Study: Physician Selected Selinexor based Therapy for relapsed/refractory Multiple Myeloma 
Protocol Number: 20-2202 
IST Identifier: 336 
Indication: Relapsed and refractory multiple myeloma 
Study Rationale: Given its unique mechanism of action, selinexor (KPT-330, Xpovio) presents an 
attractive partner for commonly used therapeutic agents in relapsed/refractory multiple myeloma 
(RRMM).  The ongoing phase Ib/II STOMP trial is evaluating selinexor as part of several multidrug 
regimens incorporating the most active currently available myeloma therapeutics.  The STOMP trial 
includes dose finding and expansion cohorts to describe initial efficacy and safety for selinexor and 
dexamethasone in combination with the proteasome inhibitor carfilzomib, the immunomodulatory 
agent pomalidomide and the CD-38 targeting monoclonal antibody daratumumab, amongst other 
combinations.  However, as with other therapeutic choices in the RRMM setting the decision for 
which of these partners to utilize with selinexor therapy is largely empiric. This trial will seek to 
evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician’s 
choice and compared prospectively to ex vivo drug sensitivity testing results. 
 
 
Objectives and Endpoints: 
 
Objectives 
Endpoints 
Primary 
 To evaluate the overall response rate 
achieved with physician’s choice 
selinexor-based combination therapy 
ORR by IMWG criteria (based on Kumar et 
al 2016) [appendix 5] 
Secondary 
 To evaluate the minimal residual 
disease negative response rate 
achieved with physician’s choice 
selinexor-based combination therapy 
 To evaluate the duration of disease 
control and survival for patients 
treated with physician’s choice 
selinexor-based combination therapy 
MRD negative response rate assessed via 
NGS or multiparametric flow cytometry 
with sensitivity of 10-5 
  
 
PFS, DOR, OS, TTNT 
 
 
Occurrence, nature and severity of 
Adverse Events  
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
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Sponsor-Investigator/Institution: 
University of Colorado, Anschutz 
Medical Campus 
Investigational Product (s): 
Selinexor (KPT-330) 
 
Developmental Phase: 
2 
 To evaluate safety and tolerability of 
selinexor in combination with partner 
backbone agents 
 
Exploratory 
 Feasibility of My-DST testing to 
inform treatment choice  
 Evaluation of My-DST related 
predictors of response 
Rate of assay failure; Rate of 
identification of preferred partner therapy 
or combination 
ORR in patients with concordance or 
discordance between MyDST results and 
physicians selected regimen 
Overall Study Design: 
This study will be a single institution, open-label phase II study to evaluate the overall response rate 
achieved with selinexor and dexamethasone based three drug combination therapy, selected by 
physician’s choice, in patients with relapsed/refractory multiple myeloma. 
Patients with RRMM will be eligible for enrollment. During screening, in addition to standard of 
care disease assessments, participant’s bone marrow aspirate will be evaluated using a novel ex vivo 
Myeloma Drug Sensitivity Testing platform (My-DST). The following agents will be eligible for 
physician’s choice, and in parallel evaluated for sample sensitivity in MyDST:  pomalidomide, 
carfilzomib and daratumumab. Agents will be tested individually, in combination with selinexor and 
in combination with selinexor and dexamethasone. Results from MyDST will be not be available to 
investigators at time of treatment assignment, results from this test will be evaluated as part of 
exploratory analyses to better characterize test performance and relationship with treatment 
outcomes.  
Investigators will assign patients to one of the following treatment combinations: 
Selinexor/Pomalidomide/Dexamethsone (SPd), Selinexor/Daratumumab/Dexamethasone (SDd) or 
Selinexor/Carfilzomib/Dexamethasone (SKd). Investigators will use  patient specific considerations 
such as prior therapeutic exposures, response to / tolerance of prior therapies and comorbid 
conditions which may increase risk for toxicity with specific agents to guide expert judgement in 
selecting partner agent for selinexor and dexamethasone. Treatment will continue until progression 
of disease, unacceptable toxicity or death. 
This study will evaluate if physician’s choice partner drug selection for selinexor based combination 
therapy in RRMM will lead to an overall response rate of 75% or higher.   
Oversight will be provided by the Data and Safety Monitoring Committee (DMSC) at the University of 
Colorado Cancer Center 
Number of Patients (planned): 18 
Study Population:  Relapsed and refractory multiple myeloma 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 13 of 105 
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Sponsor-Investigator/Institution: 
University of Colorado, Anschutz 
Medical Campus 
Investigational Product (s): 
Selinexor (KPT-330) 
 
Developmental Phase: 
2 
Inclusion Criteria: 
Patients must meet all of the following inclusion criteria to be eligible to enroll in this study: 
1. Age ≥ 18 years 
2. Willing and able to provide written informed consent in accordance with federal, local, and 
institutional guidelines. The patient must provide informed consent prior to the first screening 
procedure. 
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2  
4. Histologically confirmed diagnosis, measurable disease and evidence of disease progression of 
MM after 1 or more prior lines of therapy with either of the following: 
a. Documented evidence of PD after achieving at least SD for ≥ 1 cycle during a 
previous MM regimen (i.e., relapsed MM) 
b. ≤ 25% response (i.e, patient never achieved ≥ MR) or PD during or within 60 days 
from end of the most recent MM regimen (i.e., refractory MM) 
5. Patients must have measurable disease as defined by at least one of the 
following: 
a. Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or, for IgA 
myeloma, by quantitative IgA 
b. Urinary M-protein excretion at least 200 mg/24 hours 
c. Serum FLC ≥ 10 mg/dL, provided that FLC ratio is abnormal 
d. If no measurable disease by serum or urine, then the presence of a plasmacytoma of 
≥2cm in one dimension prior to start of study can be used to follow response via 
radiologic imaging.  
6. Adequate hepatic function: 
a. Total bilirubin < 1.5 × upper limit of normal (ULN) (except patients with Gilbert’s 
syndrome who must have a total bilirubin of < 3 × ULN), and 
b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to <2.5 
× ULN. 
7. Adequate renal function as determined by serum creatinine of ≤2 mg/dL OR estimated 
creatinine clearance of ≥ 20 mL/min, calculated using the Cockcroft and Gault formula (140 
– Age) • Mass (kg)/ (72 • creatinine mg/dL); multiply by 0.85 if female (Cockcroft 1976). 
8. Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count 
≥1000/mm3, hemoglobin ≥8 g/dL and platelet count ≥100,000/mm3 (patients for whom <50% 
of bone marrow nucleated cells are plasma cells) or ≥50,000/mm3 (patients for whom ≥50% 
of bone marrow nucleated cells are plasma cells). 
a. Patients may receive hematopoietic growth factor support, including erythropoietin, 
darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte 
macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, 
eltrombopag, romiplostim, or interleukin-11) at any time. 
b. Patients may receive RBC and/or platelet transfusions as clinically indicated per 
institutional guidelines during the study. 
9. Female patients of childbearing potential must have a negative serum pregnancy test at 
Screening. Female patients of childbearing potential and fertile male patients who are 
sexually active with a female of childbearing potential must use highly effective methods of 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 14 of 105 
Confidential 
Sponsor-Investigator/Institution: 
University of Colorado, Anschutz 
Medical Campus 
Investigational Product (s): 
Selinexor (KPT-330) 
 
Developmental Phase: 
2 
contraception throughout the study and for 3 months following the last dose of protocol 
required therapies. 
 
Exclusion Criteria: 
Patients meeting any of the following exclusion criteria are not eligible to enroll in this study: 
1. Has received selinexor or another SINE (Specific Inhibitor of Nuclear Export) compound in a 
previous line of therapy.  
2. Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, 
uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study 
procedures. 
3. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 
1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled 
infection within 1 week prior to C1D1 are acceptable.  
4. Known intolerance, hypersensitivity, or contraindication to study drugs. 
5. Pregnant or breastfeeding females. 
6. Major surgery within 4 weeks prior to C1D1. 
7. Active, unstable cardiovascular function, as indicated by the presence of: 
a. Symptomatic ischemia, or  
b. Uncontrolled clinically significant conduction abnormalities (eg, patients with 
ventricular tachycardia on anti-arrhythmics are excluded; patients with first degree 
atrioventricular block or asymptomatic left anterior fascicular block/right bundle 
branch block will not be excluded), or 
c. Congestive heart failure of New York Heart Association Class ≥3 or known left 
ventricular ejection fraction <40%, or 
d. Myocardial infarction within 3 months prior to C1D1. 
8. Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B 
has been given for >8 weeks and viral load is <100 IU/ml prior to first dose of trial treatment. 
Subjects with untreated hepatitis C virus (HCV) are allowed. Subjects with Human 
Immunodeficiency Virus (HIV) who have CD4+ T-cell counts ≥ 350 cells/µL and no history of 
AIDS-defining opportunistic infections in the last year are allowed. 
9. Any active gastrointestinal dysfunction interfering with the patient’s ability to swallow 
tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study 
treatment, including prior gastric bypass or bowel resection procedures. 
10. Inability or unwillingness to take supportive medications such as anti-nausea and anti-
anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) 
Clinical Practice Guidelines in Oncology (CPGO) (NCCN CPGO) for antiemesis and 
anorexia/cachexia (palliative care). 
11. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of 
the Investigator, could interfere with treatment, compliance, or the ability to give informed 
consent.  
12. Contraindication to any of the required concomitant drugs or supportive treatments. 
13. Patients unwilling or unable to comply with the protocol, including providing 24-hour urine 
samples for urine protein electrophoresis at the required time points. 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 15 of 105 
Confidential 
Sponsor-Investigator/Institution: 
University of Colorado, Anschutz 
Medical Campus 
Investigational Product (s): 
Selinexor (KPT-330) 
 
Developmental Phase: 
2 
Study Treatment/Treatment Groups, Dose, and Mode of Administration:  
Arm 1 SPd 
 Selinexor 60 mg PO days 1, 8, 15 
 Pomalidomide 4 mg PO on days 1-21   
 Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22 
 28-day treatment cycles 
 
Arm 2 SDd  
 Selinexor 80 mg PO days 1, 8, 15 
 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, 
days 1, 15 of cycles 3-6, day 1 of cycles >6 (may be substituted with IV Dara, if directed by 
Investigator) 
 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 
 28-day treatment cycle 
 
Arm 3 SKd 
 Selinexor 80 mg PO days 1, 8, 15 
 Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 
15. 
 Dexamethasone 40 mg IV or PO days 1, 8, 15, 22 
 28-day treatment cycle 
 
Duration of Treatment and Follow-up:  
There is no maximum treatment duration.  Patients will continue to receive treatment during the 
study until progression, death, toxicity or withdrawal from study.   
 
Following completion of therapy, patients will be monitored for survival and subsequent therapies 
annually for2 years. 
Statistical Methods: 
Efficacy will be assessed using the proportion of patients who achieve at least a partial response, as 
defined by IMWG criteria. The complementary failure rate—the rate of patients who do not achieve 
at least a partial response—will be assessed throughout the study. If at any time in the study the upper 
bound of the one-sided 90% confidence interval for the failure rate exceeds 51%, then the study will 
be stopped for efficacy. At study completion, the proportion of patients achieving at least a partial 
response will be calculated, along with one-sided 90% confidence intervals for this proportion. 
Assuming power of 80% and a one-sided type I error rate of 10%, then for a difference in proportion 
test using a normal approximation and assuming a null hypothesis of a 51% response rate and an 
alternative hypothesis of a 75% response rate, 18 patients are needed for this study. 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 16 of 105 
Confidential 
2 
SCHEDULE OF ASSESSMENTS AND STUDY SCHEMATICS 
Table 1 Schedule of Study Activities and Assessments – ARM 1(SPd) 
Activity/Assessment  
Screeninga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area (BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Symptom-directed PE 
 
 
 
Perform if clinically indicated) 
 
 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     LDH, CRP, TSH, PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
X 
 
 
 
 
 
X 
 
X 
 
X 
 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 17 of 105 
Confidential 
Activity/Assessment  
Screeninga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
     applicable)i 
(even  
cycles only) 
Dose Administration 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X  
(day 8, 15) 
X 
X  
(day 8, 15) 
 
 
     Pomalidomide (PO) 
 
X (days 1 – 21) 
 
X (days 1 – 21) 
X (days 1 – 21) 
 
 
     Dexamethasone (PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X  
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
UPEP (24-hr urine) and urine 
protein immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative Immunoglubilin 
levels (IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Plasmacytoma assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events recording 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
Continuous (Only SAEs related to study procedures during screening.   
Report until 30 days after last dose of  protocol required therapies) 
 
Concomitant medication 
recording 
 
Continuous 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 18 of 105 
Confidential 
Activity/Assessment  
Screeninga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
Collection of information 
regarding antineoplastic therapy 
used after EoT 
 
 
 
 
 
 
 
 
 
 
 
X 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: electrocardiogram; ECOG: Eastern Cooperative Oncology Group; 
EoT: end of treatment; hCG: human chorionic gonadotropin; ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating hormone>. 
a 
Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window and are done prior to signing the ICF. 
b 
After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for patients who have not progressed to assess durability of 
response. If MM evaluations cannot be performed, at a minimum, contact will be made to the patient (or the patient’s family) to assess the survival status, status of the 
patient’s MM, and overall medical condition of the patient and collect information on any antineoplastic therapies used after End of Treatment (see Section 8.5.3). These 
procedures should only be performed for subjects who have not had disease progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to 
the patient (or the patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any antineoplastic therapies utilized 
since last contact. 
c 
Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust supportive care as appropriate. The contact with the 
patient should take place on Day 3 following the Cycle 1 Day 1 selinexor dosing. 
d 
ICF must be signed before any study-specific procedures are performed. 
e 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a dose of selinexor >70 mg/m2. 
f 
Patients must rest for at least 5 minutes prior to the ECG recording. 
g 
Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and assessed on the same arm throughout the study. 
Vital signs do not need to be repeated if they are performed as part of the physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
h 
Details for clinical laboratory tests are provided in Table .   
i 
For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first dose of study treatment. Pregnancy testing (serum 
hCG or urine) is also required for females of childbearing potential prior to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy 
test must be documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be performed as clinically indicated during the 
study. 
j 
Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are the responsibility of the study Sponsor-Investigator.  
k 
Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and serum FLC assay on C1D1 and measurements must 
be taken either on Day -1 or pre-dose on C1D1 
l 
Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT may be used instead. Bone lesions seen at Screening 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 19 of 105 
Confidential 
should be re-assessed during the study using the same imaging modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as 
determined by the Investigator. 
m If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on Day 1 of each cycle and at the EoT visit. 
n Bone marrow samples 
a. 
Aspirates at Screening for: 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow 
Cytometry, both validated at a detection capacity of 10-5 
o 
After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein immunofixation, UPEP (24 hr.) with urine protein immunofixation, 
serum FLC, and quantitative Ig levels (and bone marrow aspirate and physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) will 
be performed every 3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, (and for patients who had PD and are therefore not 
followed for response), contact will be made to the patient (or the patient’s family) annually  for 2 years to inquire about the patient’s survival, MM status, general health, and 
information on any antineoplastic therapies utilized since End of Treatment. 
p 
Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any study-related procedures (including discussions with 
medical personnel and other study-related evaluations). 
q 
SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs must be submitted to KPT twice per year. See 
required template in Appendix 2  For information about cross-reported SUSARs from KPT’s CSTs, see memo in Appendix 3. 
r 
Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies for managing potential nausea and appetite changes 
experienced with selinexor. This may be completed between within the screening period for the study and prior to administration of study treatment on C1D1. The nutritional 
consultation can be done by a study investigator or nurse and can be done on a phone call. 
s 
Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
t 
These procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM aspirate and BMBX will be performed at baseline, then 
as applicable based on baseline results for response assessment through the trial.  
 
 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 20 of 105 
Confidential 
 
Table 2 Schedule of Study Activities and Assessments – ARM 2(SDd) 
Activity/Assessment  
Screening
a 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 
22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area (BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Symptom-directed PE 
 
 
 
Perform if clinically indicated) 
 
 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     LDH, CRP, TSH, PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
     applicable)i 
X 
 
 
 
 
 
X 
 
X 
(even  
cycles only) 
 
X 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 21 of 105 
Confidential 
Activity/Assessment  
Screening
a 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 
22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
Dose Administration 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 15) 
X 
X 
(day 8, 15) 
 
 
     Daratumumab (SQ/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
(day 15.   
Stop this dose 
at cycle 7+) 
 
 
     Dexamethasone (PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
UPEP (24-hr urine) and urine 
protein immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative Immunoglubilin 
levels (IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Plasmacytoma assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events recording 
 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
 
Continuous (Only SAEs related to study procedures during screening.   
Report until 30 days after last dose of  protocol required therapies) 
 
Concomitant medication 
recording 
 
Continuous 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 22 of 105 
Confidential 
Activity/Assessment  
Screening
a 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 
22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
Collection of information 
regarding antineoplastic therapy 
used after EoT 
 
 
 
 
 
 
 
 
 
 
 
X 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: electrocardiogram; ECOG: Eastern Cooperative Oncology Group; 
EoT: end of treatment; hCG: human chorionic gonadotropin; ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating hormone>. 
a 
Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window and are done prior to signing the ICF. 
b 
After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for patients who have not progressed to assess durability of 
response. If MM evaluations cannot be performed, at a minimum, contact will be made to the patient (or the patient’s family) to assess the survival status, status of the 
patient’s MM, and overall medical condition of the patient and collect information on any antineoplastic therapies used after End of Treatment (see Section 8.5.3). These 
procedures should only be performed for subjects who have not had disease progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to 
the patient (or the patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any antineoplastic therapies utilized 
since last contact. 
c 
Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust supportive care as appropriate. The contact with the 
patient should take place on Day 3 following the Cycle 1 Day 1 selinexor dosing. 
d 
ICF must be signed before any study-specific procedures are performed. 
e 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a dose of selinexor >70 mg/m2. 
f 
Patients must rest for at least 5 minutes prior to the ECG recording. 
g 
Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and assessed on the same arm throughout the study. 
Vital signs do not need to be repeated if they are performed as part of the physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
h 
Details for clinical laboratory tests are provided in Table .   
i 
For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first dose of study treatment. Pregnancy testing (serum 
hCG or urine) is also required for females of childbearing potential prior to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy 
test must be documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be performed as clinically indicated during the 
study. 
j 
Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are the responsibility of the study Sponsor-Investigator.  
k 
Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and serum FLC assay on C1D1 and measurements must 
be taken either on Day -1 or pre-dose on C1D1 
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l 
Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT may be used instead. Bone lesions seen at Screening 
should be re-assessed during the study using the same imaging modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as 
determined by the Investigator. 
m If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on Day 1 of each cycle and at the EoT visit. 
n Bone marrow samples 
a. 
Aspirates at Screening for: 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow 
Cytometry, both validated at a detection capacity of 10-5 
o 
After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein immunofixation, UPEP (24 hr.) with urine protein immunofixation, 
serum FLC, and quantitative Ig levels (and bone marrow aspirate and physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) will 
be performed every 3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, (and for patients who had PD and are therefore not 
followed for response), contact will be made to the patient (or the patient’s family) annually for 2 years to inquire about the patient’s survival, MM status, general health, and 
information on any antineoplastic therapies utilized since End of Treatment. 
p 
Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any study-related procedures (including discussions with 
medical personnel and other study-related evaluations). 
q 
SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs must be submitted to KPT twice per year. See 
required template in Appendix 2  For information about cross-reported SUSARs from KPT’s CSTs, see memo in Appendix 3. 
r 
Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies for managing potential nausea and appetite changes 
experienced with selinexor. This may be completed between within the screening period for the study and prior to administration of study treatment on C1D1. The nutritional 
consultation can be done by a study investigator or nurse and can be done on a phone call. 
s 
Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
t 
These procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM aspirate and BMBX will be performed at baseline, then 
as applicable based on baseline results for response assessment through the trial.  
 
 
 
 
 
 
 
 
 
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IRB # 20-2202 
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Table 3 Schedule of Study Activities and Assessments – ARM 3 (SKd) 
Activity/Assessment  
Screening
a 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 
22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area (BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Symptom-directed PE 
 
 
 
Perform if clinically indicated) 
 
 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     LDH, CRP, TSH, PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
     applicable)i 
X 
 
 
 
 
 
X 
 
X 
(even  
cycles only) 
 
X 
 
Dose Administration 
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Activity/Assessment  
Screening
a 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 
22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 15) 
X 
X 
(day 8, 15) 
 
 
     Carfilzomib (SQ/IV) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 15) 
X 
X 
(day 8, 15) 
 
 
     Dexamethasone (PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
UPEP (24-hr urine) and urine 
protein immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative Immunoglubilin 
levels (IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Plasmacytoma assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events recording 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
Continuous (Only SAEs related to study procedures during screening.  
 Report until 30 days after last dose of  protocol required therapies) 
 
Concomitant medication 
recording 
 
Continuous 
 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
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IRB # 20-2202 
V5, 02JAN2025 
Page 26 of 105 
Confidential 
Activity/Assessment  
Screening
a 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatment  
(EoT) Visit 
Durability of 
Response 
(Every 3 
months) and 
Survival  
Follow-upb 
(Yearly) 
Day -28 to 
Day 1 
Day  
1  
Day 3 
Phone 
Callc 
Day 
8 
Day 
15 
Day 
22 
Day 1 
Day 8, 15, 
22 
Day 1 
Day 8, 15, 
22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
day 
± 1 
day 
± 1 
day 
± 2 days 
± 2 days 
± 2 days 
± 2 days 
 
± 14 days 
Collection of information 
regarding antineoplastic therapy 
used after EoT 
 
 
 
 
 
 
 
 
 
 
 
X 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: electrocardiogram; ECOG: Eastern Cooperative Oncology Group; 
EoT: end of treatment; hCG: human chorionic gonadotropin; ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating hormone>. 
a 
Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window and are done prior to signing the ICF. 
b 
After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for patients who have not progressed to assess durability of 
response. If MM evaluations cannot be performed, at a minimum, contact will be made to the patient (or the patient’s family) to assess the survival status, status of the 
patient’s MM, and overall medical condition of the patient and collect information on any antineoplastic therapies used after End of Treatment (see Section 8.5.3). These 
procedures should only be performed for subjects who have not had disease progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to 
the patient (or the patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any antineoplastic therapies utilized 
since last contact. 
c 
Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust supportive care as appropriate. The contact with the 
patient should take place on Day 3 following the Cycle 1 Day 1 selinexor dosing. 
d 
ICF must be signed before any study-specific procedures are performed. 
e 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a dose of selinexor >70 mg/m2. 
f 
Patients must rest for at least 5 minutes prior to the ECG recording. 
g 
Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and assessed on the same arm throughout the study. 
Vital signs do not need to be repeated if they are performed as part of the physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
h 
Details for clinical laboratory tests are provided in Table .   
i 
For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first dose of study treatment. Pregnancy testing (serum 
hCG or urine) is also required for females of childbearing potential prior to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy 
test must be documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be performed as clinically indicated during the 
study. 
j 
Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are the responsibility of the study Sponsor-Investigator.  
k 
Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and serum FLC assay on C1D1 and measurements must 
be taken either on Day -1 or pre-dose on C1D1 
l 
Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT may be used instead. Bone lesions seen at Screening 
should be re-assessed during the study using the same imaging modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 27 of 105 
Confidential 
determined by the Investigator. 
m If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on Day 1 of each cycle and at the EoT visit. 
n Bone marrow samples 
a. 
Aspirates at Screening for: 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow 
Cytometry, both validated at a detection capacity of 10-5 
o 
After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein immunofixation, UPEP (24 hr.) with urine protein immunofixation, 
serum FLC, and quantitative Ig levels (and bone marrow aspirate and physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) will 
be performed every 3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, (and for patients who had PD and are therefore not 
followed for response), contact will be made to the patient (or the patient’s family) annually for 2 years to inquire about the patient’s survival, MM status, general health, and 
information on any antineoplastic therapies utilized since End of Treatment. 
p 
Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any study-related procedures (including discussions with 
medical personnel and other study-related evaluations). 
q 
SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs must be submitted to KPT twice per year. See 
required template in Appendix 2  For information about cross-reported SUSARs from KPT’s CSTs, see memo in Appendix 3. 
r 
Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies for managing potential nausea and appetite changes 
experienced with selinexor. This may be completed between within the screening period for the study and prior to administration of study treatment on C1D1. The nutritional 
consultation can be done by a study investigator or nurse and can be done on a phone call. 
s 
Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
t 
These procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM aspirate and BMBX will be performed at baseline, then 
as applicable based on baseline results for response assessment through the trial.  
 
 
 
 
 
 
 
 
 
 
 
 
 
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 28 of 105 
Confidential 
Figure 1  
Study Flow Chart 
 
MyDST 
Test 
Abbreviations: SPd= selinexor + pomalidomide + dexamethasone; SDd = selinexor + daratumumab + dexamethasone; SKd = selinexor + carfilzomib + dexamethasone 
Patients will continue on therapy until progression or unacceptable toxicity 
 Screened 
Arm 1 SPd 
Selinexor 60 mg PO days 1, 8, 15 
Pomalidomide 4 mg PO on days 1-21   
Dexamethasone 40 mg IV or PO on days 1, 8, 15, 22 
28 day treatment cycles 
Arm 2 SDd  
Selinexor 80 mg PO days 1, 8, 15 
Daratumumab 1,800mg/30,000 units SQ injection days 1, 8, 
15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of 
cycles >6 (may be substituted with IV Dara, if directed by 
Investigator) 
Dexamethasone 40 mg IV or PO days 1, 8, 15, 22 
28 day treatment cycle
Arm 3 SKd 
Selinexor 80 mg PO days 1, 8, 15 
Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 
cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15. 
Dexamethasone 40mg IV or PO days 1, 8, 15, 22 
28 day treatment cycle  
Enrolled 
Investigator Selected 
Treatment Arm 
Assigned 
Assigned 
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IRB # 20-2202 
V5, 02JAN2025 
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3 
INTRODUCTION 
3.1 
Multiple Myeloma 
Multiple Myeloma (MM) is the second most common hematologic malignancy and is increasing 
in frequency. In 2017 there were approximately 30,000 new cases of MM diagnosed in the United 
States and 12,600 MM related deaths (Siegel, Miller, & Jemal, 2019). The past 2 decades have 
seen 11 new drug approvals in multiple myeloma (MM) which have dramatically altered 
treatment approaches in this disease and led to improved patient outcomes (Kumar, Dimopoulos, 
et al., 2017). Despite these improvements MM remains an incurable blood cancer with nearly all 
patients experiencing relapse after initial therapy and often requiring several salvage treatment 
approaches (Laubach et al., 2016). Drug classes which are regularly used in relapsed multiple 
myeloma include immunomodulatory agents (IMiDs), proteasome inhibitors (PIs), monoclonal 
antibodies, conventional chemotherapeutics and corticosteroids. Recently the field has expanded 
with the approval of Selinexor (Xpovio), the first in class selective inhibitor of nuclear export.   
Current National Comprehensive Cancer Network (NCCN) guidelines for management of patient 
with previously treated multiple myeloma include 8 preferred regimen options and 23 “Other 
Recommended Regimens” (Kumar, Callander, et al., 2017). This diversity of treatment options 
in RRMM leads to challenges in therapeutic decision-making. There is limited direct data to 
guide clinicians in choosing between available treatment options. The large majority of available 
regimens have not been compared directly to one other in controlled trials. Furthermore, although 
risk stratification in multiple myeloma exists and can help predict overall disease aggressiveness, 
to date there has not been identification of myeloma related biomarkers that may help to predict 
relative efficacy of different active agents or development of validated risk adapted therapeutic 
recommendations for management of RRMM (Fonseca et al., 2009; Sonneveld et al., 2016).  
3.2 
Selinexor 
Selinexor is being evaluated for the treatment of hematologic and solid tumor indications, 
including multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL), and advanced 
unresectable dedifferentiated liposarcoma (DDLS).  On July 3, 2019 selinexor was granted 
accelerated approved by the Food and Drug Administration (FDA) in combination with 
dexamethasone for patients with RRMM who have received at least four prior therapies and 
whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory 
agents and an anti-CD38 monoclonal antibody.  On June 22, 2020 granted selinexor it’s second 
approval this time in patients with relapsed or refractory DLBCL after at least 2 lines of systemic 
therapy. 
To date, more than 3,000 patients with hematologic or solid tumors have received selinexor in 
clinical studies, including Company-sponsored Trial (CSTs), Investigator-Sponsored Trials 
(ISTs), and the Selinexor Expanded Access Program (EAP), in >10 disease indications. The 
majority of patients were treated with selinexor as a single agent but >700 patients received 
selinexor in combination with a diverse array of other anticancer agents. Single-agent Phase 1 
studies with oral selinexor have been conducted in advanced hematological malignancies 
including MM, acute myeloid leukemia (AML), NHL, and chronic lymphocytic leukemia; in 
solid tumors; and in soft tissue and bone sarcomas. Broad antitumor activity has been observed 
in all of these studies. In addition, Phase 2 studies have been conducted in Richter’s 
transformation and AML and are ongoing in MM, DLBCL, glioblastoma, gynecological 
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malignancies, and dedifferentiated liposarcoma (Phase 2 and 3). A separate Phase 3 study is 
ongoing in MM. Additional information about clinical studies of selinexor is available in the 
Selinexor Investigator’s Brochure (IB), version 9, dated August 13, 2019. 
The current study will evaluate selinexor combined with dexamethasone and common backbone 
agents daratumumab, pomalidomide or carfilzomib for the treatment of RRMM. 
3.2.1 
Selinexor Mechanism of Action 
Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export 
(SINE) compound that specifically blocks exportin 1 (XPO1).  
XPO1 is overexpressed in a large variety of malignancies including multiple myeloma (MM), 
osteosarcoma, pancreatic cancer, ovarian cancer, glioma, leukemia, and lymphoma and correlates 
with advanced disease, resistance to therapy, and poor survival. XPO1 exports tumor suppressor 
proteins (TSPs; eg, p53, p73, pRb, FOXOs, APC, PTEN) and growth regulatory proteins (GRPs; 
eg, IB, p21, p27, Survivin) out of the nucleus. These protein cargos mediate their cell cycle 
checkpoint/tumor suppression functions within the nucleus. Therefore, nuclear to cytoplasmic 
transport of these proteins by XPO1 leads to their functional inactivation. XPO1 also regulates 
the cytoplasmic localization and, in turn, translation of key proto oncogenic mRNAs (eg, MYC, 
BCL2, BCL6 and cyclin D) that complex with the XPO1 cargo protein, eukaryotic initiation 
factor 4E (eIF4E). In addition, XPO1 is involved in regulating nuclear levels of the glucocorticoid 
receptor (GR). 
Inhibition of XPO1 by selinexor promotes apoptosis in malignant cells by blocking each of the 
above XPO1-mediated mechanisms. Because these mechanisms are relevant to any neoplastic 
cell, selinexor has the potential to effectively treat a range of malignancies. Normal cells undergo 
reversible cell cycle arrest following inhibition of XPO1 and recover when the block is removed. 
Further information regarding the mechanism of action can be found in the Selinexor IB. 
3.2.2 
Selinexor Nonclinical Studies 
Tumor reduction and increased survival was observed at doses of selinexor 15 through 60 mg/m2 
(5 through 20 mg/kg) in mouse models of hematological and solid tumors. In addition, marked 
synergy was observed when selinexor was combined with a variety of chemotherapies and 
targeted therapies.  
The major side effects across all animal models studied were reduced appetite with anorexia 
induced weight loss or reduction in weight gain. Cachexia (loss of muscle mass) was not 
observed. Similar effects are observed in humans, where high caloric foods and appetite 
stimulants, including glucocorticoids, are known to improve appetite and mitigate weight loss. 
Further information regarding selinexor nonclinical studies can be found in the Selinexor IB. 
3.2.3 
Overall Clinical Experience with Selinexor 
 Pharmacokinetics 
Selinexor is orally bioavailable and exhibits dose-proportional exposure with moderate to high 
interpatient variability across a wide dose range of doses in patients with advanced hematologic 
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malignancies or solid tumors. The elimination (terminal) half-life of selinexor is approximately 
5 to 8 hours. Additional details are available in the Selinexor IB. 
 Safety and Efficacy  
Over 3,366 patients with hematologic or solid-tumor malignancies have been treated with 
selinexor in CSTs, ISTs, and the Selinexor EAP.  
The most commonly reported treatment-emergent adverse events (TEAEs) in CSTs have been 
generally low-grade and reversible nausea, fatigue, anorexia (including decreased appetite), 
vomiting, and diarrhea. TEAEs of thrombocytopenia and anemia, which can be higher grade, 
were reported primarily in patients with hematologic malignancies. 
The most frequently reported non-hematologic treatment-related adverse events (TRAEs) 
reported in CSTs have been fatigue, GI disorders, and anorexia. These TRAEs respond to 
supportive care measures and/or dose interruption/reduction. Careful attention to these side 
effects, particularly in the first 4 to 6 weeks of dosing, is critical. Additional non-hematologic 
TRAEs that have occurred in ≥10% of patients in CSTs include hyponatremia, blurred vision and 
increased risk of cataracts in patients with prolonged exposure to selinexor with dexamethasone 
and dizziness. Hematologic toxicities, including thrombocytopenia, anemia, and neutropenia, 
have been observed and typically respond to dose modifications, growth factors, and/or 
transfusions. 
Although some patients with rapid tumor responses experience significant fatigue, nausea, 
malaise and/or asthenia after 1 or more doses of selinexor, this effect has not been associated 
with typical markers of tumor lysis syndrome (TLS). Eight TLS cases have been reported (as of 
31 March 2019), including 4 patients in CSTs, 2 patients in ISTs, and 2 patients in the selinexor 
EAP. If TLS is suspected, assessment of tumor response is strongly recommended in order to 
better inform treatment recommendations. 
Preliminary findings from ongoing clinical studies have shown that selinexor induces durable 
antitumor responses across a broad range of R/R hematologic and solid tumor cancers, including 
MM, DLBCL, AML, and DDLS, which is consistent with its proposed mechanism of action. In 
general, these effects appear to be independent of tumor type or prior treatment(s). 
More information about the safety and efficacy of selinexor is available in the current Selinexor 
IB. 
3.2.4 
Treatments That Will Be Used in Combination with Selinexor  
 Pomalidomide (Pomalyst®) 
Pomalidomide (Pomalyst®) is an immunomodulatory agent, IMiD, which was 
developed as a thalidomide analogue. Derived as a dramatically more potent 
inhibitor of tumor necrosis factor than its parent compound, pomalidomide was more 
subsequently found to exert its anti-tumoral activity by altering the activity of 
Cereblon, a component of an E3 ubiquitination ligase complex, to increase 
degradation of the cellular proteins Ikaros and Aiolos (Hideshima et al., 2000; 
Kronke, Hurst, & Ebert, 2014; Lu et al., 2014). As pomalidomide is structurally and 
pharmacologically related to thalidomide, a known teratogen, it is contraindicated in 
pregnant women and women who have a possibility of becoming pregnant. The 
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pomalidomide product monographs/labeling contain the following boxed-text 
warning: 
WARNING: 
EMBRYO-FETAL 
TOXICITY 
(and 
VENOUS 
THROMBOEMBOLISM) 
See full prescribing information for complete boxed warning 
EMBRYO-FETAL TOXICITY 
Pomalidomide is contraindicated in pregnancy. 
Pomalidomide is a thalidomide analogue. Thalidomide is a known 
human teratogen that causes severe life-threatening birth defects. 
For females of reproductive potential: Exclude pregnancy before start of 
treatment. Prevent pregnancy during treatment by the use of 2 reliable methods 
of contraception. 
Pomalidomide is available only through a restricted program called 
POMALYST REMS 
In order to prevent pregnant women from being exposed to pomalidomide, a 
Risk Evaluation and Mitigation Strategy (REMS) called POMALYST REMS in 
the EU and US, and RevAid® in Canada, has been established by the 
manufacturer of both products. In order to participate in Arm 1 of this study, 
investigators and patients must agree to comply with the requirements of the 
plans. 
Initial phase I testing identified myelosuppression as the dose limiting toxicity of IMiD therapy 
in MM, subsequent clinical trial experience also demonstrated the risk of treatment related 
thromboembolic events and the need for and efficacy of prophylactic anticoagulation during 
therapy (Palumbo et al., 2008; Richardson et al., 2002). The activity of pomalidomide in RRMM 
was described in the landmark phase III MM-003 study which demonstrated markedly increased 
ORR, increased PFS and OS for pomalidomide and dexamethasone therapy in comparison to the 
high dose dexamethasone alone control arm (San Miguel et al., 2013).  
 
Pomalidomide has subsequently been evaluated in numerous phase II and III studies in relapsed 
multiple myeloma as a 2-drug combination with dexamethasone or as part of 3-drug 
combinations with dexamethasone and additional partners including bortezomib, carfilzomib, 
daratumumab, elotuzumab, cyclophosphamide and clarithromycin (Mark et al., 2019). Full 
prescribing information is available for reference for the most current clinical experience and 
safety 
and 
reproductive 
risk 
information 
for 
pomalidomide 
(available 
at 
https://media.celgene.com/content/uploads/pomalyst-pi.pdf).  
 
Daratumumab 
Daratumumab (Darzalex) is a monoclonal antibody targeting the CD38 glycoprotein which has 
near uniform expression on malignant plasma cells from patients with MM (de Weers et al., 
2011). Daratumumab has been shown to exert an anti-myeloma effect through several 
mechanisms including complement dependent cytotoxicity, antibody-dependent cell-mediated 
cytotoxicity, macrophage-mediated phagocytosis, the induction of programmed cell death and 
apoptosis as well as blocking the enzymatic activity of CD38 (de Weers et al., 2011; Overdijk et 
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al., 2016; Overdijk et al., 2015; van Bueren et al., 2014). Daratumumab activity in the RRMM 
setting was first demonstrated in 2 phase I/II trials using daratumumab monotherapy in heavily 
pretreated patients (Lokhorst et al., 2015; Lonial et al., 2016). These demonstrated overall 
response rates of approximately 30% with limited toxicities aside from infusion related reactions 
with initial dosing and low-grade myelosuppression, leading to initial FDA approval. The 
landmark phase III CASTOR and POLLUX trials evaluated daratumumab in patients with less 
prior treatment exposure (1-3 prior lines of therapy) in combination with either a PI (CASTOR: 
daratumumab/bortezomib/Dex 
vs 
bortezomib/dex) 
or 
an 
IMiD 
(POLLUX: 
daratumumab/lenalidomide/Dex vs lenalidomide/Dex) (Dimopoulos, Oriol, et al., 2016; 
Palumbo et al., 2016). These studies both demonstrated significant improvements in PFS and 
response rates at all levels evaluated for the patients that received daratumumab in comparison 
to the control arm with very manageable additive toxicities. Full prescribing information is 
available for reference from the most current clinical experience and safety and reproductive risk 
information 
for 
daratumumab 
(available 
at 
http://www.janssenlabels.com/package-
insert/product-monograph/prescribing-information/DARZALEX-pi.pdf). 
 Carfilzomib 
Carfilzomib (Kyprolis) is an irreversible, second generation proteasome inhibitor (PI) with 
increased inhibition of the chymotrypsin-like subunit of the proteasome, compared to bortezomib 
(Kuhn et al., 2007; Parlati et al., 2009). Preclinical and early phase I studies established a twice 
weekly dosing schema, days 1, 2, 8, 9, 15 and 16 of 28, for carfilzomib which was instituted for 
clinical development (O'Connor et al., 2009). Use of an initial 20 mg/m2 dosing for days 1 and 2 
of cycle one with subsequent escalation to 27 mg/m2 was established as the MTD for carfilzomib 
with dexamethasone in the phase I/II studies using an administration time of 2-10 minutes. 
Carfilzomib 20/27 with dexamethasone was found to have significant activity in RRMM and was 
approved by the FDA for use in this setting based on the strong results from phase II testing, 
particularly the PX-171-004 study (Vij et al., 2012). Subsequent evaluations demonstrated a 
significant decrease in peak plasma levels and diminished toxicity profile with slower 
administration and further phase I testing established the safety of carfilzomib doses up to 56 
mg/m2 when administered over 30-minutes on the same twice weekly schema with initial dosing 
(Papadopoulos et al., 2015). Recently studies have demonstrated the safety and efficacy of 
weekly dosing. The phase I/II CHAMPION demonstrated the safety and efficacy of once-weekly 
carfilzomib with a target dose of 70mg/m2(Berenson et al., 2016). Recently reported results from 
the phase III ARROW study compared twice weekly carfilzomib at a dosing of 27 mg/m2 versus 
weekly dosing of 70 m2 in 478 patients with RRMM and demonstrated longer PFS in the weekly 
dosing arm, 11.2 months vs 7.6, HR=0.69 (95% CI 0.54-0.88).   
 
Carfilzomib activity was further established in the phase III ENDEAVOR trial which compared 
carfilzomib and Dex (Kd) with bortezomib and Dex (Vd) for treatment of RRMM (Dimopoulos, 
Moreau, et al., 2016). This study used a dosing of carfilzomib of 56 mg/m2 and did include a 
significant portion of patients with prior bortezomib exposure. Median progression free survival 
for the Kd cohort was 18.7 months versus 9.4 months for Vd (HR 0.53, CI 0.44-0.65; p<0.0001).  
Planned subgroup analysis for patients with prior bortezomib exposure demonstrated a similar 
benefit for Kd, median PFS 15.6 vs 8.1 month (HR 0.56, CI 0.44-0.73). Recently overall survival 
data was presented which demonstrated that patients in the Kd arm had longer median overall 
survival, 47.6 months, then patients treated with Vd, 40 months (HR 0.79, 95% CI 0.65-0.96; p-
0.01). 
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Full prescribing information is available for reference for the most current clinical experience 
and 
safety 
and 
reproductive 
risk 
information 
for 
 
carfilzomib 
(available 
at 
https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-
com/kyprolis/kyprolis_pi.pdf). 
3.2.5 
Myeloma Drug Sensitivity Testing 
To address the issue of rational drug selection for patients with myeloma, we have developed an 
ex vivo assay, termed My-DST (Myeloma Drug Sensitivity Testing) (Walker et al., 2020). For 
My-DST, primary patient bone marrow aspirates undergo Ficoll mononuclear cell separation and 
are then screened for plasma cell survival in a 96-well plate against a panel of anti-myeloma 
drugs in solution. This functional assay avoids CD138+ cell selection of bone marrow aspirates 
to optimize viability of plasma cells by maintaining their usual cellular support environment and 
also allows for the determination for monoclonal antibody response through cell-mediated 
cytotoxicity mechanisms.  
 
In the development of the My-DST platform, dose response relationships were determined for 
clinically used agents, including pomalidomide, carfilzomib, daratumumab and dexamethasone. 
Concentrations that produced an reproducible decrease in MM cell viability in sensitive patients 
were selected for each drug individually for the screening format of the working platform. For 
high-throughput testing, the concentrations selected were 2.5 nM for PIs, 10 µM for IMiDs, 1 
µM for dexamethasone and 20 nM for daratumumab. Ex vivo incubation is performed for 48 
hours, followed by flow cytometry using widely accepted markers for MM cells: CD138, CD38, 
CD45 and CD19. Viability of the MM cell population is then measured by viability dye 
exclusion, and results reported with normalization compared to vehicle-treated controls. Drug 
treatments at these standardized single concentrations with <80% cell survival in My-DST are 
considered to be active agents.   
Using this approach, retrospective evaluation of 55 MM patients’ samples My-DST results was 
compared to the clinical outcomes of the patients. When patients received solely agents that were 
tested in My-DST, the ex vivo results were 96% sensitive and 88% specific for a clinical partial 
response (50% decrease in disease burden by IMWG criteria) to subsequent therapy (Walker et 
al., 2020). My-DST has demonstrated good reproducibility, and the sensitivities of PIs, IMiDs 
and daratumumab correlated inversely with the number of prior therapies, and the patients’ prior 
drug exposures. Patient samples can be analyzed, and results interpreted in less than 96 hours 
allowing the test to inform subsequent treatment decision making without delaying care. For the 
next step in determining the predictiveness of My-DST, a stratified, prospective study of how 
well ex vivo results correspond to patients’ clinical responses is necessary.  
3.3 
Study and Dose Rationale 
3.3.1 
Rationale for the Study and the Study Design 
Given its unique mechanism of action selinexor presents an attractive partner for several 
commonly used therapeutic agents in RRMM.  The ongoing phase Ib/II STOMP trial is 
evaluating selinexor as part of several multidrug regimens incorporating the most active currently 
available myeloma therapeutics. The STOMP trial includes dose finding and expansion cohorts 
to describe initial efficacy and toxicity for selinexor and dexamethasone in combination with the 
proteasome inhibitor carfilzomib, the immunomodulatory agent pomalidomide and the CD38 
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targeting monoclonal antibody daratumumab among other combinations. However, as with other 
therapeutic choices in relapsed and refractory multiple myeloma the decision for which of these 
partners to join with selinexor therapy is largely empiric.  
Ex vivo drug sensitivity testing using the My-DST assay has the potential to use a functional 
assessment of each individual patient’s multiple myeloma to help identify the optimal agents to 
increase likelihood of treatment response. We propose to evaluate the efficacy of physician’s 
choice therapy for RRMM using selinexor based 3-drug combinations selected by investigators 
expert judgement. Patients will undergo concurrent My-DST testing prior to the start of therapy 
to characterize My-DST performance in a prospective manner. The My-DST results will be used 
for exploratory analyses only and will not be available to providers at time of treatment arm 
selection. 
3.3.2 
Dose Schedule Rationale 
 Selinexor Dosing 
Based on the pharmacology, pharmacokinetics, pharmacodynamics (PD), tolerability, and 
efficacy observed in clinical studies, the recommended dose for the use of single-agent selinexor 
in most cancer indications is 60 mg twice weekly (BIW), administered on Days 1 and 3 of each 
week, continuously. In patients with heavily pretreated MM, the combination of 80 mg selinexor 
plus 20 mg dexamethasone BIW was identified as the RP2D (Karyopharm internal report: 
Selinexor Exposure-Response White Paper, 06 April 2017) and this dose has been shown to be 
active in penta-refractory MM. When selinexor is combined with other anti-neoplastic agents, it 
can often be given once weekly (QW) at doses of 60 to 100 mg each week.. Given potential for 
overlapping hematologic toxicities with pomalidomide 60 mg weekly dosing was selected as 
selinexor dose as part of SPd combination (arm 1).  Hematologic toxicity is less prominent with 
daratumumab and carfilzomib so 80 mg weekly dosing for selinexor is planned for SDd and SKd 
combinations (Arms 2 and 3) 
 Pomalidomide Dosing  
Pomalidomide is approved for administration as a 4 mg oral capsule on days 1 through 21 of 28 
day treatment cycle.   
 Daratumumab Dosing  
Daratumumab is approved for administration at a dose of 1,800mg/30,000 units subcutaneously 
(may be substituted with IV Dara, if directed by Investigator).  It is administered on days 1, 8, 
15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6 and day 1 of cycle >6.   
 Carfilzomib Dosing  
Carfilzomib is approved for administration on a once weekly schedule with dose of 20 mg/m2 
on D1 of cycle one followed by 70 mg/m2 on days 1, 8 and 15 of 28 days schedule in combination 
with dexamethasone. When used in combination with agents that may have increased risk for 
overlapping toxicities 56 mg/m2 is being utilized as weekly dosing in ongoing clinical trials.  A 
dose of 56 mg/m2 will be used in planned combination with selinexor and dexamethasone.  
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3.3.3 
Benefit/Risk Assessment  
In clinical studies evaluating selinexor, broad antitumor activity has been observed with continual 
selinexor treatment. A summary of the clinical studies and the antitumor responses observed in 
each study is provided in the Selinexor IB. 
In ongoing clinical studies, the most common AEs reported as at least possibly related to 
selinexor in CSTs have been low-grade nausea, fatigue, anorexia, thrombocytopenia, and 
vomiting. Most of these AEs can be managed effectively with dose modification and/or 
supportive care initiated prior to first dose. In addition, 8 tumor lysis syndrome (TLS) cases have 
been reported (as of March 2019). No fatal outcomes due to TLS have been reported in any 
studies with selinexor, or in the ongoing expanded access program. Although the incidence of 
TLS is low (~0.3%), the causal relationship between selinexor treatment and TLS cannot be 
completely excluded. Early recognition of signs and symptoms in patients at risk for TLS, 
including identification of abnormal clinical and laboratory values, is key and Investigators must 
ensure that patients being treated with selinexor maintain adequate caloric and fluid intake. Close 
monitoring and management of patients with hematological malignancies, including MM, for 
potential signs and symptoms of TLS are most relevant. See Section 7.13.2 for supportive care 
and Table 6 for selinexor dose modification guidance More detailed information about the known 
and expected benefits and risks of selinexor is provided in the Selinexor IB. 
Selinexor in combination with partner agents including pomalidomide, carfilzomib, 
daratumumab along with dexamethasone are being evaluated in the ongoing phase 1b/2 STOMP 
trial.  Primary objective for the dose escalation phase of this study includes identification of 
RP2D for each combination with weekly dosing, these results were incorporated into this studies 
design to minimize potential toxicities. Pomalidomide, carfilzomib and daratumumab have some 
potential for overlapping toxicities with selinexor which will be monitored closely with plan for 
management per protocol specifications. 
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4 
STUDY OBJECTIVES 
Objectives and Endpoints 
 
Objectives 
Endpoints 
Primary 
 To evaluate the overall response rate 
achieved with physician’s choice 
selinexor-based combination therapy 
ORR by IMWG criteria (based on Kumar et 
al 2016) [appendix 5] 
Secondary 
 To evaluate the minimal residual 
disease negative response rate 
achieved with physician’s choice 
selinexor-based combination therapy 
 To evaluate the duration of disease 
control and survival for patients 
treated with physician’s choice 
selinexor-based combination therapy 
 To evaluate safety and tolerability of 
selinexor in combination with partner 
backbone agents 
MRD negative response rate assessed via 
NGS or multiparametric flow cytometry 
with sensitivity of 10-5 
  
 
PFS, DOR, OS, TTNT 
 
 
Occurrence, nature and severity of 
Adverse Events  
 
Exploratory 
 Feasibility of My-DST testing to 
inform treatment choice  
 Evaluation of My-DST related 
predictors of response 
Rate of assay failure; Rate of 
identification of preferred partner therapy 
or combination 
ORR in patients with concordance or 
discordance between My-DST results and 
physicians selected regimen 
 
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5 
STUDY DESIGN 
This study will be a single institution, open-label phase II study to evaluate the overall response 
rate achieved with physician’s choice selinexor and dexamethasone based three-drug 
combination therapy in RRMM.  Patients with relapsed/refractory multiple myeloma will be 
eligible for enrollment.   
 
During screening, bone marrow aspirate will be collected and in addition to standard of care 
testing will be evaluated using the My-DST platform. The following agents will be evaluated for 
sample sensitivity: pomalidomide, carfilzomib and daratumumab. Agents will be tested 
individually, in combination with selinexor and in combination with selinexor and 
dexamethasone. My-DST performance characteristics and results will be used for exploratory 
analyses but will not be available to providers at time of, or incorporated into treatment decision 
making. Providers will choose to assign patients to one of the following treatment regimens based 
on clinical judgement/expertise: SPd (arm 1), SDd (arm 2) or SKd (arm 3), dosing is described 
for combinations in figure 1 and schedules in table 2. Providers will identify their planned 
treatment arm for each patient using their best clinical judgement. Treatment will be continued 
until progression of disease on unacceptable toxicity. 
 
 
6 
STUDY POPULATION 
6.1 
Study Population 
The study will enroll patients with relapsed or refractory MM. 
6.2 
Inclusion Criteria  
Patients must meet all of the following inclusion criteria to be eligible to enroll in this study: 
1. Age ≥ 18 years 
2. Willing and able to provide written informed consent in accordance with federal, local, and 
institutional guidelines. The patient must provide informed consent prior to the first screening 
procedure.  
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2  
4. Histologically confirmed diagnosis, measurable disease and evidence of disease progression 
of MM after 1 or more prior lines of therapy with either of: 
a) Documented evidence of PD after achieving at least SD for ≥ 1 cycle during a previous 
MM regimen (i.e., relapsed MM) 
b) ≤ 25% response (i.e, patient never achieved ≥ MR) or PD during or within 60 days from 
end of the most recent MM regimen (i.e., refractory MM) 
5. Patients must have measurable disease as defined by at least one of the following: 
a) Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or, for IgA 
myeloma, by quantitative IgA 
c) Urinary M-protein excretion at least 200 mg/24 hours 
d) Serum FLC ≥ 10 mg/dL, provided that FLC ratio is abnormal 
e) If no measurable disease by serum or urine, then the presence of a plasmacytoma of ≥ 
2cm in one dimension prior to start of study can be used to follow response via radiologic 
imaging 
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6. Adequate hepatic function: 
f) Total bilirubin <1.5 × upper limit of normal (ULN) (except patients with Gilbert’s 
syndrome who must have a total bilirubin of <3 × ULN), and 
g) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × ULN. 
7. Adequate renal function as determined by serum creatinine of ≤ 2 mg/dL OR estimated 
creatinine clearance of ≥ 20 mL/min, calculated using the Cockcroft and Gault formula (140 
– Age) • Mass (kg)/ (72 • creatinine mg/dL); multiply by 0.85 if female (Cockcroft 1976).  
8. Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count 
≥1000/mm3, hemoglobin ≥8 g/dL and platelet count ≥100,000/mm3 (patients for whom <50% 
of bone marrow nucleated cells are plasma cells) or ≥50,000/mm3 (patients for whom ≥50% 
of bone marrow nucleated cells are plasma cells). 
a) Patients may receive hematopoietic growth factor support, including erythropoietin, 
darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-
colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, 
romiplostim, or interleukin-11) at any time 
b) Patients may receive RBC and/or platelet transfusions as clinically indicated per 
institutional guidelines during the study. 
9. Female patients of childbearing potential must have a negative serum pregnancy test at 
Screening. Female patients of childbearing potential and fertile male patients who are 
sexually active with a female of childbearing potential must use highly effective methods of 
contraception throughout the study and for 3 months following the last dose of protocol 
required therapies. Highly effective methods of contraception are listed in Section 9.3.1. 
 
6.3 
Exclusion Criteria  
Patients meeting any of the following exclusion criteria are not eligible to enroll in this study: 
1. Has received selinexor or another XPO1 inhibitor in a previous line of therapy 
2. Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, 
uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with 
study procedures. 
3. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 
1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a 
controlled infection within 1 week prior to C1D1 are acceptable.  
4. Known intolerance, hypersensitivity, or contraindication to glucocorticoids. 
5. Pregnant or breastfeeding females. 
6. Major surgery within 4 weeks prior to C1D1. 
7. Active, unstable cardiovascular function, as indicated by the presence of: 
a) Symptomatic ischemia, or  
b) Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular 
tachycardia on anti-arrhythmics are excluded; patients with first degree atrioventricular 
block or asymptomatic left anterior fascicular block/right bundle branch block will not 
be excluded), or 
c) Congestive heart failure of New York Heart Association Class ≥3 or known left 
ventricular ejection fraction <40%, or 
d) Myocardial infarction within 3 months prior to C1D1. 
8. Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B 
has been given for >8 weeks and viral load is <100 IU/ml prior to first dose of trial treatment. 
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Subjects with untreated hepatitis C virus (HCV) are allowed. Subjects with Human 
Immunodeficiency Virus (HIV) who have CD4+ T-cell counts ≥ 350 cells/µL and no history 
of AIDS-defining opportunistic infections in the last year are allowed. 
9. Any active gastrointestinal dysfunction interfering with the patient’s ability to swallow 
tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study 
treatment, including prior gastric bypass or bowel resection procedures. 
10. Inability or unwillingness to take supportive medications such as anti-nausea and 
anti-anorexia agents as recommended by the NCCN CPGO for antiemesis and 
anorexia/cachexia (palliative care). 
11. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of 
the Investigator, could interfere with treatment, compliance, or the ability to give informed 
consent.  
12. Contraindication to any of the required concomitant drugs or supportive treatments. 
13. Patients unwilling or unable to comply with the protocol, including providing 24-hour urine 
samples for urine protein electrophoresis at the required time points. 
 
 
 
7 
STUDY TREATMENTS AND TREATMENT ASSIGNMENT 
7.1 
Treatments Administered 
7.1.1 
Study Treatments 
The following study treatment(s) will be used in this study: 
Selinexor: Provided in either of two formulations (both coated, immediate-release tablets for oral 
administration): (a) 20 mg tablets in wallet-sized blister packs. Each blister pack has 
12 tablets(see IST Pharmacy Manual for more information). Patients will be given a supply of 
selinexor for nonclinic dosing days. 
Selinexor will be provided as tablets for oral administration in blister packs (see IST Pharmacy 
Manual for more information). Selinexor tablets will contain 20 mg of the active pharmaceutical 
ingredient (API).  
Study treatments must be dispensed only by a pharmacist or appropriately qualified staff. Study 
treatments are to be dispensed only to patients enrolled in this study. 
 
Pomalidomide: Patients in the SPd Arm will receive a 21-day supply of pomalidomide 4 mg oral 
capsules for each 28-day treatment cycle. 
 
Daratumumab: Patients in the SDd Arm will receive daratumumab subcutaneous injections, (QW 
for Cycles 1 and 2; every 2 weeks for Cycles 3-6; and every 4 weeks for Cycles > 6) as indicated 
in the Darzalex™ (daratumumab) package insert. Daratumumab will be administered by trained 
staff in the clinic only. 
 
Carfilzomib: Patients in the SKd Arm will receive carfilzomib IV infusions (QW on Days 1, 8, 
and 15 of each 28-day cycle). Carfilzomib will be administered by trained staff in the clinic only. 
 
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7.2 
Study Treatment Labeling and Storage 
7.2.1 
Labeling 
All labels will include conditions for storage, lot number, and other information required by the 
Food and Drug Administration (FDA), International Council for Harmonisation (ICH), and/or 
Annex 13, and all local regulations for investigational medications. 
 
7.2.2 
Storage 
Refer to the IST Pharmacy Manual for selinexor storage.  
Pomalidomide, carfilzomib and daratumumab should be stored as described in the prescribing 
information. 
7.3 
Study Treatment Dosing and Administration 
7.3.1 
Dispensing Directions 
Dispensing instructions for selinexor will be provided in the IST Pharmacy Manual. 
For doses of oral selinexor to be taken on nonclinic days, patients will be provided with an 
adequate supply of selinexor for self-administration at home until at least their next scheduled 
study visit. Patients will be provided with a take home diary to complete on home dosing days; 
the patient diary will be reviewed at each clinic visit. 
7.3.2 
Dosing Information 
 Selinexor 
Refer to the IST Pharmacy Manual for details of selinexor formulation, preparation, and 
administration. 
Selinexor tablets should be taken orally with at least 120 mL (4 ounces) of water at approximately 
the same time each day. It can be taken with or without food. Selinexor tablets should be 
swallowed whole (not crushed) to prevent an increased risk of dermatologic toxicity if the powder 
comes in contact with skin. 
For doses of selinexor that are to be taken on nonclinic days, the patient will be provided with 
selinexor by the site pharmacy and selinexor may be self-administered by the patient on an 
outpatient basis. 
 Pomalidomide, Carfilzomib and Daratumumab 
For details of pomalidomide, carfilzomib and daratumumab formulation, preparation, and 
administration, please refer to the full prescribing information for each respective agent 
Carfilzomib and daratumumab will only be administered by qualified site personnel during clinic 
visits in accordance with the prescribing information for carfilzomib and daratumumab 
respectively (in the appropriate local language). 
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7.3.3 
Dose Sequence and Timing for Combination Treatments 
Each study treatment dose can be given at the same time or in any order.  
7.4 
Method of Assigning Patients to Treatment Groups 
Patients will be assigned to treatment arms 1, 2 or 3 by investigator’s choice following 
completion of screening assessments including MyDST testing. 
7.5 
Blinding 
Not applicable, this is an open-label study. 
7.6 
Dose Schedules for Evaluation 
The following dose schedule(s) will be evaluated: 
See Section 7.8 for dose modifications. 
7.6.1 
Selinexor/Pomalidomide/Dexamethasone Arm (1) 
The dose schedule for the selinexor/pomalidomide/dexamethasone Arm (4-week [28-day] cycle) 
is provided in Table 2 Schedule of Study Activities and Assessments – ARM 2(SDd) 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area 
(BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Symptom-directed 
PE 
 
 
 
Perform if clinically indicated) 
 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 43 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory 
Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with 
differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum 
chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     LDH, CRP, TSH, 
PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
     applicable)i 
X 
 
 
 
 
 
X 
 
X 
(even  
cycles 
only) 
 
X 
 
Dose Administration 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 
15) 
X 
X 
(day 8, 
15) 
 
 
     Daratumumab 
(SQ/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
(day 15.   
Stop this 
dose at 
cycle 7+) 
 
 
     Dexamethasone 
(PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum 
protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
UPEP (24-hr urine) and 
urine protein 
immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative 
Immunoglubilin levels 
(IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 44 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
Plasmacytoma 
assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow 
aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core 
biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events 
recording 
 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
 
Continuous (Only SAEs related to study procedures during screening.   
Report until 30 days after last dose of  protocol required therapies) 
 
Concomitant 
medication recording 
 
Continuous 
 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
Collection of 
information regarding 
antineoplastic therapy 
used after EoT 
 
 
 
 
 
 
 
 
 
 
 
X 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: 
electrocardiogram; ECOG: Eastern Cooperative Oncology Group; EoT: end of treatment; hCG: human chorionic gonadotropin; 
ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating 
hormone>. 
u 
Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window 
and are done prior to signing the ICF. 
v 
After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for 
patients who have not progressed to assess durability of response. If MM evaluations cannot be performed, at a minimum, 
contact will be made to the patient (or the patient’s family) to assess the survival status, status of the patient’s MM, and 
overall medical condition of the patient and collect information on any antineoplastic therapies used after End of 
Treatment (see Section 8.5.3). These procedures should only be performed for subjects who have not had disease 
progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to the patient (or the 
patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any 
antineoplastic therapies utilized since last contact. 
w 
Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust 
supportive care as appropriate. The contact with the patient should take place on Day 3 following the Cycle 1 Day 1 
selinexor dosing. 
x 
ICF must be signed before any study-specific procedures are performed. 
y 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a dose of 
selinexor >70 mg/m2. 
z 
Patients must rest for at least 5 minutes prior to the ECG recording. 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 45 of 105 
Confidential 
aa 
Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and 
assessed on the same arm throughout the study. Vital signs do not need to be repeated if they are performed as part of the 
physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
bb Details for clinical laboratory tests are provided in Table .   
cc For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first 
dose of study treatment. Pregnancy testing (serum hCG or urine) is also required for females of childbearing potential prior 
to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy test must be 
documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be 
performed as clinically indicated during the study. 
dd Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are 
the responsibility of the study Sponsor-Investigator.  
ee 
Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and 
serum FLC assay on C1D1 and measurements must be taken either on Day -1 or pre-dose on C1D1 
ff Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT 
may be used instead. Bone lesions seen at Screening should be re-assessed during the study using the same imaging 
modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as determined by 
the Investigator. 
gg If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on 
Day 1 of each cycle and at the EoT visit. 
hh Bone marrow samples 
a. 
Aspirates at Screening for: 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive 
Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow Cytometry, both validated at a detection capacity of 
10-5 
ii After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein immunofixation, 
UPEP (24 hr.) with urine protein immunofixation, serum FLC, and quantitative Ig levels (and bone marrow aspirate and 
physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) will be performed every 
3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, (and for patients who 
had PD and are therefore not followed for response), contact will be made to the patient (or the patient’s family) annually 
for 2 years to inquire about the patient’s survival, MM status, general health, and information on any antineoplastic 
therapies utilized since End of Treatment. 
jj 
Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any 
study-related procedures (including discussions with medical personnel and other study-related evaluations). 
kk SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs 
must be submitted to KPT twice per year. See required template in Appendix 2  For information about cross-reported 
SUSARs from KPT’s CSTs, see memo in Appendix 3. 
ll 
Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies 
for managing potential nausea and appetite changes experienced with selinexor. This may be completed between within the 
screening period for the study and prior to administration of study treatment on C1D1. The nutritional consultation can be 
done by a study investigator or nurse and can be done on a phone call. 
mm Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
nn These procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM 
aspirate and BMBX will be performed at baseline, then as applicable based on baseline results for response assessment 
through the trial.  
 
 
 
 
 
 
 
 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 46 of 105 
Confidential 
Table 3 Schedule of Study Activities and Assessments – ARM 3 (SKd) 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area 
(BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Symptom-directed 
PE 
 
 
 
Perform if clinically indicated) 
 
 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory 
Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with 
differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum 
chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     LDH, CRP, TSH, 
PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
     applicable)i 
X 
 
 
 
 
 
X 
 
X 
(even  
cycles 
only) 
 
X 
 
Dose Administration 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 
15) 
X 
X 
(day 8, 
15) 
 
 
     Carfilzomib 
(SQ/IV) 
 
X 
 
X 
X 
 
X 
X 
X 
X 
 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 47 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
(day 8, 
15) 
(day 8, 
15) 
     Dexamethasone 
(PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum 
protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
UPEP (24-hr urine) and 
urine protein 
immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative 
Immunoglubilin levels 
(IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Plasmacytoma 
assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow 
aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core 
biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events 
recording 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
Continuous (Only SAEs related to study procedures during screening.  
 Report until 30 days after last dose of  protocol required therapies) 
 
Concomitant 
medication recording 
 
Continuous 
 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
Collection of 
information regarding 
antineoplastic therapy 
used after EoT 
 
 
 
 
 
 
 
 
 
 
 
X 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 48 of 105 
Confidential 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: 
electrocardiogram; ECOG: Eastern Cooperative Oncology Group; EoT: end of treatment; hCG: human chorionic gonadotropin; 
ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating 
hormone>. 
u 
Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window 
and are done prior to signing the ICF. 
v 
After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for 
patients who have not progressed to assess durability of response. If MM evaluations cannot be performed, at a minimum, 
contact will be made to the patient (or the patient’s family) to assess the survival status, status of the patient’s MM, and 
overall medical condition of the patient and collect information on any antineoplastic therapies used after End of 
Treatment (see Section 8.5.3). These procedures should only be performed for subjects who have not had disease 
progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to the patient (or the 
patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any 
antineoplastic therapies utilized since last contact. 
w 
Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust 
supportive care as appropriate. The contact with the patient should take place on Day 3 following the Cycle 1 Day 1 
selinexor dosing. 
x 
ICF must be signed before any study-specific procedures are performed. 
y 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a dose of 
selinexor >70 mg/m2. 
z 
Patients must rest for at least 5 minutes prior to the ECG recording. 
aa 
Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and 
assessed on the same arm throughout the study. Vital signs do not need to be repeated if they are performed as part of the 
physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
bb Details for clinical laboratory tests are provided in Table .   
cc For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first 
dose of study treatment. Pregnancy testing (serum hCG or urine) is also required for females of childbearing potential prior 
to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy test must be 
documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be 
performed as clinically indicated during the study. 
dd Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are 
the responsibility of the study Sponsor-Investigator.  
ee 
Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and 
serum FLC assay on C1D1 and measurements must be taken either on Day -1 or pre-dose on C1D1 
ff Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT 
may be used instead. Bone lesions seen at Screening should be re-assessed during the study using the same imaging 
modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as determined by 
the Investigator. 
gg If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on 
Day 1 of each cycle and at the EoT visit. 
hh Bone marrow samples 
a. 
Aspirates at Screening for: 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive 
Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow Cytometry, both validated at a detection capacity of 
10-5 
ii After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein immunofixation, 
UPEP (24 hr.) with urine protein immunofixation, serum FLC, and quantitative Ig levels (and bone marrow aspirate and 
physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) will be performed every 
3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, (and for patients who 
had PD and are therefore not followed for response), contact will be made to the patient (or the patient’s family) annually 
for 2 years to inquire about the patient’s survival, MM status, general health, and information on any antineoplastic 
therapies utilized since End of Treatment. 
jj 
Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any 
study-related procedures (including discussions with medical personnel and other study-related evaluations). 
kk SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs 
must be submitted to KPT twice per year. See required template in Appendix 2  For information about cross-reported 
SUSARs from KPT’s CSTs, see memo in Appendix 3. 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 49 of 105 
Confidential 
ll 
Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies 
for managing potential nausea and appetite changes experienced with selinexor. This may be completed between within the 
screening period for the study and prior to administration of study treatment on C1D1. The nutritional consultation can be 
done by a study investigator or nurse and can be done on a phone call. 
mm Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
nn These procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM 
aspirate and BMBX will be performed at baseline, then as applicable based on baseline results for response assessment 
through the trial.  
 
 
 
 
 
 
 
 
 
 
 
 
. 
 selinexor will be given as a 60 mg dose on Days 1, 8, 15 of each 28-day cycle. 
 pomalidomide will be given at a dose of 4 mg on Days 1-21 of each 28-day cycle. 
 dexamethasone will be given at a dose of 40 mg on days 1, 8, 15 of each 28-day cycle. 
7.6.2 
Selinexor/Daratumumab/Dexamethasone Arm (2) 
The dose schedule for the selinexor/daratumumab/dexamethasone Arm (4-week [28-day] cycle) 
is provided in Table 2 Schedule of Study Activities and Assessments – ARM 2(SDd) 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 50 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area 
(BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Symptom-directed 
PE 
 
 
 
Perform if clinically indicated) 
 
 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory 
Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with 
differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum 
chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     LDH, CRP, TSH, 
PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
     applicable)i 
X 
 
 
 
 
 
X 
 
X 
(even  
cycles 
only) 
 
X 
 
Dose Administration 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 
15) 
X 
X 
(day 8, 
15) 
 
 
     Daratumumab 
(SQ/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
(day 15.   
Stop this 
dose at 
cycle 7+) 
 
 
     Dexamethasone 
(PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum 
protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 51 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
UPEP (24-hr urine) and 
urine protein 
immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative 
Immunoglubilin levels 
(IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Plasmacytoma 
assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow 
aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core 
biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events 
recording 
 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
 
Continuous (Only SAEs related to study procedures during screening.   
Report until 30 days after last dose of  protocol required therapies) 
 
Concomitant 
medication recording 
 
Continuous 
 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
Collection of 
information regarding 
antineoplastic therapy 
used after EoT 
 
 
 
 
 
 
 
 
 
 
 
X 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: 
electrocardiogram; ECOG: Eastern Cooperative Oncology Group; EoT: end of treatment; hCG: human chorionic gonadotropin; 
ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating 
hormone>. 
oo Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window 
and are done prior to signing the ICF. 
pp After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for 
patients who have not progressed to assess durability of response. If MM evaluations cannot be performed, at a minimum, 
contact will be made to the patient (or the patient’s family) to assess the survival status, status of the patient’s MM, and 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 52 of 105 
Confidential 
overall medical condition of the patient and collect information on any antineoplastic therapies used after End of 
Treatment (see Section 8.5.3). These procedures should only be performed for subjects who have not had disease 
progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to the patient (or the 
patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any 
antineoplastic therapies utilized since last contact. 
qq Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust 
supportive care as appropriate. The contact with the patient should take place on Day 3 following the Cycle 1 Day 1 
selinexor dosing. 
rr 
ICF must be signed before any study-specific procedures are performed. 
ss 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a dose of 
selinexor >70 mg/m2. 
tt 
Patients must rest for at least 5 minutes prior to the ECG recording. 
uu Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and 
assessed on the same arm throughout the study. Vital signs do not need to be repeated if they are performed as part of the 
physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
vv Details for clinical laboratory tests are provided in Table .   
ww For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first 
dose of study treatment. Pregnancy testing (serum hCG or urine) is also required for females of childbearing potential prior 
to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy test must be 
documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be 
performed as clinically indicated during the study. 
xx Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are 
the responsibility of the study Sponsor-Investigator.  
yy Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and 
serum FLC assay on C1D1 and measurements must be taken either on Day -1 or pre-dose on C1D1 
zz Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT 
may be used instead. Bone lesions seen at Screening should be re-assessed during the study using the same imaging 
modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as determined by 
the Investigator. 
aaa If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on 
Day 1 of each cycle and at the EoT visit. 
bbb Bone marrow samples 
a. 
Aspirates at Screening for: 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive 
Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow Cytometry, both validated at a detection capacity of 
10-5 
ccc After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein immunofixation, 
UPEP (24 hr.) with urine protein immunofixation, serum FLC, and quantitative Ig levels (and bone marrow aspirate and 
physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) will be performed every 
3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, (and for patients who 
had PD and are therefore not followed for response), contact will be made to the patient (or the patient’s family) annually 
for 2 years to inquire about the patient’s survival, MM status, general health, and information on any antineoplastic 
therapies utilized since End of Treatment. 
ddd Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any 
study-related procedures (including discussions with medical personnel and other study-related evaluations). 
eee SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs 
must be submitted to KPT twice per year. See required template in Appendix 2  For information about cross-reported 
SUSARs from KPT’s CSTs, see memo in Appendix 3. 
fff Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies 
for managing potential nausea and appetite changes experienced with selinexor. This may be completed between within the 
screening period for the study and prior to administration of study treatment on C1D1. The nutritional consultation can be 
done by a study investigator or nurse and can be done on a phone call. 
ggg Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
hhh These procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM 
aspirate and BMBX will be performed at baseline, then as applicable based on baseline results for response assessment 
through the trial.  
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 53 of 105 
Confidential 
 
 
 
 
 
 
 
 
 
Table 3 Schedule of Study Activities and Assessments – ARM 3 (SKd) 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area 
(BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Symptom-directed 
PE 
 
 
 
Perform if clinically indicated) 
 
 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory 
Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with 
differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum 
chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 54 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
     LDH, CRP, TSH, 
PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
     applicable)i 
X 
 
 
 
 
 
X 
 
X 
(even  
cycles 
only) 
 
X 
 
Dose Administration 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 
15) 
X 
X 
(day 8, 
15) 
 
 
     Carfilzomib 
(SQ/IV) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 
15) 
X 
X 
(day 8, 
15) 
 
 
     Dexamethasone 
(PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum 
protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
UPEP (24-hr urine) and 
urine protein 
immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative 
Immunoglubilin levels 
(IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Plasmacytoma 
assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow 
aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core 
biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events 
recording 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
Continuous (Only SAEs related to study procedures during screening.  
 Report until 30 days after last dose of  protocol required therapies) 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 55 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
Concomitant 
medication recording 
 
Continuous 
 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
Collection of 
information regarding 
antineoplastic therapy 
used after EoT 
 
 
 
 
 
 
 
 
 
 
 
X 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: 
electrocardiogram; ECOG: Eastern Cooperative Oncology Group; EoT: end of treatment; hCG: human chorionic gonadotropin; 
ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating 
hormone>. 
oo Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window 
and are done prior to signing the ICF. 
pp After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for 
patients who have not progressed to assess durability of response. If MM evaluations cannot be performed, at a minimum, 
contact will be made to the patient (or the patient’s family) to assess the survival status, status of the patient’s MM, and 
overall medical condition of the patient and collect information on any antineoplastic therapies used after End of 
Treatment (see Section 8.5.3). These procedures should only be performed for subjects who have not had disease 
progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to the patient (or the 
patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any 
antineoplastic therapies utilized since last contact. 
qq Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust 
supportive care as appropriate. The contact with the patient should take place on Day 3 following the Cycle 1 Day 1 
selinexor dosing. 
rr 
ICF must be signed before any study-specific procedures are performed. 
ss 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a dose of 
selinexor >70 mg/m2. 
tt 
Patients must rest for at least 5 minutes prior to the ECG recording. 
uu Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and 
assessed on the same arm throughout the study. Vital signs do not need to be repeated if they are performed as part of the 
physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
vv Details for clinical laboratory tests are provided in Table .   
ww For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first 
dose of study treatment. Pregnancy testing (serum hCG or urine) is also required for females of childbearing potential prior 
to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy test must be 
documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be 
performed as clinically indicated during the study. 
xx Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are 
the responsibility of the study Sponsor-Investigator.  
yy Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and 
serum FLC assay on C1D1 and measurements must be taken either on Day -1 or pre-dose on C1D1 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 56 of 105 
Confidential 
zz Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT 
may be used instead. Bone lesions seen at Screening should be re-assessed during the study using the same imaging 
modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as determined by 
the Investigator. 
aaa If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on 
Day 1 of each cycle and at the EoT visit. 
bbb Bone marrow samples 
a. 
Aspirates at Screening for: 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive 
Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow Cytometry, both validated at a detection capacity of 
10-5 
ccc After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein immunofixation, 
UPEP (24 hr.) with urine protein immunofixation, serum FLC, and quantitative Ig levels (and bone marrow aspirate and 
physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) will be performed every 
3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, (and for patients who 
had PD and are therefore not followed for response), contact will be made to the patient (or the patient’s family) annually 
for 2 years to inquire about the patient’s survival, MM status, general health, and information on any antineoplastic 
therapies utilized since End of Treatment. 
ddd Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any 
study-related procedures (including discussions with medical personnel and other study-related evaluations). 
eee SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs 
must be submitted to KPT twice per year. See required template in Appendix 2  For information about cross-reported 
SUSARs from KPT’s CSTs, see memo in Appendix 3. 
fff Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies 
for managing potential nausea and appetite changes experienced with selinexor. This may be completed between within the 
screening period for the study and prior to administration of study treatment on C1D1. The nutritional consultation can be 
done by a study investigator or nurse and can be done on a phone call. 
ggg Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
hhh These procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM 
aspirate and BMBX will be performed at baseline, then as applicable based on baseline results for response assessment 
through the trial.  
 
 
 
 
 
 
 
 
 
 
 
 
. 
 selinexor will be given as a 80 mg dose on Days 1, 8, 15 of each 28-day cycle. 
 daratumumab will be given at a dose of 1,800mg/30,000 units (may be substituted with 
IV Dara, if directed by Investigator) on Days 1, 8, 15, 22 in cycle 1 and 2, Days 1, 15 in 
cycles 3-6 and Day 1 of cycles greater than 6 of 28-day cycles. 
 dexamethasone will be given at a dose of 40 mg on days 1, 8, 15, 22 of each 28-day cycle. 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 57 of 105 
Confidential 
7.6.3 
Selinexor/Carfilzomib/Dexamethasone Arm (3) 
The dose schedule for the selinexor/carfilzomib/dexamethasone Arm (4-week [28-day] cycle) is 
provided in Table 2 
Schedule of Study Activities and Assessments – ARM 2(SDd) 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area 
(BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Symptom-directed 
PE 
 
 
 
Perform if clinically indicated) 
 
 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory 
Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with 
differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum 
chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     LDH, CRP, TSH, 
PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
     applicable)i 
X 
 
 
 
 
 
X 
 
X 
(even  
cycles 
only) 
 
X 
 
Dose Administration 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X 
X 
X 
 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 58 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
(day 8, 
15) 
(day 8, 
15) 
     Daratumumab 
(SQ/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
(day 15.   
Stop this 
dose at 
cycle 7+) 
 
 
     Dexamethasone 
(PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum 
protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
UPEP (24-hr urine) and 
urine protein 
immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative 
Immunoglubilin levels 
(IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Plasmacytoma 
assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow 
aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core 
biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events 
recording 
 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
 
Continuous (Only SAEs related to study procedures during screening.   
Report until 30 days after last dose of  protocol required therapies) 
 
Concomitant 
medication recording 
 
Continuous 
 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
Collection of 
information regarding 
 
 
 
 
 
 
 
 
 
 
 
X 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 59 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
antineoplastic therapy 
used after EoT 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: 
electrocardiogram; ECOG: Eastern Cooperative Oncology Group; EoT: end of treatment; hCG: human chorionic gonadotropin; 
ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating 
hormone>. 
iii 
Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window 
and are done prior to signing the ICF. 
jjj 
After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for 
patients who have not progressed to assess durability of response. If MM evaluations cannot be performed, at a minimum, 
contact will be made to the patient (or the patient’s family) to assess the survival status, status of the patient’s MM, and 
overall medical condition of the patient and collect information on any antineoplastic therapies used after End of 
Treatment (see Section 8.5.3). These procedures should only be performed for subjects who have not had disease 
progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to the patient (or the 
patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any 
antineoplastic therapies utilized since last contact. 
kkk Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust 
supportive care as appropriate. The contact with the patient should take place on Day 3 following the Cycle 1 Day 1 
selinexor dosing. 
lll 
ICF must be signed before any study-specific procedures are performed. 
mmm 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a 
dose of selinexor >70 mg/m2. 
nnn Patients must rest for at least 5 minutes prior to the ECG recording. 
ooo Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and 
assessed on the same arm throughout the study. Vital signs do not need to be repeated if they are performed as part of the 
physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
ppp Details for clinical laboratory tests are provided in Table .   
qqq For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first 
dose of study treatment. Pregnancy testing (serum hCG or urine) is also required for females of childbearing potential prior 
to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy test must be 
documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be 
performed as clinically indicated during the study. 
rrr Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are 
the responsibility of the study Sponsor-Investigator.  
sss Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and 
serum FLC assay on C1D1 and measurements must be taken either on Day -1 or pre-dose on C1D1 
ttt Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT 
may be used instead. Bone lesions seen at Screening should be re-assessed during the study using the same imaging 
modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as determined by 
the Investigator. 
uuu If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on 
Day 1 of each cycle and at the EoT visit. 
vvv Bone marrow samples 
a. 
Aspirates at Screening for: 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 60 of 105 
Confidential 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive 
Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow Cytometry, both validated at a detection capacity of 
10-5 
www 
After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein 
immunofixation, UPEP (24 hr.) with urine protein immunofixation, serum FLC, and quantitative Ig levels (and bone 
marrow aspirate and physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) 
will be performed every 3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, 
(and for patients who had PD and are therefore not followed for response), contact will be made to the patient (or the 
patient’s family) annually for 2 years to inquire about the patient’s survival, MM status, general health, and information 
on any antineoplastic therapies utilized since End of Treatment. 
xxx Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any 
study-related procedures (including discussions with medical personnel and other study-related evaluations). 
yyy SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs 
must be submitted to KPT twice per year. See required template in Appendix 2  For information about cross-reported 
SUSARs from KPT’s CSTs, see memo in Appendix 3. 
zzz Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies 
for managing potential nausea and appetite changes experienced with selinexor. This may be completed between within the 
screening period for the study and prior to administration of study treatment on C1D1. The nutritional consultation can be 
done by a study investigator or nurse and can be done on a phone call. 
aaaa Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
bbbbThese procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM 
aspirate and BMBX will be performed at baseline, then as applicable based on baseline results for response assessment 
through the trial.  
 
 
 
 
 
 
 
 
 
Table 3 Schedule of Study Activities and Assessments – ARM 3 (SKd) 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
ICFd 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Patient History 
 
 
 
 
 
 
 
 
 
 
 
 
     Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 61 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
     Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Height  
X 
 
 
 
 
 
 
 
 
 
 
 
     Weight 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Body Surface Area 
(BSA)e 
X 
 
 
 
 
 
 
 
 
 
 
 
     Vital signsg 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     ECOG 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
     Physical Exam 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
     Symptom-directed 
PE 
 
 
 
Perform if clinically indicated) 
 
 
     12-lead ECGf 
X 
Perform if clinically indicated) 
X 
 
     Echocardiogram or    
     MUGAt 
 
Perform if clinically indicated) 
 
 
Laboratory 
Assessments 
 
 
 
 
 
 
 
 
 
 
 
 
     Urinalysish 
X 
 
 
 
 
 
 
 
 
 
X 
 
     CBC with 
differentialh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     Complete serum 
chemistryh 
X 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
     LDH, CRP, TSH, 
PT/INR, PTT 
X 
 
 
 
 
 
 
 
 
 
X 
 
     Pregnancy test (if   
     applicable)i 
X 
 
 
 
 
 
X 
 
X 
(even  
cycles 
only) 
 
X 
 
Dose Administration 
     Selinexor (PO) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 
15) 
X 
X 
(day 8, 
15) 
 
 
     Carfilzomib 
(SQ/IV) 
 
X 
 
X 
X 
 
X 
X 
(day 8, 
15) 
X 
X 
(day 8, 
15) 
 
 
     Dexamethasone 
(PO/IV) 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Multiple Myeloma Disease Assessments 
SPEP and serum 
protein 
immunofixationk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 62 of 105 
Confidential 
Activity/Assessment  
Screen
inga 
Cycle 1 
Cycle 2 
Cycles ≥3 
End-of-
Treatme
nt  
(EoT) 
Visit 
Durability 
of 
Response 
(Every 3 
months) 
and 
Survival  
Follow-upb 
(Yearly) 
Day -
28 to 
Day 1 
Day  
1  
Day 
3 
Phon
e 
Callc 
Da
y 8 
Da
y 
15 
Da
y 
22 
Day 1 
Day 8, 
15, 22 
Day 1 
Day 8, 
15, 22 
≤14 Days  
Post-Last 
Dose 
-1  
days 
+ 1  
day 
± 1 
da
y 
± 1 
day 
± 1 
day 
± 2 days 
± 2 
days 
± 2 days ± 2 days 
 
± 14 days 
UPEP (24-hr urine) and 
urine protein 
immunofixationk,o,t 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Quantitative 
Immunoglubilin levels 
(IgG, IgA, IgM)k,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Serum FLCk,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
β2-microglobulin 
X 
 
 
 
 
 
 
 
 
 
X 
 
Skeletal surveyl,o 
X 
 
 
 
 
 
 
 
 
 
X 
 
Plasmacytoma 
assessmentm,o 
X 
X 
 
 
 
 
X 
 
X 
 
X 
 
Bone marrow 
aspiraten,t 
X 
 
 
 
 
 
X 
 
X 
 
 
 
Bone marrow core 
biopsyt 
X 
 
 
 
 
 
 
 
 
 
 
 
HR-QoLq 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
Adverse events 
recording 
 
Continuous (until 30 days after last dose of  protocol required therapies) 
 
SAE reportingq 
Continuous (Only SAEs related to study procedures during screening.  
 Report until 30 days after last dose of  protocol required therapies) 
 
Concomitant 
medication recording 
 
Continuous 
 
Nutritional consultation 
Perform if clinically indicated 
 
 
Contact subject 
 
 
Xc 
 
 
 
 
 
 
 
 
 
Collection of 
information regarding 
antineoplastic therapy 
used after EoT 
 
 
 
 
 
 
 
 
 
 
 
X 
Survival Follow Up 
 
 
 
 
 
 
 
 
 
 
 
X 
 
AE: adverse event; BSA: body surface area; CBC: complete blood count; C1D1: Cycle 1 Day 1; D: day; ECG: 
electrocardiogram; ECOG: Eastern Cooperative Oncology Group; EoT: end of treatment; hCG: human chorionic gonadotropin; 
ICF: informed consent form; HR-QoL: health-related quality of life; <MUGA: multiple gated acquisition> PDn: 
pharmacodynamics; PE: physical examination; PK: pharmacokinetics; SAE: serious adverse event;<TSH: thyroid-stimulating 
hormone>. 
iii 
Procedures that are performed as part of standard of care should not be repeated if they are within the Screening window 
and are done prior to signing the ICF. 
jjj 
After End of Treatment, if feasible and clinically indicated, MM evaluations should be performed every 3 months for 
patients who have not progressed to assess durability of response. If MM evaluations cannot be performed, at a minimum, 
contact will be made to the patient (or the patient’s family) to assess the survival status, status of the patient’s MM, and 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 63 of 105 
Confidential 
overall medical condition of the patient and collect information on any antineoplastic therapies used after End of 
Treatment (see Section 8.5.3). These procedures should only be performed for subjects who have not had disease 
progression. Otherwise, after end of treatment visit, a telephone call, email or visit will be made to the patient (or the 
patient’s family) annually, for two years, to inquire about the patient’s MM status, general health, and information on any 
antineoplastic therapies utilized since last contact. 
kkk Contact with patient to evaluate supportive care medications, concomitant medications, and adverse events, and to adjust 
supportive care as appropriate. The contact with the patient should take place on Day 3 following the Cycle 1 Day 1 
selinexor dosing. 
lll 
ICF must be signed before any study-specific procedures are performed. 
mmm 
BSA should be calculated during Screening and as needed during the study to make sure that no patient receives a 
dose of selinexor >70 mg/m2. 
nnn Patients must rest for at least 5 minutes prior to the ECG recording. 
ooo Blood pressure and pulse rate should be measured after the patient has been in a supine or sitting position for 5 minutes and 
assessed on the same arm throughout the study. Vital signs do not need to be repeated if they are performed as part of the 
physical examination. Vital signs should be assessed predose on the scheduled visit day, if possible. 
ppp Details for clinical laboratory tests are provided in Table .   
qqq For females of childbearing potential; negative serum hCG pregnancy test must be obtained within 3 days before the first 
dose of study treatment. Pregnancy testing (serum hCG or urine) is also required for females of childbearing potential prior 
to dosing on Day 1 of Cycle 2 and even numbered cycles ≥3 while on treatment (a negative pregnancy test must be 
documented prior to administration of study drug) and at the EoT Visit (serum hCG). Pregnancy testing may also be 
performed as clinically indicated during the study. 
rrr Generally, with some exceptions, the storage, processing and analysis of samples for correlative studies in KPT ISTs are 
the responsibility of the study Sponsor-Investigator.  
sss Response criteria include SPEP, UPEP (24-hr urine), serum and urine protein immunofixation, quantitative Ig levels, and 
serum FLC assay on C1D1 and measurements must be taken either on Day -1 or pre-dose on C1D1 
ttt Skeletal survey to be performed using X-rays per institutional guidelines. If clinically appropriate, MRI, CT, or PET/CT 
may be used instead. Bone lesions seen at Screening should be re-assessed during the study using the same imaging 
modality that was used at Screening. Repeat scans should be done at a clinically appropriate frequency, as determined by 
the Investigator. 
uuu If plasmacytomas are detected at baseline by physical examination, they should be re-assessed during the physical exam on 
Day 1 of each cycle and at the EoT visit. 
vvv Bone marrow samples 
a. 
Aspirates at Screening for: 
i. 
My-DST Assessment 
ii. 
FISH analysis to confirm diagnosis and classify MM sub-type (per IMWG), 
iii. 
Baseline MRD analysis  
b. 
At time of response, an aspirate and core biopsy are needed to: 
i. 
Core biopsy to confirm CR and sCR, (per IMWG) 
ii. 
Aspirate for MRD analysis for patients who achieve CR or sCR, MRD will be assessed by either Adaptive 
Biotech’s Clonoseq NGS platform (preferred) or Mayo Flow Cytometry, both validated at a detection capacity of 
10-5 
www 
After End of Treatment, if possible, for patients whose disease is not progressing, SPEP with serum protein 
immunofixation, UPEP (24 hr.) with urine protein immunofixation, serum FLC, and quantitative Ig levels (and bone 
marrow aspirate and physical examinations and imaging for bone lesions and plasmacytomas, if clinically appropriate) 
will be performed every 3 months for 1 year to assess DOR.  See Section 6.14.5.  If these assessments cannot be performed, 
(and for patients who had PD and are therefore not followed for response), contact will be made to the patient (or the 
patient’s family) annually for 2 years to inquire about the patient’s survival, MM status, general health, and information 
on any antineoplastic therapies utilized since End of Treatment. 
xxx Patient should complete all of the HR-QoL instruments (ie, EORTC QLQ-C30 and QLQ-MY20) on these visits before any 
study-related procedures (including discussions with medical personnel and other study-related evaluations). 
yyy SAEs must be reported to KPT within 24 hours of first awareness. See required form in Appendix 1. Line listings of all AEs 
must be submitted to KPT twice per year. See required template in Appendix 2  For information about cross-reported 
SUSARs from KPT’s CSTs, see memo in Appendix 3. 
zzz Patients will be given nutritional consultation, if clinically indicated, to discuss any food recommendations and strategies 
for managing potential nausea and appetite changes experienced with selinexor. This may be completed between within the 
screening period for the study and prior to administration of study treatment on C1D1. The nutritional consultation can be 
done by a study investigator or nurse and can be done on a phone call. 
aaaa Evaluations may be performed on day-1 of cycle 1 if required due to infusion related logistics. 
bbbbThese procedures should be performed per Investigator discretion, as appropriate for response assessment.  UPEP, BM 
aspirate and BMBX will be performed at baseline, then as applicable based on baseline results for response assessment 
through the trial.  
 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 64 of 105 
Confidential 
 
 
 
 
 
 
 
 
 
 
. 
 selinexor will be given as a 80 mg dose on Days 1, 8, 15 of each 28-day cycle. 
 carfilzomib will be given at a dose of 20 mg/m2 on Day 1 of cycle 1 then 56 mg/m2 on 
Days 8, 15 of cycle 1 and Days 1, 8, 15 of each subsequent 28-day cycle. 
 dexamethasone will be given at a dose of 40 mg on days 1, 8, 15, 22 of each 28-day cycle. 
 
7.7 
Missed or Vomited Doses 
7.7.1 
Missed Doses of Selinexor 
Missed doses should be managed as follows:  
 If a dose was missed, the schedule of that week should be altered to accommodate two doses 
in that week with at least 36 hours between 2 consecutive doses.  
 If a dose must be skipped (eg, due to recommendation of treating physician), the next dose 
will be taken as per schedule. Doses should not be administered less than 36 hours apart and 
all missed and delayed doses should be documented. 
If a patient missed a full 1- or 2-week period of dosing for non-study treatment-related events 
(eg, a required medical procedure or an unanticipated personal emergency), the days missed will 
be replaced. For example, if the patient missed Cycle 2 Day 7 to Cycle 2 Day 14, then the patient 
will start the next dosing on Cycle 2 Day 7 following the break. Similarly, if a patient misses 
Cycle 3 Day 1 to Cycle 3 Day 15, then the patient will start the next dosing on Cycle 3 Day 1.  
 
7.7.2 
Vomited Doses of Selinexor 
If a dose of selinexor is vomited within 1 hour of ingestion, and all intact tablets are seen, it will 
be replaced. If vomiting occurs more than 1 hour after dosing, it will be considered a complete 
dose. 
7.8 
Dose Modifications 
All dose modifications will be captured in the site’s record, as applicable. 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 65 of 105 
Confidential 
7.8.1 
Selinexor Dose Reduction Guidelines 
Dose reductions and/or schedule modifications are allowed in order to optimize the antitumor 
activity and tolerability of selinexor. For some AEs, dose interruption and/or reduction is 
recommended. See Table 2 for pre-specified dose modifications for AEs related to study 
treatment and see Table 3 for dose reduction and interruption recommendations. 
While drug-related major organ toxicities are not prominent, thrombocytopenia and a number of 
constitutional side effects can limit dosing with selinexor. Therefore, patients should also be 
treated with supportive care to reduce toxicities (see Section 7.10.2). In addition, it should be 
noted that the constitutional side effects often attenuate over the first 4 to 6 weeks of dosing.  
The CTCAE v 5.0 is used for grading the severity of AEs; the therapy modifications described 
in Table 3 are applied according to this severity grading. Toxicity will be documented as 
described in Section 9.1.3. If more than 1 type of toxicity occurs concurrently, the most severe 
grade will determine the modification. 
Each dose modification or treatment delay, as well as the reason, must be documented (Table 2 
and Table 3).  
Table 2 summarizes the starting doses (Dose Level 1) and preferred dose modifications (ie, Dose 
Levels -1 through -3) for AEs listed in Table 3Table 3. General supportive care guidelines are 
provided in Section 7.10.1 and Section 7.10.2. 
Table 2 Pre-specified Dose Modifications for AEs Related to Study Treatment 
Selinexor Dose Levela 
Selinexor Dose Schedule 
Dose level 0  
(starting dose) 
80 mg (4 tablets) weekly (Day 1) 
Dose level -1b 
60 mg weekly (Day 1) 
Dose level -2c  
40 mg weekly (Day 1) 
Dose level -3d  
20 mg weekly (Day 1) 
aFor some AEs, dose interruption rather than reduction is recommended. See Table 3 for specific 
recommendations. 
bThis is dose level 0 for Arm 1 
cThis is dose level -1 for Arm 1 
dThis is dose level -2 for Arm 1 
 
 
Table 3 Suggested Supportive Care and Dose Adjustment Guidelines for AEs Related to Selinexor 
Adverse Event 
Occurrence 
Action 
Hematologic Adverse Events 
Thrombocytopenia 
Platelet count 25,000 to less 
than 75,000/mcL 
Any 
 
Reduce selinexor by 1 dose level (see Table 2) 
 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 66 of 105 
Confidential 
Adverse Event 
Occurrence 
Action 
Platelet count 25,000 to less 
than 75,000/mcL with 
concurrent bleeding 
Any 
 
Interrupt selinexor 
 
Restart selinexor at 1 dose level lower after 
bleeding has resolved (see Table 2) 
 
Administer platelet transfusions per clinical 
guidelines 
Platelet count than 
25,000/mcL 
Any 
 
Interrupt selinexor 
 
Monitor until platelet count returns to at least 
50,000/mcL  
 
Restart selinexor at 1 dose level lower (see Table 
2) 
 
Neutropenia 
ANC 0.5 to 1.0 × 109/L 
without fever 
Any 
 
Reduce selinexor by 1 dose level (see Table 2) 
ANC <0.5 × 109/L OR febrile 
neutropenia 
Any 
 
Interrupt selinexor 
 
Monitor until ANC returns to ≥1.0 × 109/L 
 
Restart selinexor at 1 dose level lower (see Table 
2) 
 
Anemia 
Hb <8.0 g/dL 
Any 
 
Reduce selinexor by 1 dose level (see Table 2) 
 
Administer blood transfusions and/or other 
treatments per clinical guidelines 
Life-threatening 
consequences  
Any 
 
Interrupt selinexor 
 
Monitor until Hb returns to ≥8.0 g/dL 
 
Restart selinexor at 1 dose level lower (see Table 
2) 
 
Administer blood transfusions and/or other 
treatments per clinical guidelines 
Nonhematologic Adverse Events 
Hyponatremia 
Sodium ≤130 mmol/L  
Any 
 
Interrupt selinexor, evaluate, and provide 
appropriate supportive care 
 
Monitor until sodium returns to >130 mmol/L 
 
Restart selinexor at 1 dose level lower (see Table 
2) 
Fatigue 
Grade 2 lasting >7 days OR 
Grade 3 
Any 
 
Interrupt selinexor  
 
Monitor until fatigue resolves to Grade 1 or 
baseline 
 
Restart selinexor at 1 dose level lower (see Table 
2) 
Nausea and Vomiting 
Grade 1 or 2 nausea (oral 
intake decreased without 
significant weight loss, 
Any 
 
Maintain selinexor and initiate additional 
anti-nausea medications 
Docusign Envelope ID: 5F5E6533-7054-43A6-969E-E80D7C1A698E

Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 67 of 105 
Confidential 
Adverse Event 
Occurrence 
Action 
dehydration or malnutrition) 
OR  
Grade 1 or 2 vomiting (5 or 
fewer episodes per day) 
Grade 3 nausea (inadequate 
oral caloric or fluid intake)  
OR  
Grade ≥3 vomiting (6 or 
more episodes per day) 
Any 
 
Interrupt selinexor 
 
Monitor until nausea or vomiting has resolved to 
≤Grade 2 or baseline. 
 
Initiate additional anti-nausea medications 
 
Restart selinexor at 1 dose level lower (see Table 
2) 
Diarrhea 
Grade 2 (increase of 4 to 6 
stools per day over baseline)  
First 
 
Maintain selinexor and institute supportive care 
 
Second and 
subsequent 
 
Reduce selinexor by 1 dose level (see Table 2) 
 
Institute supportive care 
Grade ≥3 or higher (increase 
of 7 stools or more per day 
over baseline; hospitalization 
indicated)  
Any 
 
Interrupt selinexor and institute supportive care 
 
Monitor until diarrhea resolves to Grade ≤2 
 
Restart selinexor at 1 dose level lower (see Table 
2) 
Weight Loss and Anorexia 
Weight loss of 10% to <20% 
OR anorexia associated with 
significant weight loss or 
malnutrition 
Any 
 
Interrupt selinexor and institute supportive care 
 
Monitor until weight returns to >90% of baseline 
weight 
 
Restart selinexor at 1 dose level lower (see Table 
2) 
Other Nonhematologic Adverse Events 
Grade 3 or 4 
Any 
 
Interrupt selinexor  
 
Monitor until resolved to ≤Grade 2 
 
Restart selinexor at 1 dose level lower (see Table 
2) 
ANC = absolute neutrophil count; Hb = hemoglobin. 
 
 Selinexor Dose Adjustment in the Setting of Infection 
Patients with active uncontrolled or suspected infections should have treatment withheld until 
the infection has clinically resolved and/or the patient is clinically stable. When ready to resume 
dosing, treatment may continue at the original dose. Missed doses will not be replaced.  Patients 
may continue antibiotics for prolonged periods while re-initiating their treatment at the discretion 
of the Investigator.  
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 Conditions Not Requiring Selinexor Dose Reduction 
The following conditions are exceptions to the dose-modification guidelines. Selinexor does not 
need to be interrupted or reduced in the following cases: 
 Alopecia of any grade 
 Electrolyte or serum analyte (eg, urate) abnormalities that are reversible with standard 
interventions 
 Isolated values of Grade ≥3 alkaline phosphatase. Determination of liver versus bone 
etiology should be made, and evaluation of gamma-glutamyl transferase, 5' nucleotidase, 
or other liver enzymes should be performed. 
7.8.2 
Dose Modifications for Overlapping Toxicities 
Thrombocytopenia and neutropenia are potential overlapping toxicities for selinexor 
with the non-selinexor drug (e.g., bortezomib). If a patient has drug-induced 
thrombocytopenia or neutropenia while receiving the combinations under 
investigation in this study, the Investigator should attempt to determine which drug 
may be responsible and treat appropriately, including dose modifications, as 
necessary. If the cause cannot be attributed to a single drug, suggested management 
strategies for possibly drug-induced thrombocytopenia and neutropenia Grade 3/4 
events are provided below. 
 Thrombocytopenia 
1. Grade 2 - Consider implementing platelet growth factors 
(eltrombopag or romiplostim +/- oprelvekin [IL-11]) and platelet 
transfusions, per institutional guidelines. Monitor platelet counts 
weekly. (See Table 6, under Thrombocytopenia.) 
2. Grades ≥ 3 - Interrupt/adjust selinexor dose as described in Table 
6, under Thrombocytopenia. 
3. Grades ≥ 3 - Interrupt/adjust the dose for the non-selinexor drug as 
described in that product’s approved labeling. 
 
 Neutropenia 
1. Grade 3 without fever – Maintain selinexor dose and consider 
supportive care as described in Table 6, under Neutropenia. 
2. Grade 4 without fever – Reduce selinexor dose by one level. See 
additional supportive care in Table 6, under Neutropenia. 
3. Grades 3/4 with fever – Interrupt selinexor dosing until fever resolves 
and patient is clinically stable. When patient is clinically stable, restart 
selinexor one dose level lower. See additional supportive care in Table 
6, under Neutropenia. 
4. Grades 3/4 – If interrupting selinexor does not resolve the neutropenia, 
consider interrupting/adjusting the dose of the non-selinexor drug as 
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described in that product’s approved labeling. 
The manufacturers of the non-selinexor drugs have provided dose adjustment 
guidelines for managing Grade 3-4 thrombocytopenia that occur during treatment 
with their products in their respective product monograph/labeling. 
These guidelines, together with the recommended dose adjustments for selinexor 
provided in Table 6, should be consulted by the Investigator to manage 
thrombocytopenia associated with study treatments, as needed. 
 
7.8.3 
Carfilzomib Dose Modifications 
Carfilzomib Dose Reduction 
Dose Level 0  
(Starting Dose) 
Carfilzomib IV 56 mg/m2 on days 1,8,15 of a 28-day 
cycle 
Dose Level -1 
Carfilzomib IV 45 mg/m2 on days 1,8,15 of a 28-day 
cycle 
Dose Level -2 
Carfilzomib IV 36 mg/m2 on days 1,8,15 of a 28-day 
cycle 
 
Specific dose adjustment/modification/delay considerations: 
 
Cardiac Toxicity  
Grade 3 or 4, new onset or 
worsening of: 
 
congestive 
heart 
failure; 
 
decreased 
left 
ventricular 
function; 
 or myocardial ischemia  
  Withhold until resolved or returned to baseline.  
  After resolution, restart with 1 dose level reduction 
  If tolerated, the reduced dose may be escalated to the previous dose at the discretion 
of the physician.  
Pulmonary Hypertension  
  Withhold until resolved or returned to baseline.  
  After resolution, restart with 1 dose level reduction 
  If tolerated, the reduced dose may be escalated to the previous dose at the discretion 
of the physician.  
Pulmonary Complications  
 Grade 3 or 4 
  Withhold until resolved or returned to baseline.  
  After resolution, restart with 1 dose level reduction 
  If tolerated, the reduced dose may be escalated to the previous dose at the discretion 
of the physician.  
Renal Toxicity  
 Serum creatinine greater than or 
equal to 2 × baseline, or 
 Creatinine clearance less 
than 15 mL/min, or creatinine 
clearance decreases to less than or 
equal to 50% of baseline, or need 
for hemodialysis 
• Withhold dose and continue monitoring renal function (serum 
creatinine or creatinine clearance) 
• If attributable to Kyprolis, resume when renal function has 
recovered to within 25% of baseline; start at 1 dose level 
reductiona 
• If not attributable to Kyprolis, dosing may be resumed at 
the discretion of the physician 
• For patients on hemodialysis receiving Kyprolis, the dose is to 
be administered after the hemodialysis procedure 
Hepatic Impairment 
Mild 
to 
moderate 
liver 
dysfunction: 
defined 
as 
2 
consecutive values, at least 28 
days apart, of: 
(1) total bilirubin (> 33% 
 
25% dose reduction. 
Dose may be re-escalated if liver function tests return to normal and drug-
induced hepatotoxicity is excluded. 
 
 
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direct) > 1x ULN to < 3x ULN 
OR 
(2) an elevation of AST 
and/or 
ALT 
with 
normal 
bilirubin 
Grade 3 elevation in ALT and/or 
AST (> 5x ULN) 
Grade 3 elevation in total bilirubin 
Drug-induced 
hepatotoxicity 
(attributable to carfilzomib) 
 
 
 
 
 
 
Hold carfilzomib until resolution to baseline. 
Monitor any abnormality weekly. Resume carfilzomib with a 25% dose reduction if 
drug-induced hepatotoxicity is excluded. 
 
 
Hold carfilzomib until resolution to baseline. Monitor total bilirubin and direct 
bilirubin weekly. 
Upon resolution of total bilirubin to normal, resume carfilzomib dosing with a 25% 
dose reduction if drug-induced hepatotoxicity is excluded. 
 
Discontinue carfilzomib 
Posterior 
Reversible 
Encephalopathy 
Syndrome 
(PRES) 
If PRES is suspected, hold carfilzomib. Consider evaluation with neuroradiological 
imaging, specifically MRI, for onset of visual or neurological symptoms suggestive of 
PRES. If PRES is confirmed, permanently discontinue carfilzomib. If the diagnosis of 
PRES is excluded, carfilzomib administration may resume at same dose, if clinically 
appropriate. 
Thrombotic 
Microangiopathy 
(TMA) 
If the diagnosis is suspected, hold carfilzomib and manage per standard of care 
including plasma exchange as clinically appropriate. If TMA is confirmed, permanently 
discontinue carfilzomib. If the diagnosis is excluded, carfilzomib can be restarted. 
 
7.8.4 
Pomalidomide Dose Modifications 
Pomalidomide Dose Reduction 
Dose Level 0  
(Starting Dose) 
Pomalidomide 4 mg oral on days 1-21 of a 28-day cycle 
Dose Level -1 
Pomalidomide 3 mg oral on days 1-21 of a 28-day cycle 
Dose Level -2 
Pomalidomide 2 mg oral on days 1-21 of a 28-day cycle 
 
7.9 
Duration of Treatment and Follow-up 
There is no maximum treatment duration. Patients will continue to receive treatment during the 
study until disease progression (however patients may stay on treatment if they have clinical 
benefit per the Investigator), death, toxicity (i.e., AEs that cannot be managed with medical care), 
or withdrawal from the study.  After completion of treatment patients will be monitored for 
survival and subsequent therapies annually for 2 years. 
7.10 Supportive 
Care, 
Contraception 
Requirements, 
Concomitant 
Medications, and Restrictions 
7.10.1 
Required Anti-emetic Support 
In order to minimize nausea, unless contraindicated, all patients should receive serotonin receptor 
subtype (5-HT3) antagonists (ondansetron 8 mg or equivalent), starting Q8 hours before each 
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dosing and continue 2 -3 times daily for a few days after dosing. In addition to the required 
prophylactic therapy with 5-HT3 antagonists (Section 7.10.1) a second antimetic support for all 
patients receiving selinexor will include planned neurokinin 1 antagonist (eg aprepitant, 
fosaprepitant or rolapitant) or olanzapine 5mg at bedtime.  
Alternative antiemetic agents may be used if the patient does not tolerate or has inadequate 
antiemetic effect with 5-HT3 antagonists or olanzapine. If an NK1 receptor antagonist is needed, 
rolapitant is preferred given that the other agents in this class (aprepritant, fosaprepritant, 
netupitant) may result in drug-drug interactions via inhibition of CYP3A4 which could increase 
selinexor exposures. 
Patients may receive other supportive care, including hydration prophylaxis, antibiotics, as 
appropriate.   
7.10.2 
Recommended Supportive Care for All Patients 
Supportive measures for optimal medical care should be provided to all patients during 
participation in this study.  Additional supportive care per institutional guidelines and/or the 
National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology 
(CPGO) (NCCN CPGO) should be used as clinically indicated at the discretion of the 
Investigator.  
Supportive care guidelines for managing AEs are provided in Table 3. 
7.10.3 
Contraception Requirements 
Patients should not become pregnant or father a child while on this study because the study 
treatments in this study can affect an unborn baby. Women should not breastfeed a baby while 
on this study. It is important that patients understand the need to use birth control while on this 
study.  
Female patients of childbearing potential and fertile male patients must agree to use highly 
effective contraception listed below (ie, results in a low failure rate when used consistently and 
correctly) during the dosing period and for a period of at least 3 months after the end of treatment. 
Highly effective methods include: 
 combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulation: 
o oral 
o intravaginal 
o transdermal 
 progestogen-only hormonal contraception associated with inhibition of ovulation: 
o oral 
o injectable 
o implantable 
 intrauterine device 
 intrauterine hormone-releasing system 
 bilateral tubal occlusion 
 vasectomized partner 
 sexual abstinence 
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Please see Section 9.3.1 for additional safety information related to pregnancy. 
7.10.4 
Concomitant Medication and Treatment 
Concomitant medications include any prescription or over-the-counter preparation, including 
vitamins, dietary supplements, over-the-counter medications, and oral herbal preparations taken 
during the study, from Consent until End of Treatment. Patients may continue their baseline 
medication(s). Any diagnostic, therapeutic, or surgical procedure performed during the study 
period should be recorded, including the dates, description of the procedure(s), and any clinical 
findings, if applicable. 
7.10.5 
Permitted Concomitant Medication  
Patients will receive concomitant medications to treat symptoms, AEs, and intercurrent illnesses 
that are medically necessary as part of standard care. Medications to treat concomitant diseases 
like diabetes, hypertension, etc., are allowed. 
7.10.6 
Prohibited Medications 
Concurrent therapy with palliative radiation is allowable per Investigator direction and 
discretion.  Investigative anticancer therapeutic outside of those included in this study is not 
allowed. Use of any immunosuppressive agents during the study must be confirmed by the 
Sponsor-Investigator. Refer to the full prescribing information for pomalidomide, carfilzomib or 
daratumumab depending on treatment arm for the most current information on prohibited 
concurrent medications. 
7.10.7 
Restrictions for Study Treatment 
 
Restrictions for Selinexor 
Medications:   
There are no restrictions on the use of acetaminophen or acetaminophen-
containing products in combination with selinexor, EXCEPT on days of selinexor 
dosing, when acetaminophen use must not exceed a total daily dose of 1 g. 
Diet: 
There are no dietary restrictions on this study. Patients on selinexor should 
maintain adequate caloric and fluid intake. 
 
 
Restrictions 
for 
pomalidomide, 
daratumumab 
and 
carfilzomib 
Refer to the full prescribing information for pomalidomide, daratumumab or carfilzomib based 
on appropriate corresponding treatment arm for the most current information for restrictions. 
 
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8 
STUDY ASSESSMENTS 
Refer to Schedule of Assessments and Study Schematics 
Table 1 for the timing of all assessments. 
Procedures that are performed as part of standard of care should not be repeated if they are within 
the Screening window and are done prior to signing the ICF. 
8.1 
Informed Consent 
Assessments may not be performed until the patient provides written informed consent (see 
Section 13.6). 
8.2 
Demographic and Baseline Characteristics Assessments 
8.2.1 
Demographics 
Patient demographics (including date of birth, sex, race, ethnicity, and age at the time of consent) 
will be collected. 
8.2.2 
Medical History 
A complete medical history will be obtained from each patient. Medical history will include 
baseline symptoms as well as a detailed history of prior procedures for the patient’s myeloma 
and other prior cancer therapies (ie, chemotherapy, hormonal therapy, immunotherapy, 
biotherapy, radiotherapy, and surgery), including start and end dates, best response, PD during 
or after therapy, as well as discontinuations due to intolerability or toxicity. Smoking history will 
be recorded. A detailed history of disease-specific diagnostic and prognostic testing and test 
results (such as phenotypic and cytogenetic profiles) will be collected.  
Data from standard-of-care procedures will be part of the patient's medical history and may be 
used for study purposes. 
 
8.3 
Efficacy Assessments 
8.3.1 
Multiple Myeloma Disease Assessments 
Patient response will be assessed by the procedures summarized in Table 7 and graded according 
to IMWG (Appendix 5) 
 
 
 
 
 
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Table 7  
Multiple Myeloma Disease-Specific Assessments 
Patients will have their disease assessed by the following procedures per modified IMWG (see Appendix 5). 
Assessments on dosing days should be performed pre-dose. Time points are provided in Table 1. 
Procedure 
Notes 
SPEP with M-spike quantification, and 
serum protein immunofixation 
Per IMWG 
UPEP (24-hour urine for total protein) 
with M-spike quantification and urine 
protein immunofixation 
Per IMWG 
  (Only applicable if directed by MM disease) 
Serum FLC 
Per MWG 
Quantitative immunoglobulin (Ig) levels 
If SPEP is felt to be unreliable for routine M-protein measurement, then 
quantitative Ig levels by nephelometry or turbidometry are acceptable. For 
IgA myeloma, by quantitative IgA. 
β2-microglobulin 
For MM staging, not for assessing response 
Skeletal survey 
A skeletal survey (using X-rays and/or other clinically appropriate imaging 
[MRI, whole body CT, or PET/CT]) will be performed during Screening 
and as clinically indicated, per Investigator’s discretion, during the study. 
If X-rays are used, they should include a lateral radiograph of skull, 
anterioposterior and lateral views of the spine, and anterioposterior views of 
the pelvis, ribs, femora, and humeri.  If lytic bone lesions or plasmacytomas 
are observed at Screening, their location and measurement should be recorded 
in the CRF. They should be re-assessed during the study, as clinically 
appropriate (per Investigator’s discretion) using the same imaging modality 
that was used at Screening. 
Plasmacytoma 
If plasmacytomas ≥2cm in at least one dimension are detected at baseline by 
physical examination or imaging (MRI, ultrasound, whole body CT, or 
PET/CT), they should be serially measured and recorded for response 
determination.  Plasmacytomas that are measurable by physical exam must be 
assessed during the physical exam on Day 1 of each cycle.  Plasmacytomas that 
are seen by imaging during Screening should be re-assessed during the study as 
clinically appropriate (per Investigator discretion) using the same imaging 
modality that was used at Screening. 
Bone marrow aspirate/core biopsy 
The bone marrow aspirate obtained at Screening will be used for (a) My-DST 
assessment (b) fluorescence in situ hybridization (FISH) analysis to confirm 
diagnosis and classify MM sub-type, and A bone marrow aspirate and/or core 
biopsy is/are required when there is negative immunofixation of serum and 
urine, and disappearance of any soft tissue plasmacytomas. 
 
Response will be assessed per modified IMWG response criteria for MM as the following (see 
appendix 5): 
 Stringent complete response (sCR) 
 Complete response (CR) 
 Very good partial response (VGPR) 
 Partial response (PR) 
 Minimal response (MR) 
 Stable disease (SD) 
 Progressive disease (PD) 
 
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8.4 
Safety Assessments 
8.4.1 
Adverse Events 
Information regarding AEs and SAEs will be collected. See Section 9. 
8.4.2 
Concomitant Medications 
Concomitant medications will be documented for each patient at each scheduled visit after 
consent. A detailed history of medications will be documented. At each study visit, patients will 
be asked whether they have taken any medication other than the study treatment (from screening 
through the end of treatment). All concomitant medications including dietary supplements, over-
the-counter medications, and oral herbal preparations, as well as changes in medication, should 
be recorded.  
Necessary supportive care such as appetite stimulants, anti-emetics, and anti-diarrheals, etc., is 
allowed (see Section 7.10.1, Section 7.10.2, and Table 3). 
 
 Medications Administered During Hospitalizations 
Due to the large amount of data generated during hospitalizations, a targeted concomitant 
medication collection approach may be utilized for the CRF.  
 
8.4.3 
Clinical Safety Assessments 
 Weight, Height, and BSA 
Height (without shoes) in centimeters and weight (indoor clothing without shoes) in kilograms 
will be recorded. BSA will be calculated by the Dubois (Dubois 1916) or Mosteller (Mosteller 
1987) method to determine the volume of carfilzomib to be administered and to ensure that an 
individual patient's selinexor dose does not exceed 70 mg/m2 or 120 mg per dose for any adult 
patient or 55 mg/m2 for any pediatric patient. 
 Physical Examination, Vital Signs, and ECOG Performance 
Status  
Complete physical examinations should include general appearance, skin, neck, eyes, ears, nose, 
throat, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological examinations.  
Symptom-directed physical examinations should include body systems as appropriate. These 
examinations will be performed according to the standards at each institution. 
Information about the physical examinations must be present in the source documentation at the 
study site. Clinically relevant findings made after the start of study dosing, which meet the 
definition of an AE, must be recorded. 
Vital signs include systolic and diastolic blood pressure, pulse measurements, and body 
temperature. Vital signs should be assessed predose on the scheduled visit day, if possible. Blood 
pressure and pulse rate should be measured after the patient has been in a supine or sitting position 
for 5 minutes and assessed on the same arm throughout the study.  
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The ECOG performance status assessments (Oken 1982) will be performed during the study to 
assess how the disease affects the daily living abilities of the patients (<Appendix 4>). 
 
8.4.4 
Electrocardiography  
A standard 12-lead ECG will be performed. Patients must rest for at least 5 minutes prior to the 
ECG recording. The date and time the ECG was performed and the following parameters will be 
recorded: heart rate, PR interval, QT interval, QRS interval, and QT corrected using Fridericia's 
formula (Fridericia 1920). The Investigator will interpret the ECG using 1 of the following 
categories: normal, abnormal but not clinically significant, or abnormal and clinically significant. 
8.4.5 
Laboratory Safety Assessments 
 Clinical Laboratory Tests 
Table 8 presents the clinical laboratory tests that will be performed during the study. 
Table 8: 
Clinical Laboratory Tests 
Complete Blood Count with Differential  
Hemoglobin 
Hematocrit 
Lymphocytes 
 
 
WBC count 
RBC 
 
 
 
Neutrophils 
Platelets 
 
 
 
Complete Serum Chemistry  
Sodium* 
Potassium* 
Chloride* 
Bicarbonate* 
Urea or BUN*, b 
Creatinine* 
Glucose* 
Calcium 
Phosphate 
Magnesium 
ALT* 
AST* 
 
 
 
Pregnancy Test (if applicable) 
Beta 2 
Microglobulin 
 
 
Coagulation 
 
 
 
 
PT 
PTT 
INR 
 
 
Urinalysis 
 
 
 
 
Multiple Myeloma 
Assessment+ 
 
 
 
 
SPEP, Protein, total 
for SPEP/ 
Serum Protein 
Immunofixation 
24 hr UPEP/Urine 
Protein 
Immunofixation 
Quantative 
Immunoglobulins 
(IgA, IgG, IgM) 
Serum Free light 
chains 
 
ALT: alanine aminotransferase; AST: aspartate aminotransferase; BUN: blood urea nitrogen;; LDH: lactate 
dehydrogenase; RBC: red blood cell; WBC: white blood cell, CRP; C-reactive protein 
*=Limited serum chemistry; + = as applicable to MM disease, reference IE 
a. 
WBC differential may be automated or manual as per institutional standards. Reticulocytes may be done 
only when clinically indicated. 
b. Urea (mg/dL) = Blood urea nitrogen (mg/dL) × 2.14. 
c. 
Microscopy will only be performed if clinically indicated. 
All laboratory safety assessments will be performed and analyzed at each site by a certified local 
laboratory. The Investigator or designee will review the laboratory results and assess the clinical 
significance of all abnormal values. Appropriate action will be taken for any clinically significant 
abnormal values. Values will be documented on the laboratory report until stabilized, or the 
laboratory value returns to a clinically acceptable range (regardless of relationship to study 
treatment) or baseline. 
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Any laboratory value that remains abnormal at the End of Treatment (EoT) Visit and that is 
considered clinically meaningful will be followed according to accepted medical standards for 
up to 30 days or until resolution of the abnormality or return to baseline. Toxicity will be graded 
using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events 
(CTCAE) v 5 
A copy of the laboratory certification and normal ranges for each parameter measured must be 
provided to the Sponsor.  
 Pregnancy Testing 
For females of childbearing potential, a negative serum human chorionic gonadotropin (hCG) 
pregnancy test must be obtained within 3 days before the first dose of study treatment. Test 
sensitivity for hCG must be ≥ 25 mIU/mL. A serum hCG pregnancy test is also required for these 
patients at the EoT Visit. 
Pregnancy testing (serum hCG or urine) is also required for females of childbearing potential 
prior to dosing on Day 1 of cycles 1, 2 and subsequent even numbered cycles while on treatment. 
A negative pregnancy test must be documented prior to administration of study drug. 
Pregnancy testing may also be performed as clinically indicated during the study. 
8.5 
Other Assessments 
8.5.1 
Nutritional Consultation 
Patients will be given nutritional consultation, if clinically indicated and per investigator 
discretion, to discuss any food recommendations and strategies for managing potential nausea 
and appetite changes experienced with selinexor. This consultation may be given by a study 
investigator or nurse and can be done by phone. 
8.5.2 
Subject Contact 
A telephone call, email or in-person visit will be performed at the following time points: 
 Selinexor-containing regimens only: On C1D3, 2 days following the first dose of 
selinexor on C1D1. The purpose of this telephone call is to evaluate supportive care 
medications, concomitant medications, and AEs, and to adjust supportive care as 
appropriate. The contact with the patient should take place on C1D3, 2 days following 
the first dose of selinexor on C1D1. 
 At the Safety Follow-up. The purpose of this telephone call, email or in-person visit with 
the patient is to assess the overall medical condition of the patient and status of their MM, 
follow up on any AEs that were not resolved at the EoT Visit, and collect information 
regarding any antineoplastic therapies used after Endo fo Treatment. 
8.5.3 
Durability of Response and Survival Follow-up Visit(s) 
After discontinuation of selinexor based combination (End of Treatment), if feasible and 
clinically indicated, the following assessments should be performed at Durability of Response 
and Survival Follow-up Visits for patients who have not progressed to assess durability of 
response: 
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 SPEP and serum protein immunofixation 
 Urine protein electrophoresis (UPEP; 24-hour urine) and 
urine protein immunofixation (if applicable per MM Disease 
protocol, consult Investigator) 
 Serum FLC 
 Quantitative Ig levels 
 Bone marrow aspirate, as clinically indicated, to assess progression 
 Re-assessment of plasmacytomas by physical examination (if 
detected by physical examination at Screening) 
 Skeletal survey (imaging) for bone lesions, including tumor 
measurements as clinically indicated to document response, at 
frequency determined by the Investigator 
 
If these assessments cannot be performed, at a minimum, a telephone call, email or in-person 
visit will be made to the patient (or the patient’s family) to assess the survival status, status of the 
patient’s MM, and overall medical condition of the patient and collect information on any 
antineoplastic therapies used after discontinuation of study treatment. 
For subjects who have had progressive disease, none of the above assessments are required. 
 
9 
SAFETY DEFINITIONS, RECORDING, AND REPORTING 
9.1 
Adverse Events 
9.1.1 
Definitions 
 Adverse event (AE): Any untoward medical occurrence in a patient or clinical investigation 
subject administered a pharmaceutical product and which does not necessarily have to have 
a causal relationship with this treatment. An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding, for example), symptom, or 
disease temporally associated with the use of study treatment, whether or not considered 
related to the study treatment.  
 Life-threatening adverse event or life-threatening suspected adverse reaction: An adverse 
event or suspected adverse reaction is considered "life-threatening" if, in the view of either 
the investigator or sponsor, its occurrence places the patient or subject at immediate risk of 
death. It does not include an adverse event or suspected adverse reaction that, had it occurred 
in a more severe form, might have caused death. 
 Treatment-emergent adverse event (TEAE): Any event that was not present prior to the 
initiation of study treatment or any event already present that worsens in either intensity or 
frequency following exposure to study treatment.  
 Serious adverse event (SAE): Any untoward medical occurrence that, at any dose, results in 
death; is life threatening (ie, an event in which the patient was at risk of death at the time of 
the event; it does not refer to an event that hypothetically might have caused death if it were 
more severe); requires inpatient hospitalization or prolongation of existing hospitalization; 
results in persistent or significant disability/incapacity; or is a congenital anomaly/birth 
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defect. Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the patient or subject and may require medical or surgical intervention 
to prevent one of the outcomes listed in this definition. 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 inpatient hospitalization, or the 
development of drug dependency or drug abuse. (See Section 10.2.3 for additional 
information about SAE reporting.)  
 Suspected adverse reaction: Any adverse event for which there is a reasonable possibility 
that the drug caused the adverse event. For the purposes of IND safety reporting, "reasonable 
possibility" means there is evidence to suggest a causal relationship between the drug and the 
adverse event. Suspected adverse reaction implies a lesser degree of certainty about causality 
than adverse reaction, which means any adverse event caused by a drug. 
 Unexpected adverse event or unexpected suspected adverse reaction: An adverse event or 
suspected adverse reaction is considered "unexpected" if it is not listed in the investigator 
brochure or is not listed at the specificity or severity that has been observed; or, if an 
investigator brochure is not required or available, is not consistent with the risk information 
described in the general investigational plan or elsewhere in the current application, as 
amended. For example, under this definition, hepatic necrosis would be unexpected (by virtue 
of greater severity) if the investigator brochure referred only to elevated hepatic enzymes or 
hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected 
(by virtue of greater specificity) if the investigator brochure listed only cerebral vascular 
accidents. "Unexpected," as used in this definition, also refers to adverse events or suspected 
adverse reactions that are mentioned in the investigator brochure as occurring with a class of 
drugs or as anticipated from the pharmacological properties of the drug, but are not but are 
not specifically mentioned as occurring with the particular drug under investigation. 
9.1.2 
Recording of Adverse Events 
Adverse Events will be reported and recorded in the eCRF from the time of the first dose of study 
drug through 30 days after the last dose of protocol required therapies or until the start of subsequent 
antineoplastic therapy, whichever occurs first. That is, if a patient begins a new antineoplastic 
therapy, the AE reporting period for nonserious AEs ends at the time the new treatment is started. 
SAEs during screening will only be reported if related to study procedure.  
AE monitoring should be continued for at least 30 days following the last dose of protocol required 
therapies (ie, through 30 days following last dose or until resolution or through the end of the study 
for events considered related to study treatment by the Investigator).  
AEs (including laboratory abnormalities that constitute AEs) should be described using a 
diagnosis whenever possible, rather than individual underlying signs and symptoms. When a 
clear diagnosis cannot be identified, each sign or symptom should be recorded as a separate AE. 
The Investigator should ask the patient non-leading questions to determine if any AEs have 
occurred during the study, since the last visit. AEs may also be recorded when they are 
volunteered by the patient, or through physical examination, laboratory tests, or other clinical 
assessments. 
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An AE should be followed and an assessment should be made at each visit (or more frequently, 
if necessary) of any changes in severity of the event, the suspected relationship to the study 
treatment, the interventions required to treat the event, and the outcome. 
 Laboratory Test Abnormalities 
Laboratory abnormalities that constitute an AE in their own right (ie, are considered to be 
clinically significant, induce clinical signs or symptoms, require concomitant therapy, or require 
changes in study treatment), should be recorded as an AE. Whenever possible, a diagnosis, rather 
than a symptom should be provided (eg, anemia instead of low hemoglobin).  
Laboratory abnormalities that meet the criteria for an AE should be followed until they have 
returned to baseline levels (as measured during the Screening Visit) or an adequate explanation 
of the abnormality is identified. When an abnormal laboratory or test result corresponds to a 
sign/symptom of an already reported AE, it is not necessary to separately record the 
laboratory/test result as an additional event. 
A laboratory abnormality that does not meet the definition of an AE should not be recorded as 
an AE. A Grade 3 or 4 event (considered to be severe per the current version of NCI CTCAE) 
does not automatically indicate an SAE unless it meets the definition of serious as defined in 
Section 9.1.1 and/or as per the opinion of the Investigator. A laboratory abnormality that results 
in a dose being held or modified would, by definition, be an AE and must be recorded as such. 
9.1.3 
Adverse Event Severity 
The term “severe” is used to describe the intensity of an AE; the event itself could be of relatively 
minor clinical significance (eg, ‘severe’ headache). This is not the same as a “serious” AE. 
The severity of the AE will be graded by the Investigator according to the NCI CTCAE Grading 
Scale, v. 5.0 (the NCI CTCAE files can be accessed online at the following URL: 
http://evs.nci.nih.gov/ftp1/CTCAE/About.html). 
If there is not a specific NCI CTCAE grading scale for an AE, the severity will be characterized 
as mild, moderate, severe, or life-threatening according to the following definitions: 
 Grade 1 (mild) events are usually transient and do not interfere with the patient’s daily 
activities. 
 Grade 2 (moderate) events introduce a low level of inconvenience or concern to the 
patient and may interfere with daily activities. 
 Grade 3 (severe) events interrupt the patient’s usual daily activities. 
 Grade 4 events are those that are considered to be life-threatening.  
9.1.4 
Adverse Event Causality 
The Investigator will make a judgment regarding the relationship of the AE to each study 
treatment, as defined below. 
 
Not related: These events will lack a strong temporal relationship of the event to the 
study treatment, making a causal relationship not reasonably possible. 
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Exposure to other drugs, therapeutic interventions, or underlying 
conditions may provide a sufficient explanation for the event. 
 Related: 
There is a temporal relationship of the event to the study treatment, and 
the event is more likely explained by exposure to the study treatment 
than by any other drugs, therapeutic interventions, or underlying 
conditions. 
9.2 
Serious Adverse Events 
See Section 9.1.1 for the definition of an SAE. Please note that SAEs that occur at any time 
between the signing of the ICF up to the first dose of study treatment, must be reported (in 
addition to SAEs that occur after the first dose of study treatment). Events that Do Not Meet the 
Definition of a Serious Adverse Event 
Elective hospitalizations to administer, or to simplify study treatment or study procedures (ie, an 
overnight stay to facilitate 24-hour urine collection) are not considered SAEs. A ‘serious’ 
hospitalization is defined as any inpatient hospital admission that includes a minimum of an 
overnight stay in a health care facility. An emergency room visit is not considered a 
hospitalization unless it results in an official admission as in inpatient to the hospital (eg, 
undesirable effects of any administered treatment) and must be documented as an SAE. 
Progression of the malignancy/disease (including fatal outcomes) should NOT be reported as an 
SAE during the study or within the safety reporting period (see Section 9.2.2). Sudden or 
unexplained death should be reported as an SAE. If there is any uncertainty about a finding being 
due solely to progression of malignancy/disease, the finding should be reported as an AE or SAE, 
as appropriate. 
9.2.1 
Recording of Serious Adverse Events 
It is the responsibility of the Investigator to record and document all SAEs occurring from the 
time when the ICF is signed until at least 30 days after the patient has stopped study treatment,  
SAEs during screening will only be reported if related to study procedure. All SAEs must be 
reported on Karyopharm’s SAE Report Form in addition to being recorded in the sponsor’s 
database. The original SAE Report Form must be retained in the Investigator’s site file. 
All applicable sections of the SAE Report Form must be completed in order to provide a clinically 
thorough report. The Investigator must assess and record the relationship of each SAE to study 
treatment and complete the SAE Report Form in English. 
9.2.2 
Reporting of Serious Adverse Events 
Every SAE, regardless of the causal relationship to the Karyopharm study drug, occurring after 
the patient has signed informed consent until at least 30 days after the patient has stopped the 
Karyopharm study drug must be reported to the HCTU Quality Team and Karyopharm 
Pharmacovigilance Department within 24 hours of learning of its occurrence. The investigational 
site personnel must use the SAE Report Form provided by Karyopharm for reporting any SAE 
to the HCTU Quality Team and Karyopharm Pharmacovigilance Department (Appendix 
1).Appendix1 
The investigator will complete an SAE Form within the following timelines: 
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 All deaths and immediately life-threatening events, whether related or unrelated, will be 
recorded on the SAE Form and submitted to the Karyopharm within 24 hours of site 
awareness.  
 Other SAEs, regardless of relationship, will be submitted to the Karyopharm within 72 
hours of site awareness. 
Upon completion, the SAE Report Form must be immediately emailed or faxed to: 
Pharmacovigilance Department 
Karyopharm Therapeutics Inc. 
Email: pharmacovigilance@karyopharm.com and HCTU.quality@ucdenver.edu   
Fax: 
+1-617-334-7617 (USA) 
+49-89-9218-5650 (Germany) 
Any SAE observed after the 30-day follow-up period should only be reported to HCTU Quality 
Team and Karyopharm if the Investigator suspects that the SAE has causal relationship to the 
Karyopharm study drug. Recurrent episodes, complications, or progression of the initial SAE 
must be reported as follow-up to the original episode within 24 hours of the Investigator receiving 
the follow-up information. 
An SAE should be followed and an assessment should be made at each study visit (or more 
frequently, if necessary) of any changes in severity of the event, the suspected relationship to the 
study treatment, the interventions required to treat the event, and the outcome of the event. 
Investigators are responsible as applicable for notifying their appropriate Health Authorities, 
Institutional Review Board or Local and Central Ethics Committees (EC) of all SAEs in 
accordance with local regulations.  
The study sponsor (sponsor-investigator) will be responsible for notifying FDA of any 
unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case 
later than 7 calendar days after the sponsor’s initial receipt of the information. 
Karyopharm may report applicable SAEs to other applicable regulatory authorities and 
Investigators utilizing selinexor, as may be required. 
9.2.3 
Suspected Unexpected Serious Adverse Reactions 
Suspected unexpected serious adverse reactions (SUSARs) are SAEs that are unexpected (per 
the Reference Safety Informantion section of the current version of the IB for selinexor or the 
product label for daratumumab, carfilzomib and pomalidomide) and judged by the Sponsor-
Investigator or Karyopharm to be related to the Karyopharm study drug administered. All 
SUSARs will be collected and reported to the competent authorities and relevant ethics 
committees in accordance with the FDA’s “Safety Reporting Requirements for Investigational 
New Drugs and Bioanalytical/Bioequivalence Studies” (FDA 2012) or as per national regulatory 
requirements in participating countries. 
Selinexor SUSARs originating from Karyopharm’s CSTs in specific countries do not need to 
be cross-reported to the Competent Authorities. Please see memo in Appendix 3, for more 
information (list of countries). 
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In addition, Karyopharm will communicate all cases of cerebellar toxicity, Grade 3 or higher, to 
regulatory authorities, central ethics committees (eg, IRBs), and Investigators, in the format of 
an expedited Safety Report, within 7 days of awareness of the event. 
9.2.4 
Adverse Event Reporting 
The Investigator will report all AEs (including all non-serious AEs) to Karyopharm 
Pharmacovigilance twice per year in the form of line-listings in an excel spreadsheet.  
Karyopharm, the drug supplier, will supply the cut-off dates of each requested line listing.  
The line listings will contain the following information: study ID, unique subject ID, adverse 
event term, serious event (yes or no), onset date (complete or partial), end date (complete or 
partial), action taken with selinexor, causality to selinexor, event ongoing (yes or no), 
outcome of AE, severity CTCAE Grade (1-5), subject dosed with selinexor (yes or no), date 
of first dose of selinexor, MedDRA preferred term, system organ class (optional) 
See the excel spreadsheet template in Appendix 2. 
9.3 
Procedures for Handling Special Situations 
9.3.1 
Pregnancy and Breastfeeding 
Note: Pregnancy per se is not considered to be an AE; however, it is discussed here because of 
the importance of reporting pregnancies that occur during studies and because a medical 
occurrence observed in the mother or fetus/newborn would be classified as an AE. 
Female patients of childbearing potential and fertile male patients will be informed as to the 
potential risk of conception while participating in this study and will be advised that they must 
use highly effective contraception listed below (ie, results in a low failure rate when used 
consistently and correctly) during the dosing period and for a period of at least 3 months after the 
end of treatment. 
A list of highly effective methods of contraception is provided in Section 7.10.3. 
A pregnancy test will be performed on each premenopausal female patient of childbearing 
potential prior to the first dose of study drug, on Day 1 of Cycles ≥2 while on treatment, and 
again at treatment discontinuation during the End-of-Treatment visit. A negative pregnancy test 
must be documented prior to administration of study drug. 
If a patient is confirmed pregnant during the study, study drug administration must be 
discontinued immediately. The Investigator must immediately notify the Sponsor investigator of 
this event and record the Pregnancy on the Pregnancy Form. The initial information regarding a 
pregnancy must be forwarded to Karyopharm’s Pharmacovigilance Department by email or fax 
within 24 hours of first knowledge of its occurrence. A pregnancy report form is provided by 
Karyopharm Pharmacovigilance. 
The pregnancy should be followed up to determine the outcome, including spontaneous or 
voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications.  
All pregnancies occurring within 3 months after the patient’s last dose of protocol required 
therapies must be reported to Karyopharm, regardless of whether the patient received the 
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Karyopharm study drug or other study drugs, withdraws from the study, or the study is 
completed. Patients should be instructed to inform the Investigator regarding any pregnancies.  
Any SAE that occurs during pregnancy must be recorded on the SAE report form (eg, maternal 
serious complications, therapeutic abortion, ectopic pregnancy, stillbirth, neonatal death, 
congenital anomaly, or birth defect) and reported within 24 hours in accordance with the 
procedure for reporting SAEs (described in Section 9.2.2). 
A pregnancy in a female partner of a male patient must be reported to Karyopharm 
Pharmacovigilance within 24 hours of learning of its occurrence. Pregnancies in female partners 
should only be followed if the male patient is being treated with a selinexor-containing regimen. 
Consent to report information regarding these pregnancy outcomes should be obtained from the 
female partner. 
It is not known whether selinexor passes into the breast milk. Mothers should not breastfeed 
while being treated with a selinexor-containing regimen.  
 
10 DISCONTINUATION CRITERIA 
10.1 Early Study Termination, Study Treatment Discontinuation, and 
Patient Withdrawal Criteria 
10.2 Early Termination of the Study 
The study may be terminated at the discretion of the Sponsor or drug supplier for any reason, 
including medical or ethical reasons affecting the continued performance of the study, or 
difficulties in the recruitment of patients.  
The Sponsor, in conjunction with appropriate regulatory authorities and the drug supplier, would 
then decide if the study should be modified or terminated. 
An efficacy-based stopping rule will be in place for this study.  Efficacy will be assessed using 
the proportion of patients who achieve at least a partial response, as defined by IMWG criteria. 
The complementary failure rate—the rate of patients who do not achieve at least a partial 
response—will be assessed throughout the study. If at any time in the study the upper bound of 
the 90% confidence interval for the failure rate exceeds 50%, then the study will be stopped for 
efficacy. 
A safety-stopping rule will also be implemented.   In order to monitor toxicity events in this trial, 
we will assess the number of SAEs or non-hematologic grade 4 or higher toxicity events after 6 
patients have been given the treatment regimen.  Assuming 25% as an acceptable rate of toxicity 
events and assuming 40% as an unacceptable rate of toxicity events for this trial, we determine 
the following stopping rule (equivalent to determining Pocock boundaries with the same 
significance level used at both looks and an overall alpha level of 0.05): stop the trial if more 
than 3 toxicity events are observed in the first 6 patients.  Assuming no more than 3 toxicity 
events are observed in the first 6 patients, we treat an additional 6 patients (for a total n = 12) and 
declare acceptable toxicity levels in the trial if no more than 4 total toxicity events are observed 
in the first 12 patients.  
 
Table 1 summarizes the probability of observing a specified number of toxicity events in the first 
12-patient cohort being studied as well as the 90% confidence interval of the true proportion of 
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toxicity events.  These probabilities do not assume any underlying toxicity rate of the treatment 
regimen. 
 
 
 Table 1. 
Observed Number of drug-
related SAEs or grade 4 
non-heme toxicities (N=12) 
Percent of Toxicity Events 
90% CI for the Percent of 
Toxicity Events 
0 
0.0% 
(0.0%-22.1%) 
1 
8.3% 
(0.4%-33.9%) 
2 
16.7% 
(3%-43.8%) 
3 
25.0% 
(7.2%-52.7%) 
4 
33.3% 
(12.3%-60.9%) 
5 
41.7% 
(18.1%-68.5%) 
6 
50.0% 
(24.5%-75.5%) 
7 
58.3% 
(31.5%-81.9%) 
 
If any patient experiences death due to an adverse event that is assessed as related to study 
treatment (by investigator and/or Sponsor), it will lead to temporary hold of study pending 
review by study team. 
 
10.3 Discontinuation of Study Treatment and/or Withdrawal of Patients 
from the Study 
The Investigator may remove a patient from study treatment for any of the following reasons: 
 Unacceptable AEs or toxicity that cannot be managed by supportive care (this 
must be linked in the study database to the AE or toxicity event to support 
discontinuation). 
 Any medically appropriate reason or significant protocol violation, in the opinion 
of the Investigator 
The Investigator must remove a patient from study treatment for any of the following reasons: 
 Disease progression  
 Patient elects to discontinue study treatment 
 Pregnancy 
Patients may discontinue study treatment for any reason. Patients who choose to discontinue 
study treatment should be encouraged to continue in the study so that follow-up information on 
PD and survival status may be obtained. 
Patients may elect to withdraw consent and decline further participation in the study at any time. 
Patients who withdraw consent must be withdrawn from the study. 
The reason for the patient’s discontinuation of study treatment must be clearly documented in 
the study database and include supporting data (ie, discontinuation for PD must be accompanied 
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by data points in the database to support PD; additionally, if the reason for discontinuation is 
physician decision, ample justification must be provided and linked to PD values, AEs, etc.). 
Any patient who does not withdraw from the study but who stops attending study visits and does 
not respond to 3 documented contact attempts will be considered lost to follow-up. 
All patients will be followed until disease progression, they withdraw consent, are withdrawn 
from the study by the Investigator, have died, or have been lost to follow up. 
 
11 STUDY VISITS 
11.1 
Description of Study Days 
11.1.1 
Screening  
Screening will include the study procedures described below and will be performed within 28 
days prior to the start of therapy (ie, Day -28 to Day 1), as summarized in Schedule of 
Assessments and Study Schematics 
Table 1. The Investigator should not repeat procedures that are performed as part of standard of 
care (SOC), if they are within the screening window and are done prior to signing the ICF. Data 
from SOC procedures will be part of the patient's medical history and may be used for study 
purposes.  
Screening may be divided into two (or more) clinic visits at the discretion of the Investigator. 
The procedures to be performed during screening are listed below assuming such a division, 
however the decision is up to the Investigator, as long as all procedures are performed and 
Treatment assignment occurs prior to the first day of study administration.  
DAY -28 TO DAY -1  
 Sign written informed consent (note age on day consent signed) 
 Demographics (date of birth, age, gender, race, and ethnicity) 
 Height 
 Weight 
 Vital signs (BP, pulse, and temperature) 
 ECOG 
 Complete physical exam 
 12 lead ECG 
 ECHO or MUGA 
 Laboratory Assessment (CBC w/diff, chemistries, coagulation tests, urinalysis, LDH, CRP, 
TSH, PT/INR, PTT, pregnancy test) 
 Multiple 
Myeloma 
Assessment 
(SPEP/SIFE, 
24-hour 
UPEP/UIFE, 
quantitative 
immunoglobulins (IgG, IgA, IgM), serum free light chains, skeletal survey, bone marrow 
aspirate and core biopsy).  Bone marrow aspirate and core biopsy and imaging (skeletal 
survey, CT, MRI, PET) may be done from day -45 to Day -1.  
 QOL questionnaire 
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 Physician indicates choice of therapy without My-DST guidance. 
 My-DST assessment and cohort assignment as per discretion of treating physician 
 
11.1.2 
Cycle 1  
 
Study Procedures (Days 1-28) 
The procedures will be followed for all cohorts: 
 Weight (Days 1, 8, and 15) 
 Medical history review at baseline prior to first selinexor dosing (Day 1) 
 Vital signs (BP, pulse, and temperature Days 1, 8, and 15) 
 Symptom directed (limited) PE 
 Laboratory assessments (CBC with Differential and complete serum chemistry Days 1, 8 
and 15) 
 Multiple myeloma assessments, as applicable to MM disease, reference IE (SPEP/SIFE, 24-
hour UPEP/UIFE, quantitative immunoglobulins, serum free light chains Day 1) 
 
Study Treatment Dosing 
Arm 1 SPd 
• 
Selinexor 60 mg oral Days 1, 8, 15 
• 
Pomalidomide 4 mg oral on Days 1-21   
• 
Dexamethasone 40 mg IV or oral on Days 1, 8, 15, 22 
• 
28 Day treatment cycle 
 
Arm 2 SDd  
• 
Selinexor 80 mg oral Days 1, 8, 15 
• 
Daratumumab 1,800mg/30,000 units subcutaneous injection Days 1, 8, 15, 22 (may be 
substituted with IV Dara, if directed by Investigator) 
• 
Dexamethasone 40mg IV or oral Days 1, 8, 15, 22 
• 
28 Day treatment cycle 
 
Arm 3 SKd 
• 
Selinexor 80 mg oral Days 1, 8, 15 
• 
Carfilzomib 20 mg/m2 IV infusion Day 1, 56mg/m2 Days 8, 15 
• 
Dexamethasone 40 mg IV or oral Days 1, 8, 15, 22 
• 
28 Day treatment cycle 
 
Cycle 1 Day 3 (+1 day) Contact  
Telephone, email or in-person visit contact 
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11.1.3 
Cycles ≥2  
The procedures will be followed for all cohorts: 
 
Study Procedures 
 Weight (Day 1 of each cycle) 
 Vital signs (BP, pulse, and temperature) 
 Symptom-directed (limited) PE 
 Laboratory assessments (CBC with Differential and complete serum chemistry Day 1 of 
each cycle  
 Multiple myeloma assessments, as applicable to MM disease, reference IE (SPEP/SIFE, 24-
hour UPEP/UIFE, quantitative immunoglobulins, serum free light chains Day 1 of each 
cycle) 
 QOL Questionnaire 
 
Study Treatment Dosing 
The treatments to be provided are summarized below, by cohort. Procedures will be performed 
pre-dose when they occur on clinic visit days.  
Arm 1 SPd 
• 
Selinexor 60 mg oral Days 1, 8, 15 
• 
Pomalidomide 4 mg oral on Days 1-21   
• 
Dexamethasone 40 mg IV or oral on Days 1, 8, 15, 22 
• 
28 Day treatment cycle 
 
Arm 2 SDd  
• 
Selinexor 80 mg oral Days 1, 8, 15 
• 
Daratumumab 1,800mg/30,000 units subcutaneous injection Days 1, 8, 15, 22 of cycle 2; 
Days 1, 15 of cycles 3-6; Day 1 of cycles 7+ (may be substituted with IV Dara, if directed by 
Investigator) 
• 
Dexamethasone 40 mg IV or oral Days 1, 8, 15, 22 
• 
28 Day treatment cycle 
 
Arm 3 SKd 
• 
Selinexor 80 mg oral Days 1, 8, 15 
• 
Carfilzomib 56 mg/m2 IV infusion Days 1, 8, 15 
• 
Dexamethasone 40 mg IV or oral Days 1, 8, 15, 22 
• 
28 Day treatment cycle 
 
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11.1.4 
End-of-Treatment Visit (≥30 Days after Last Dose) 
Study procedures will be performed at 30 days (+ 7 days) after the last dose of protocol required 
therapies for all patients, including early termination patients, as summarized below. 
 Weight 
 Vital signs (BP, pulse, and temperature) 
 ECOG 
 Complete physical exam 
 12 lead ECG 
 TTE or MUGA 
 Laboratory Assessment (CBC w/diff, complete serum chemistry, coagulation tests (PT/INR 
and PTT), urinalysis, CRP, LDH, TSH) 
 Multiple Myeloma Assessment, as applicable to MM disease, reference IE (SPEP/SIFE, 24-
hour UPEP/UIFE, quantitative immunoglobulins, serum free light chains, skeletal survey) 
 QOL Questionnaire 
11.1.5 
 Survival Follow-Up 
After end of treatment visit, a telephone call, email or visit will be made to the patient (or the 
patient’s family) annually, for 2 years, to inquire about the patient’s MM status, general health, 
and information on any antineoplastic therapies utilized since last contact. 
 
12 PLANNED STATISTICAL METHODS 
12.1 General Considerations 
PhD biostatistician and member of the Center for Innovative Design and Analysis at the 
University of Colorado-Anschutz has responsibility for statistical analysis for this study. 
Analyses will be conducted using SAS version 9.4. All individuals enrolled in the study will be 
included in analysis. In the event that an individual is lost to follow-up and does not have data 
for the endpoint of interest, that individual cannot be included to determine response rate. 
However, sensitivity analysis will be conducted for individuals lost to follow-up to determine 
how this might affect results. Sample size calculations assume a power of 80% and Type I error 
rate of 10%. Analysis Type I error rates for time to event endpoints will be set at 5%. 
 
Efficacy endpoints include proportions (overall response rate, MRD negative response rate, 
occurrence rate for adverse events, rate of assay failure) and time to event outcomes (progression 
free survival, duration of response, overall survival, and time to next treatment). For endpoints 
that are proportions, the study proportion will be calculated using the Intent to Treat Population. 
Accompanying one-sided 90% confidence intervals surrounding the proportion will be reported. 
For time to event endpoints, survival curves and median survival times with corresponding two-
sided 95% confidence intervals will be computed using Kaplan Meier methods. 
 
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12.2 Determination of Sample Size 
The primary endpoint of this study will be the overall response rate achieved with physician’s 
choice selinexor based combination therapy. With this treatment approach, we anticipate the 
response rate will increase to 75%. The null hypothesis is that the true response rate is 51%. 
Using a one-sided type I error rate of 10%, then given a sample size of 18, there is 80% power 
to detect a difference with an effect size of 24% when performing a difference in proportion test 
with normal approximation.  
12.3 Analysis Populations 
Analysis of the primary endpoint of response rate (partial response rate or better) will be 
performed on the Intent-to-treat (ITT) population, which will include all subjects who have been 
enrolled for the study.  For individuals lost to follow-up, sensitivity analyses will be performed 
to see how missing data for response rate affects analysis results. Sample sizes for each treatment 
arm individually will be too small to formally test hypotheses for each treatment arm, and 
response rates for these arms will be descriptive in nature. 
 
Secondary endpoints will be descriptive in nature, and no formal statistical analyses will be 
conducted on them. 
12.3.1 
Safety Population 
There is no safety population—only summary response rates for a standard of care population. 
12.4 Demographics and Baseline Characteristics 
Demographic and baseline characteristic data will be collected including myeloma specific data, 
prior treatment exposures, lab and bone marrow biopsy/aspirate results. No formal tests of 
hypotheses will be made for baseline and demographic data. Qualitative variables will be 
summarized by frequency tables. Quantitative measures will be summarized by mean and 
standard deviation values. 
12.5 Efficacy Analysis 
Efficacy will be assessed using the proportion of patients who achieve at least a partial response, 
as defined by IMWG criteria. The complementary failure rate—the rate of patients who do not 
achieve at least a partial response—will be assessed throughout the study. If at any time in the 
study the upper bound of the one-sided 90% confidence interval for the failure rate exceeds 51%, 
then the study will be stopped for efficacy. 
 
The table below shows the number of failures to respond to treatment, the corresponding response 
failure rate in the study population, and the one-sided 90% confidence interval for the failure 
rate. If the proposed study finds more than 5 patients fail to respond, then a 51% failure rate could 
no longer be ruled out with 90% confidence. 
 
Number of Patients Who 
Fail to Respond 
Failure Rate 
One-sided 90% 
Confidence Interval for 
Failure Rate 
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0 
0% 
0% - 12.0% 
1 
5.6% 
0% - 20.0% 
2 
11.1% 
0% - 26.9% 
3 
16.7% 
0% - 33.4% 
4 
22.2% 
0% - 39.6% 
5 
27.8% 
0% - 45.5% 
6 
33.3% 
0% - 51.2% 
 
 
12.6 Safety Analysis 
Adverse events including regimen toxicities will be summarized using tables and descriptive 
statistics as described below. 
12.6.1 
Adverse Events 
Adverse Events (AEs) will be coded using the MedDRA dictionary and displayed in tables and 
listings using System/Organ/Class (SOC) and Preferred Term.  
Analyses of AEs will be performed for those events that are considered to be treatment emergent 
AEs (TEAEs), defined as any AE with onset or worsening of a pre-existing condition on or after 
the first administration of protocol required therapies through 30 days following last dose or any 
event considered drug-related by the investigator through the end of the study. AEs with partial 
dates will be assessed using the available date information to determine if treatment-emergent; 
AEs with completely missing dates will be assumed to be treatment-emergent.  
AEs will be summarized by patient incidence rates. In all tabulations, a patient may contribute 
only once to the count for a given AE preferred term.  
The number and percentage of patients with TEAEs will be summarized, as well as the number 
and percentage of patients with TEAEs assessed by the Investigator as at least possibly related 
to treatment. The number and percentage of patients with any Grade ≥ 3 TEAE will be tabulated 
in the same manner. In the event a patient experiences repeated episodes of the same TEAE, the 
event with the highest severity and/or strongest causal relationship to study treatment will be 
used for purposes of tabulations.  
Serious AEs (SAEs) will also be tabulated.  
No formal hypothesis-testing analysis of AE incidence rates will be performed.  
All AEs (treatment emergent and post-treatment) will be listed in patient data listings.  
Separate by-patient listings will be provided for the following: patient deaths, SAEs, and AEs 
leading to withdrawal.  
12.6.2 
Laboratory Data  
The actual value and change from baseline for each on study evaluation will be summarized for 
each clinical laboratory parameter, including hematology and clinical chemistry, by arm, and for 
all study patients combined. In the event of repeat values, the last non-missing value per study 
day/time will be used.  
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Severity of select clinical lab measures will be determined using CTCAE criteria (ie, those 
measures that have a corresponding CTCAE grade classification). Labs with CTCAE Grades ≥ 
3 will be presented in a data listing. Shift tables that present changes from baseline to worst on-
study values relative to CTCAE classification ranges will be produced.  
12.6.3 
Vital Signs and Physical Examinations  
The actual value and change from baseline to each on-study evaluation will be summarized for 
vital signs for all study patients combined. By-patient listings of vital sign measurements will be 
presented in data listings.  
Physical examination results at screening will be summarized; all other abnormal physical 
examination data will be recorded. All examination findings will be presented in a data listing.  
 
13 ADMINISTRATIVE MATTERS 
13.1 
Regulatory and Ethical Compliance  
This clinical study was designed and will be implemented and reported in accordance with the 
ICH Harmonised Tripartite Guidelines for Good Clinical Practice (GCP). Applicable local 
regulations, including European Directive 2001/20/EC and United States Code of Federal 
Regulations Title 21, and the ethical principles outlined in the Declaration of Helsinki will be 
followed. 
13.2 Ethics Committees 
The protocol, the proposed ICF, and any other relevant records must be reviewed and approved 
by a properly constituted ethics committee (eg, IRB) before study start.  
13.3 Regulatory Authority Approval 
Before implementing this study, the protocol must be approved by relevant, competent regulatory 
authorities. 
13.4 Protocol Adherence  
Prior to study start, the Investigator is required to sign a protocol signature page confirming 
his/her agreement to conduct the study in accordance with the instructions and procedures found 
in this protocol and to give access to all relevant data and records to the drug supplier, Quality 
Assurance representatives, designated agents of the Sponsor-Investigator, ethics committees, and 
regulatory authorities as required. Investigators attest they will apply due diligence to avoid 
protocol deviations. All significant protocol deviations will be recorded and reported in the 
clinical study report (CSR). A significant protocol deviation is defined as any change to the 
execution of the protocol, that affects the scientific integrity or design of the study, or the rights, 
safety or welfare of study patients. 
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13.5 Amendments to the Protocol  
Any significant change or addition to the protocol by the Sponsor-Investigator can only be made 
in a written protocol amendment that must be provided by the Sponsor-Investigator, 
reviewed/approved by the drug supplier, and approved by Health Authorities where required, and 
the ethics committee (eg, IRB). Only amendments that are required for clarification or patient 
safety, by the Sponsor-Investigator, may be implemented prior to ethics committee (eg, IRB) 
approval. Notwithstanding the need for approval of formal protocol amendments, the Investigator 
is expected to take any immediate action required for the safety of any patient included in this 
study, even if this action represents a deviation from the protocol. In such cases, the Sponsor-
Investigator should be notified of this action and the ethics committee (eg, IRB) at the study site 
should be informed according to local regulations but not later than 10 working days. 
13.6 Informed Consent 
Eligible patients may only be included in the study after providing written (witnessed, where 
required by law, ethics committee [eg, IRB], or regulation), ethics committee (eg, IRB)-approved 
informed consent. 
Informed consent must be obtained before conducting any study-specific procedures. Procedures 
that are part of the clinical routine evaluations during the initial diagnostic work-up of the patient 
may be performed before the ICF is signed and dated (ie, procedures that are not specific to the 
conduct of the study). 
Informed consent must also be obtained for patients before conducting any study-specific 
procedures for treatment. 
The process of obtaining informed consent should be documented in the patient source 
documents. A copy of the ICF must be given to the patient or to the person signing the form on 
behalf of the patient. The Investigator or designee must record the date when the study ICF was 
signed in the medical records of the patient. The name and role of the witness, if required, should 
also be documented. 
The Sponsor-Investigator will provide to the drug supplier, in a separate document, a proposed 
ICF that is appropriate for this study and complies with the ICH GCP guideline and regulatory 
requirements.  
13.7 Patient Confidentiality and Disclosure 
The Investigator must ensure anonymity of all patients; patients must not be identified by names 
in any documents submitted to the drug supplier or its designee. Signed ICFs and patient 
enrollment logs must be kept strictly confidential. 
13.8 Collection, Auditing Study Documentation, and Data Storage 
13.8.1 
Study Documentations, Record Keeping and Retention of Documents 
Each participating site will maintain appropriate medical and research records for this study, in 
compliance with Section 4.9 of ICH E6 GCP, and according to the regulatory and institutional 
requirements.  
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Source data include all information, original records of clinical findings, observations, or other 
activities in a clinical study necessary for the reconstruction and evaluation of the study.  
Data collection is the responsibility of the clinical study staff at the site under the supervision of 
the site Investigator. The study database is the primary data collection instrument for the study. 
The Investigator is responsible for the accuracy, completeness, and timeliness of the data reported 
in the database and all other required reports. Data reported in the database, which are derived 
from source documents, should be consistent with the source documents or the discrepancies 
should be explained. All data requested on the source documents must be recorded. Any missing 
data must be explained. If electronic records are used, an audit trail will be maintained by the 
system, in compliance with 21 CFR Part 11. 
The Investigator/institution should maintain study documents as specified in Essential 
Documents for the Conduct of a Clinical Trial (ICH E6 Section 8) and as required by applicable 
regulations and/or guidelines. The Investigator/institution should take measures to prevent 
accidental or premature destruction of these documents. 
Essential documents (written and electronic) should be retained for a period of not less than 
15 years from the completion of the clinical study unless the Sponsor provides written permission 
to dispose of them or, requires their retention for an additional period of time because of 
applicable laws, regulations, and/or guidelines. 
13.8.2 
Monitoring and Oversight 
The sponsor investigator will be responsible for monitoring the trial per the trial monitoring plan, 
in addition to overseeing the safety and efficacy of the trial including any specimens collected, 
executing the data and safety monitoring (DSM) plan, and complying with all reporting 
requirements to local and federal authorities. This oversight will be accomplished through 
additional oversight from the Data and Safety Monitoring Committee (DSMC) at the University 
of Colorado Cancer Center (CU Cancer Center). The DSMC is responsible for ensuring data 
quality and study participant safety for all clinical studies at the CU Cancer Center, which is the 
coordinating institution of this trial.  
 
A summary of the DSMC’s activities is as follows:  
 Conduct of internal audits  
 Ongoing review of all serious adverse events (SAEs) and unanticipated problems (UAPs)  
 Has the authority to suspend trials for safety or trial conduct issues  
 May submit recommendations for corrective actions to the CU Cancer Center’s Executive 
Committee  
 
Per the CU Cancer Center Institutional DSM Plan, SAEs and UAPs are reported to the DSMC, 
IRB and the sponsor investigator per protocol. All SAEs and UAPs are to be reported to the 
DSMC within 7 (for fatal or life-threatening events) or 15 (non-life-threatening events) calendar 
days of the sponsor investigator receiving notification of the occurrence. 
 
Each subject’s treatment outcomes will be discussed by the site PI and appropriate staff at 
regularly scheduled meetings. Data regarding number of subjects, significant toxicities, dose 
modifications, and treatment responses will be discussed and documented in the meeting’s 
minutes.  
 
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The sponsor investigator will provide a DSM progress report to the CU Cancer Center DSMC 
on a recurring basis (either every six or twelve months based on DSMC vote). The DSM report 
will include a protocol summary, current enrollment numbers, summary of toxicity data to 
include specific SAEs, UAPs and AEs, any dose modifications, all protocol deviations, and 
protocol amendments. The DSM progress report submitted to the DSMC will also include, if 
applicable, the results of any efficacy data analysis conducted. Results and recommendations 
from the review of this progress report by the DSMC will then be provided to the sponsor 
investigator in a DSMC review letter. The sponsor investigator is then responsible for ensuring 
this letter is submitted to the site’s IRB of record at the time of IRB continuing review. 
13.8.3 
Clinical Monitoring, Audit Procedures 
Clinical site monitoring will be conducted to ensure that the rights and well-being of human 
participants are protected, that the reported trial data are accurate, , legible, attributable, complete, 
and verifiable, and that the conduct of the trial is in compliance with the currently approved 
protocol/ amendment(s), with GCP, and with applicable regulatory requirement(s).  
Source documents (paper or electronic) are those in which patient data are recorded and 
documented for the first time.  They include, but are not limited to, hospital records, clinical and 
office charts, laboratory notes, memoranda, evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, copies of transcriptions that are certified after 
verification as being accurate and complete, microfiche, photographic negatives, microfilm or 
magnetic media, X-rays, patient files, and records kept at pharmacies, laboratories, and medico 
technical departments involved in a clinical trial. 
Monitoring for this study will be performed by a qualified research monitor in accordance with 
the clinical monitoring plan (CMP).  The CMP describes in detail who will conduct the 
monitoring, at what frequency monitoring will be done, at what level of detail monitoring will 
be performed, and the distribution of the monitoring reports. 
Source documents that are required to verify the validity and completeness of data entered into 
the eCRFs must not be obliterated or destroyed and must be retained per the policy for retention 
of records described in Section 13.8.1. 
To facilitate source data verification, the investigators and institutions must provide the study 
monitor(s) direct access to applicable source documents and reports for trial-related monitoring, 
Sponsor audits, and IRB/EC review.  The study site must also allow inspection by applicable 
health authorities. 
13.9 Termination of the Study 
It is agreed that, for reasonable cause, either the Sponsor-Investigator or drug provider, may 
terminate the Investigator’s participation in this study after submission of a written notice. The 
drug provider may terminate the study at any time upon immediate notice for any reason 
including the drug provider’s belief that discontinuation of the study is necessary for patient 
safety. 
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Sonneveld, P., Avet-Loiseau, H., Lonial, S., Usmani, S., Siegel, D., Anderson, K. C., . . . 
Orlowski, R. (2016). Treatment of multiple myeloma with high-risk cytogenetics: a consensus 
of the International Myeloma Working Group. Blood, 127(24), 2955-2962. doi:10.1182/blood-
2016-01-631200 
van Bueren, J. L., Jakobs, D., Kaldenhoven, N., Roza, M., Hiddingh, S., Meesters, J., . . . Parren, 
P. W. H. I. (2014). Direct in Vitro Comparison of Daratumumab with Surrogate Analogs of CD38 
Antibodies MOR03087, SAR650984 and Ab79. Blood, 124(21).  
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Sherbenou                                                                                                                                   Selinexor (KPT-330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 99 of 105 
Confidential 
Vij, R., Wang, M., Kaufman, J. L., Lonial, S., Jakubowiak, A. J., Stewart, A. K., . . . Siegel, D. 
S. (2012). An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in 
bortezomib-naive patients with relapsed and/or refractory multiple myeloma. Blood, 119(24), 
5661-5670. doi:10.1182/blood-2012-03-414359 
Walker, Z. J., VanWyngarden, M. J., Stevens, B. M., Abbott, D., Hammes, A., Langouet-Astrie, 
C., . . . Sherbenou, D. W. (2020). Measurement of ex vivo resistance to proteasome inhibitors, 
IMiDs, and daratumumab during multiple myeloma progression. Blood Adv, 4(8), 1628-1639. 
doi:10.1182/bloodadvances.2019000122 
 
 
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Sherbenou                                                                                                                                   Selinexor (KPT-
330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 100 of 105 
Confidential 
 
 
Serious Adverse Event Report Form 
<Karyopharm will provide the most recently approved version of this form to the 
Sponsor-Investigator, as needed.> 
 
 
 
 
 
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Sherbenou                                                                                                                                   Selinexor (KPT-
330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 101 of 105 
Confidential 
 
 Template for Line Listing of Adverse Events  
<Karyopharm will provide the most recently approved version of this form to the 
Sponsor-Investigator, as needed.> 
 
 
 
 
 
 
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Sherbenou                                                                                                                                   Selinexor (KPT-
330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 102 of 105 
Confidential 
 
Memo Regarding Cross-reported SUSARs from 
KPT CSTs 
Date:   25 October 2017 
Karyopharm Therapeutics, Inc. 
85 Wells Ave., 2nd floor Newton, MA 02459 
Phone: 617-658-0600 
Fax: 617-244-9420 
To:      Investigator Sponsored Trials that Utilize Selinexor 
RE:      Reporting of Selinexor SUSARs Originating from Company Sponsored Trials 
From:  Karyopharm Pharmacovigilance 
Dear Sponsor - Investigator: 
This memo is to clarify that Karyopharm reports all selinexor SUSARs originating from 
Company Sponsored Trials to all Competent Authorities involved in the review and approval 
of these Company Sponsored Trials. Your IST may be reviewed and approved by the same 
Competent Authority as a Karyopharm Company Sponsored Trial.  
Selinexor SUSARs originating from Company Sponsored Trials therefore do not need to be 
cross reported to the Competent Authorities of the Countries listed below. Please continue to 
cross report to your IRB/IEC and other applicable authorities as required by Good Clinical 
Practice and all national and local regulatory requirements. 
United States 
Canada  
Austria  
Belgium  
Bulgaria 
Czech Republic  
Denmark  
France  
Germany  
Greece  
Hungary 
Israel  
Italy 
Netherlands  
Poland  
Russia  
Serbia  
Spain 
United Kingdom 
Ukraine 
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Sherbenou                                                                                                                                   Selinexor (KPT-
330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 103 of 105 
Confidential 
 
Eastern Cooperative Oncology Group Performance 
Status Criteria 
ECOG Performance Status Scale 
Grade 
Descriptions 
0 
Normal activity. Fully active, able to carry on all pre-disease 
performance without restriction. 
1 
Symptoms, but ambulatory. Restricted in physically strenuous 
activity, but ambulatory and able to carry out work of a light or 
sedentary nature (eg, light housework, office work). 
2 
In bed < 50% of the time. Ambulatory and capable of all self-care, but 
unable to carry out any work activities. Up and about more than 50% 
of waking hours. 
3 
In bed > 50% of the time. Capable of only limited self-care, confined 
to bed or chair more than 50% of waking hours. 
4 
100% bedridden. Completely disabled. Cannot carry on any self-care. 
Totally confined to bed or chair. 
5 
Dead. 
Source: Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern 
Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649-655) 
 
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Sherbenou                                                                                                                                   Selinexor (KPT-
330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 104 of 105 
Confidential 
 
 INTERNATIONAL MYELOMA WORKING GROUP 
RESPONSE CRITERIA, MYELOMA 
International Myeloma Working Group Response Criteria, Myeloma (Kumar et al 
2016) 
Response Subcategory Response Criteria 
Stringent complete 
response (sCR) 
Complete response as defi ned below plus normal FLC ratio** and 
absence 
of 
clonal 
cells 
in 
bone 
marrow 
biopsy 
by 
immunohistochemistry (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ patients, 
respectively, after counting ≥100 plasma cells)†† 
Complete response 
(CR) 
Negative immunofixation on the serum and urine and disappearance of 
any soft tissue plasmacytomas and <5% plasma cells in bone marrow 
aspirates 
Very good partial 
response (VGPR) 
Serum and urine M-protein detectable by immunofi xation but not on 
electrophoresis or ≥90% reduction in serum M-protein plus urine M-
protein level <100 mg 
per 24 h 
Partial response (PR) 
≥50% reduction of serum M-protein plus reduction in 24 h urinary M-
protein by ≥90% or to <200 mg per 24 h; If the serum and urine M-
protein are unmeasurable, a ≥50% decrease in the difference between 
involved and uninvolved FLC levels is required in place of the M-
protein criteria; If serum and urine M-protein are unmeasurable, and 
serum-free light assay is also unmeasurable, ≥50% reduction in plasma 
cells is required in place of M-protein, provided baseline bone marrow 
plasma-cell percentage was ≥30%. In addition to these criteria, if 
present at baseline, a ≥50% reduction in the size (SPD)§§ of soft tissue 
plasmacytomas is also required. 
Minimal response 
(MR) 
≥25% but ≤49% reduction of serum M-protein and reduction in 24-h 
urine M-protein by 50–89%. In addition to the above listed criteria, if 
present at baseline, a ≥50% reduction in the size (SPD)§§ of soft tissue 
plasmacytomas is also required 
Stable disease (SD) 
Not recommended for use as an indicator of response; stability of 
disease is best described by providing the time-to-progression 
estimates. Not meeting criteria for complete response, very good partial 
response, partial response, minimal response, or progressive disease 
Progressive disease 
Any one or more of the following criteria:  Increase of 25% from 
lowest confi rmed response value in one or more of the following 
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Sherbenou                                                                                                                                   Selinexor (KPT-
330) 
IRB # 20-2202 
V5, 02JAN2025 
Page 105 of 105 
Confidential 
criteria:  Serum M-protein (absolute increase must be ≥0·5 g/dL); 
Serum M-protein increase ≥1 g/dL, if the lowest M component was ≥5 
g/dL; Urine M-protein (absolute increase must be ≥200 mg/24 h); In 
patients without measurable serum and urine M-protein levels, the diff 
erence between involved and uninvolved FLC levels (absolute increase 
must be >10 mg/dL); In patients without measurable serum and urine 
M-protein levels and without measurable involved FLC levels, bone 
marrow plasma-cell percentage irrespective of baseline status (absolute 
increase must be ≥10%); Appearance of a new lesion(s), ≥50% 
increase from nadir in SPD§§ of >1 lesion, or ≥50% increase in the 
longest diameter of a previous lesion >1 cm in short axis; ≥50% 
increase in circulating plasma cells (minimum of 200 cells per μL) if 
this is the only measure of disease 
 
Source: Shaji Kumar, Bruno Paiva, Kenneth C Anderson, Brian Durie, et al.  International 
Myeloma Working Group consensus criteria for response and minimal residual disease 
assessment in multiple myeloma.  Lancet Oncol 2016; 17: e328–46   
 
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Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 1 of 19
Principal Investigator:
Peter Forsberg, MD
COMIRB No:  20-2202
Version Date:  v4, 22NOV2022
Study Title:  Personalized Selinexor-based therapy for Relapsed/Refractory Multiple 
Myeloma
Key Information 
Please read all the information below and ask questions about anything you don’t understand 
before deciding if you want to take part. 
You are being asked to be in a research study. Participation in Research is voluntary. 
Purpose of the Study: We are doing this study to learn more about how selinexor (the study 
drug) treats multiple myeloma when taken with dexamethasone and one of three standard of care 
treatments:  pomalidomide, daratumumab, or carfilzomib. The study drug has not been FDA 
approved, and is therefore considered investigational.
Procedures: If you agree to participate, the following will happen: 
•
You will have a screening visit to make sure you are eligible to be in the study. This will 
include a bone marrow aspirate biopsy and a PET/CT scan.
•
If you are eligible and agree to participate, you will receive the study drug and 
dexamethasone in addition to standard treatment. 
•
You will visit the clinic on days 1, 8, 15, and 22 of each study cycle; each cycle lasts for 
28 days.
•
You may have a bone marrow aspirate or core biopsy during cycles 2 and 3 or at disease 
assessment.
•
Treatment will continue until your disease progresses or the study doctor determines that 
the study drug is no longer good for you.
•
After you stop taking the study drugs, you will be contacted by the study team every 3 
months to learn about any disease relapse and survival status.
Risks: Participation in research involves risks, including the following:
•
Risks associated with Selinexor may include: gastrointestinal problems; muscle pain or 
spasms; respiratory problems; sleep problems; weight loss; loss of energy; change in 
appetite or thirst; cognitive and neurological problems; skin or hair problems; peripheral 
edema; numbness and tingling; eye disorders; dry mouth or stomatitis; tachycardia; 
nosebleed; changes in levels of electrolytes, creatinine, pancreatic enzymes, liver 
enzymes, blood pressure, blood sodium, blood sugar, blood platelets, lymphocytes, red 
and white blood cells, aspartate aminotransferase, or blood alkaline; peripheral 
neuropathy; sepsis; tumor lysis syndrome; infections; cardiac failure, multiple organ 
dysfunction syndrome; encephalopathy; injury to kidney; pulmonary embolism; or hypoxia
COMIRB
APPROVED
For Use
22-Feb-2023
21-Jul-2023

Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 2 of 19
•
Risks associated with Dexamethasone may include: increased blood glucose or blood 
pressure; weight gain; skin or hair problems; edema; heartbeat irregularities; hormone 
imbalance; stomach ulcer; pancreatitis; muscle weakness; osteoporosis; headache; 
depression or emotional instability; impaired vision
•
Risks associated with bone marrow biopsy: A bone marrow biopsy may result in bleeding, 
infection, local nerve damage, pain from the needle sticks, and pain from aspirating the 
bone marrow with a syringe.
Benefits: There is no guarantee that your health will improve if you join this study. This study may 
lead to information that could help patients and health care providers in the future. 
Alternatives: There may be other ways of treating your type of cancer, and you may be able to 
receive other treatments without participating in this study. Please discuss other treatment options 
with your doctor.
Detailed Consent
Why is this study being done?
This study plans to learn more about how the study drug, Selinexor, in combination with other 
standard of care drugs might work to treat multiple myeloma.  The combination standard of care 
drugs include Pomalidomide, Dexamethasone, Daratumumab, Carfilzomib.
You are being asked to take part in this study because you have been diagnosed with multiple 
myeloma, a cancer of the plasma cells (a type of immune cell that produces antibodies) which 
has returned after your most recent treatment regimen (relapsed) or has not responded to your 
most recent treatment regimen (refractory). The purpose of this research study is to see if 
Selinexor (also known as KPT-330) and the drug combinations have any effect against your 
cancer. This study drug combinations with Selinexor are considered investigational, which means 
the combination has not been approved by the U.S. Food and Drug Administration (FDA), Health 
Canada, the European Medicines Agency (EMA) or any other national competent authority. The 
proposed Selinexor combinations of therapy (SPd, SKd and SDd) regimens are investigational 
and not approved therapy for RRMM.  Other approved regimens with known benefits are available 
for your condition.
Cancer is the uncontrolled growth of human cells. The growth of normal human cells is controlled 
by multiple mechanisms. Cancer cells can escape one or more of these control mechanisms 
leading to uncontrollable growth. One specific way cancer cells continue to grow is by getting rid 
of certain proteins called “tumor suppressor proteins” that would normally cause cancer cells to 
die.  
Selinexor works by trapping “tumor suppressing proteins” within the cell and thus causing the 
cancer cells to die or stop growing.  
Selinexor has previously been tested in humans to define a safe dose to be administered. It is not 
known at this time if it will treat your cancer. Selinexor is currently being tested in other clinical 
trials in patients with advanced cancers. This study will examine its effects on your cancer and on 
your body including any side effects that you may experience.  

Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 3 of 19
Your participation in this study is voluntary. You may decide to not take part or to withdraw from 
the study at any time without losing any benefit of your current care.
Other people in this study
Up to 18 people from your area will participate in the study. 
What happens if I join this study?
If you join the study, you will be asked to sign this consent form. You will be given a copy to keep 
and the original form will be kept at the clinic. You can withdraw from the study at any time and 
without giving a reason. This will not affect the standard medical care you receive. 
There are 3 parts to the study: 
1.
Screening 
2.
Treatment 
3.
Follow Up  
The next section of this form lists what will be expected of you if you join this study. 
Study Procedures
While you are taking part in this study, some of the tests and procedures are the same type that 
would be performed as part of your regular cancer care even if you did not join the study. Some 
of the tests and procedures are required only for the study and are considered research 
procedures.  Research procedures cannot be conducted before this consent form is signed.
The screening tests and procedures will be done to see if you are eligible to join this study. You 
may have had some of these tests and procedures done recently as standard care for your 
cancer, and they may not need to be repeated. 
Screening Phase (within 28 days before treatment)
•
Informed consent 
•
Review of medical history 
•
Review of medications 
•
Physical exam, including weight and vital signs 
•
Disease status 
•
Blood draw for routine tests 
•
Pregnancy test, for women of child-bearing age (blood or urine) 
•
Counseling on the risks of pregnancy while in this study 
•
Bone marrow aspiration and biopsy 
•
Electrocardiogram (EKG) 
•
PET/CT scan
After screening is completed and the study doctor agrees that you can continue with the study, 
you will begin the study treatment.

Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 4 of 19
Study Treatment Phase
You are expected to to have the following visits and procedures during this study:
•
You will visit the clinic on the following days
o
Cycle 1 – days 1, 8, and 15
o
Cycle 2 - days 1 and 15
o
Cycle 3+ - day 1
o
End of Treatment
•
Weight (Day 1 of each 28-day cycle and end of treatment)
•
Vital signs (blood pressure, pulse, and temperature)
•
Symptom directed Physical Examinations
•
Laboratory assessments, including bloodwork 
•
Multiple myeloma assessments 
•
Quality Of Life Questionnaire
•
Study drug: Selinexor and Dexamethasone in combination with your clinically-assigned 
standard of care medication. For each cycle, all subjects will receive Selinexor (for 3 
weeks) and Dexamethasone (for one month) weekly. Additionally:
o
Arm 1: Subjects will receive Pomalidomide daily (for 3 weeks). 
o
Arm 2: Subjects will receive Daratumumab weekly during cycles 1 and 2, every 
two weeks during cycles 3-6, and only once during any subsequent cycles. 
o
Arm 3: Subjects will receive Carfilzomib weekly (for 3 weeks). 
Study Follow Up
When you have completed the treatment part of the study, you will begin study follow up.
The follow-up part of the study includes contact from the study team to discuss and record any 
relapse of your cancer, any new anti-cancer therapy and survival status.  The study team will follow 
up with you via health portal, email, or phone every 3 months for a minimum of two years.
What are the possible discomforts or risks?
Discomforts you may experience while in this study are indicated below. In addition to these, there 
may be other unknown risks, or risks that we did not anticipate, associated with being in this study. 
Some risks described in this consent document, if severe, may cause death. 
Side Effects of Selinexor
Very common side effects ( ≥10%): 
In 100 people with hematologic malignancies receiving Selinexor more than 10 people may 
have: 
•
nausea 
•
low platelets in the blood (thrombocytopenia), which may increase the risk of bleeding
•
fatigue 

Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 5 of 19
•
decreased appetite 
•
decrease in red blood cells (anemia) causing fatigue 
•
diarrhea 
•
vomiting 
•
weight loss
•
decrease in neutrophils (a type of white blood cell that helps fight infections) 
•
constipation 
•
low blood sodium which may increase the risk of seizures 
•
cough 
•
shortness of breath 
•
fever 
•
loss of energy; weakness 
•
dizziness 
•
peripheral edema – swelling in extremities due to accumulation of fluid, usually in legs 
•
decrease in white blood cells (leukopenia), which may increase the risk of infection 
•
blurred vision 
•
low potassium which may cause weakness, muscle cramps and spasms 
•
peripheral neuropathy – weakness, numbness, and pain from nerve damage, usually 
in the hands and feet 
•
change in taste (dysgeusia)
•
difficulty falling asleep 
•
upper respiratory tract infection
•
abdominal pain 
•
back pain
•
dehydration 
•
pneumonia 
Common serious side effects (≥1 - <10%): 
In 100 people receiving selinexor about 1 to 10 people may have: 
•
febrile neutropenia
•
sepsis (including septic shock) potentially life-threatening complication of an infection 
headache 
•
high blood sugar which may cause fatigue, increased thirst/hunger, frequent urination, 
weight loss, numbness and tingling in hands/feet 
•
acute kidney injury
•
fainting
•
confusion
•
cognitive disorder
•
respiratory failure
•
rash 
•
cataract (new or worsened) 
•
syncope
•
night sweats 
•
dry mouth 
•
stomatitis – a condition that causes painful swelling and sores inside the mouth 
•
dyspepsia – indigestion 
•
chills 

Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 6 of 19
•
hypotension – low blood pressure 
•
hypertension
•
tachycardia – fast heart rate 
•
nosebleed 
•
contusion (bruise due to body injuries such as fall) 
•
electrolyte disturbances including: 

low phosphate which may cause muscle weakness and fatigue 

low magnesium which may cause muscle twitches and cramps 

low calcium which may cause numbness and tingling in hands/feet/face, muscle 
stiffness and cramps 

high potassium which may cause muscle weakness, palpitations or irregular 
heartbeats and chest pain 
•
low albumin (which may cause swelling especially of the hands/feet, weakness or 
exhaustion) 
•
decrease in lymphocytes – a specific type of white blood cell that are part of your 
immune system 
•
increase of creatinine in the blood due to a reduction in kidney function, often related 
to dehydration 
•
elevated liver enzymes including alanine aminotransferase increased, aspartate 
aminotransferase increased, blood alkaline phosphatase increased 
•
elevated pancreatic enzymes including high amylase and high lipase 
•
muscle weakness 
•
pain in joints and muscles 
•
malaise (a general feeling of being ill or bodily weakness) 
•
muscle spasms 
•
hair loss 
•
itching 
•
depression
Uncommon serious side effects (>0.1 - 1%): 
In 1,000 people receiving selinexor about 1 to 10 people may have: 
•
cardiac disorders
•
urinary tract infection 
•
gait disturbance 
•
loss of blood flow to part of the brain 
•
pulmonary blood clot stuck in an artery in the lungs, blocking the flow of blood 
(pulmonary embolism)
•
bleeding between the brain tissue and skull or within the brain
•
buildup of fluid between the layers of tissue that line the lungs and chest cavity (pleural 
effusion)
•
accumulation of fluid in the peritoneal cavity, causing abdominal swelling 
•
pancreatitis

Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 7 of 19
Dexamethasone: increased blood glucose, increased blood pressure, weight gain, skin thinning, 
edema, heartbeat irregularities, hair loss, hormone imbalance, stomach ulcer, pancreatitis, 
muscle weakness, osteoporosis, headache, depression or emotional instability, impaired vision, 
worsening cataracts.
Possible Risks Associated with Daratumumab 
Not all of the possible side effects and risks related to daratumumab are known. Daratumumab 
can cause side effects, although not everybody gets them.
Very common side effects with daratumumab (may affect more than 1 in 10 patients): 
•
fever
•
feeling very tired
•
flu
•
diarrhea
•
headache
•
nerve damage that may cause tingling, numbness, or pain
•
high blood pressure
•
muscle spasms
•
swollen hands, ankles and feet
•
lung infection (pneumonia)
•
infections of the airways - such as nose, sinuses or throat
•
low number of white blood cells which help fight infections (neutropenia, 
lymphopenia)
•
low number of a type of blood cell called platelets, which help to clot blood 
(thrombocytopenia)
•
low number of red blood cells which carry oxygen in the blood (anemia)
•
Eye pain
Common (may affect up to 1 in 10 patients):
•
Irregular heartbeat (atrial fibrillation)
•
buildup of fluid in the lungs making you short of breath
Uncommon (may affect 1 in 1,000 patients):
•
inflamed liver (hepatitis)
Infusion-related reactions - A side effect to daratumumab that occurs during or shortly after an 
infusion is completed (when the medicine is given into a vein) is called an infusion-related 
reaction. 
Tell your doctor right away if you get any of the following signs of an infusion-related reaction 
during or in the 3 days after the infusion. You may need other medicines, or the infusion may 
need to be slowed down or stopped. When these reactions go away, or get better, the infusion 
can be started again.
Very common (may affect more than 1 in 10 patients):
•
chills
•
sore throat, cough
•
feeling sick (nausea)

Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 8 of 19
•
vomiting
•
itchy, runny or blocked nose
•
cough
•
feeling short of breath or other breathing problems
•
blurred vision
Other common symptoms (affects up to 1 in 10):
•
chest discomfort
•
dizziness or lightheadedness (hypotension)
•
itching
•
wheezing
If you get any of the infusion-related reactions above, tell your doctor right away. These reactions 
are most likely to happen with the first infusion. If you have had an infusion-related reaction once 
it is less likely to happen again. Your doctor may decide not to use daratumumab if you have a 
strong infusion reaction. 
Before each infusion of daratumumab you will be given medicines, which help to lower the chance 
of infusion-related reactions. These may include:
•
anti-histamines (for an allergic reaction)
•
corticosteroids (for inflammation)
•
acetaminophen (for fever)
If you have breathing problems such as chronic obstructive pulmonary disease (COPD) or 
asthma, you will be given medicines to inhale which help your breathing problems:
•
bronchodilators to help the airways in your lungs to stay open
•
corticosteroids to lower swelling and irritation in your lungs
Decreased blood cell counts - Daratumumab can decrease white blood cell counts which help 
fight infections and platelets which help to clot blood. Tell your doctor if you develop fever or if 
you have signs of bruising or bleeding. 
Blood transfusions - If you need a blood transfusion, you will have a blood test first to match 
your blood type. Daratumumab can affect the results of this blood test. Tell the person doing the 
test that you are using daratumumab. Your study doctor will provide you with additional 
information about the risks and side effects, including rare side effects, of daratumumab.
Possible Risks Associated with Pomalidomide 
Pomalidomide has been studied in healthy volunteers and in subjects with cancer of the blood 
and other organs of the body as well as in subjects with other diseases. As with any other 
experimental treatment there may be side effects or risks that are unknown or cannot be predicted 
at this time, but you will be carefully monitored for any problems and you are encouraged to report 
anything that is bothering you to your study doctor or nurse.
The following is a list of important side effects reported with pomalidomide. In some cases, side 
effects can be serious, long-lasting, may never go away, or can cause death. The study doctor 
may give you medicines to help lessen the side effects. Some side effects go away soon after 
you stop the study drug. This is not a complete list of all side effects but your study doctor will 
answer any questions you might have and can provide you with more information.

Consent and Authorization Form 
IRB #20-2202
V4, 22NOV2022
Page 9 of 19
Very common (greater than 10% chance this may happen): Infections including: Infection of 
the lungs (influenza, pneumonia, respiratory tract infection), inflammation of airways of lungs 
caused by infection (bronchitis), infection of the bladder or kidneys (urinary tract infection), 
dizziness, nausea and vomiting, changes in sensations including decreased sense of touch, 
burning sensation, tingling (peripheral neuropathy), abnormal shaking (tremor),  abnormal levels 
of blood electrolytes, including: low blood level of sodium (hyponatremia), high blood level of 
calcium (hypercalcemia), low blood level of calcium (hypocalcemia), low blood level of potassium 
(hypokalemia), rash, confusion (confusional state), unable to sleep (insomnia), decreased kidney 
function (renal failure), itching (pruritus), decrease in platelets, the cells that help your blood to 
clot (thrombocytopenia), Gastrointestinal disorders, including: changes in bowel movement 
(constipation, diarrhea), cough, decrease in red blood cells carrying oxygen to your body 
(anemia), loss of appetite (decreased appetite), high levels of sugar in the blood (hyperglycemia), 
fever (pyrexia), Abnormal levels of blood cells, including: decrease in white blood cells 
(leukopenia, neutropenia lymphopenia) which help fight infection, muscle cramp (muscle 
spasms), bone pain, back pain, decreased strength in the muscles (muscular weakness), 
shortness of  breath (dyspnoea), swelling including arms and legs (edema peripheral), and 
tiredness (fatigue).
Common (between a 1-10% chance that this may happen): Severe life-threatening infection 
may include possible low blood pressure, kidney failure, and/or heart failure (neutropenic sepsis, 
sepsis, septic shock), serious infection resulting in diarrhea and inflammation of the lower intestine 
(clostridium difficle colitis), rapid, irregular heart beat (atrial fibrillation), lightheadedness, loss of 
balance (vertigo), condition in which the lens of the eye becomes cloudy (cataract), feeling of 
fullness and tightness in the abdomen (abdominal distention), pain in the abdomen (abdominal 
pain), dry mouth; mouth sores (stomatitis), build-up of fluid in the body causing swelling (edema), 
non-cardiac chest pain, sore throat (nasopharyngitis), Abnormal levels of blood electrolytes, 
including: high blood level of potassium (hyperkalemia), low blood level of magnesium 
(hypomagnesemia), low blood level of phosphate (hypophosphatemia), walking/balance 
problems (fall), abnormal liver lab test (alanine aminotransferase increased), weight decreased, 
less alert (depressed level of consciousness), abnormal taste (dysgeusia), temporary loss of 
consciousness (syncope), depression, blood clots in legs or lungs (pulmonary embolism, deep 
vein thrombosis), high blood pressure (hypertension), low blood pressure (hypotension), difficulty 
in passing urine (urinary retention), decrease in red blood cells, white blood cells, and platelets 
(pancytopenia), low number of white blood cells with fever (febrile neutropenia) and pelvic pain.
Uncommon (between 0.1- 1% chance that this may happen): Elevated blood levels of bilirubin 
(hyperbilirubinemia).
Other Important Side Effects
Events that do not meet the criteria for inclusion above but are also considered important enough 
for you to be made aware: 
•
New Cancer: second primary malignancies (SPMs) are new cancers that are 
diagnosed in subjects following a prior diagnosis of a first cancer. 
•
Pneumonitis, Interstitial Lung Disease: Inflammation of your lungs. 
•
Tumor lysis syndrome: rapid death of cancer cells where the accumulating contents of 
dying cancer cells cause an imbalance in the chemistry of the body which can lead to 
kidney damage. 
•
Hepatoxicity: liver injury and/or abnormal liver tests, this may cause jaundice (yellow 
skin).
•
Severe allergic conditions including:

Swelling under skin (Angioedema)

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
Severe skin reactions involving lining of the nose, mouth, stomach and intestines 
or rash leading to the separation of the top layer of skin [Stevens-Johnson 
syndrome (SJS) and Toxic epidermal necrolysis (TEN), respectively]

A skin reaction [such as rash or skin peeling (exfoliative dermatitis)], elevated level 
of eosinophils (eosinophilia), fever, and/or swollen glands (lymphadenopathy) with 
other organ complications such as inflammation of the liver (hepatitis), 
inflammation of the kidney nephrons (nephritis), inflammation of the lungs 
(pneumonitis), inflammation of the heart (myocarditis), and/or inflammation of the 
sac surround the heart (pericarditis) [Drug reaction with eosinophilia and systemic 
symptoms (DRESS)]
•
Cardiac failure: heart problems which can cause shortness of breath and/or ankle 
swelling.
•
Hepatitis B virus reactivation: a reactivation of the hepatitis B virus in patients who 
have previously been infected with hepatitis B.  The reactivation can lead to serious 
liver injury.
•
Herpes zoster: also called shingles, causes a rash with blisters on the body and is very 
painful.
•
Gastrointestinal hemorrhage: bleeding that starts in the lining of the stomach or 
intestines which may cause dark, bloody stool, large amounts of blood passed from 
the rectum or in streaks on feces, and vomiting of blood.
•
Basal cell carcinoma: A type of skin cancer that can have many different appearances: 
a red patch or irritated area; a small, pink pearly bump; a white or yellow scar-like area; 
a smooth growth with a dent in the center; or an open sore that bleeds or oozes and 
most commonly found on the face, neck, hands, or other parts of the body that are 
frequently exposed to the sun. 
•
Squamous cell carcinoma of the skin: is an uncontrolled growth of abnormal skin cells 
arising mostly the on the skin’s upper layers (the epidermis).  The growth often looks 
like scaly red patches, open sores, elevated growths with a central depression, or 
warts; they may crust or bleed. They can become disfiguring and sometimes deadly if 
allowed to grow.
Additional Important Precautions
Other than the subject, females who are able to become pregnant and males who are able to 
father a child, should not touch or handle the pomalidomide capsules or the powder they contain. 
We do not know if pomalidomide has any effect on your being able to have a child in the future, 
please speak with your doctor about family planning options for the future.
Please let your Study Doctor know all of your present and past diseases and allergies and any 
medication you may be taking including over-the-counter medications, vitamins, herbal, 
homeopathic or holistic medications or treatments. This is important because a possible 
interaction with some medications, vitamins, and remedies may cause serious side effects, and/or 
may still be unknown.
Possible Risks Associated with Carfilzomib
Not all of the possible side effects and risks related to carfilzomib are known. Carfilzomib can 
cause side effects, although not everybody gets them.
Some side effects could be serious. Tell your doctor straight away if you get or notice any 
of the following symptoms:

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•
Chest pains, shortness of breath, or if there is swelling of your feet, which may be 
symptoms of heart problems
•
Difficulty breathing, including shortness of breath at rest or with activity or a cough 
(dyspnoea),
•
rapid breathing, feeling like you can't breathe in enough air, wheezing, or cough, which 
can be signs of lung toxicity
•
Very high blood pressure, severe chest pain, severe headache, confusion, blurred vision, 
nausea and vomiting, or severe anxiety, which may be signs of a condition known as 
hypertensive crisis
•
Shortness of breath with everyday activities or at rest, irregular heartbeat, racing pulse, 
tiredness, dizziness, and fainting spells, which can be signs of a condition known as 
pulmonary hypertension
•
Swollen ankles, feet or hands, loss of appetite, passing less urine, or abnormal blood test 
results, which may be symptoms of kidney problems or kidney failure
•
A side effect called tumour lysis syndrome, which can be caused by the rapid breakdown 
of tumour cells and may cause irregular heartbeat, kidney failure or abnormal blood test 
results
•
Fever, chills or shaking, joint pain, muscle pain, facial flushing or swelling, weakness, 
shortness of breath, low blood pressure, fainting, chest tightness, or chest pain can occur 
as a reaction to the infusion
•
Unusual bruising or bleeding, such as a cut, that takes longer than usual to stop bleeding; 
or internal bleeding such as coughing up blood, vomiting up blood, dark tarry stools, or 
bright red blood in your stools; or bleeding in the brain leading to sudden numbness or 
paralysis on one side of the face, legs or arms, sudden severe headache or trouble seeing 
or difficulty speaking or swallowing
•
Leg or arm pain or swelling (which could be a symptom of blood clots in the deep veins of 
the leg or arm), chest pain or shortness of breath (which may be a symptom of blood clots 
in the lungs)
•
Yellowing of your skin and eyes (jaundice), abdominal pain or swelling, nausea or 
vomiting, which could be symptoms of liver problems including liver failure
•
Bleeding, bruising, weakness, confusion, fever, nausea, vomiting and diarrhoea, and 
acute kidney failure, which may be signs of a blood condition known as thrombotic 
microangiopathy
•
Headaches, confusion, seizures (fits), visual loss, and high blood pressure (hypertension), 
which may be symptoms of a neurologic condition known as posterior reversible 
encephalopathy syndrome (PRES).
Other possible side effects
Very common side effects (may affect more than 1 in 10 patients): serious lung infection 
(pneumonia), respiratory tract infection (infection of the airways), low platelets, which may cause 
easy bruising or bleeding (thrombocytopenia), low white blood cell count, which may decrease 
your ability to fight infection and may be associated with fever, low red blood cell count (anaemia) 
which may cause tiredness and fatigue, changes to blood tests (decreased blood levels of 
potassium, increased blood levels of sugar and/or creatinine), decreased appetite, difficulty 
sleeping (insomnia), headache, numbness, tingling, or decreased sensation in hands and/or feet, 
dizziness, high blood pressure (hypertension), shortness of breath, cough, diarrhoea, nausea, 
constipation, vomiting, stomach pain, back pain, joint pain, pain in limbs, hands or feet, muscle 
spasms, fever, chills, swelling of the hands, feet or ankles, feeling weak, tiredness (fatigue).

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Common side effects (may affect up to 1 in 10 patients): infusion reaction, heart failure and 
heart problems including rapid, strong or irregular heartbeat, heart attack, kidney problems, 
including kidney failure, blood clots in the veins (deep vein thrombosis), feeling too hot, blood clot 
in the lungs, fluid in the lungs, wheezing, serious infection including infection in the blood (sepsis), 
lung infection, liver problems including an increase in liver enzymes in the blood, flu-like 
symptoms (influenza), reactivation of the chicken pox virus (shingles) that can cause a skin rash 
and pain (herpes zoster), urinary tract infection (infection of structures that carry urine), cough 
which could include chest tightness or pain, nasal congestion (bronchitis), sore throat, 
inflammation of the nose and throat, runny nose, nasal congestion or sneezing, viral infection, 
infection of the stomach and intestine (gastroenteritis), bleeding in the stomach and bowels, 
changes to blood tests (decreased blood levels of sodium, magnesium, protein, calcium or 
phosphate, increased blood levels of calcium, uric acid, potassium, bilirubin or c-reactive protein), 
dehydration, anxiety, feeling confused, blurred vision, cataract, low blood pressure (hypotension), 
nose bleed, change in voice or hoarseness, indigestion, toothache, rash, bone pain, muscle pain, 
chest pain, muscle weakness, aching muscles, itchy skin, redness of the skin, increased 
sweating, pain, pain, swelling, irritation or discomfort where you received the injection into your 
vein, ringing in the ears (tinnitus), a general feeling of illness or discomfort
Uncommon side effects (may affect up to 1 in 100 patients): bleeding in the lungs, 
inflammation of the colon caused by a bacteria called Clostridium difficile, allergic reaction to 
carfilzomib, multi-organ failure, reduced blood flow to the heart, bleeding in the brain, stroke, 
difficulty breathing, rapid breathing and/or fingertips and lips looking slightly blue (acute 
respiratory distress syndrome), swelling of the lining of the heart (pericarditis), symptoms include 
pain behind the breast bone, sometimes spreading across to the neck and shoulders, sometimes 
with a fever, fluid build-up in the lining of the heart (pericardial effusion), symptoms include chest 
pain or pressure and shortness of breath, a blockage in the flow of bile from the liver (cholestasis), 
which can cause itchy skin, yellow skin, very dark urine and very pale stools, perforation of the 
digestive system, a central nervous system infection known as progressive multifocal 
leukoencephalopathy (PML), hepatitis B virus (HBV) reactivation.
Other possible risks
Risks Associated with Pregnancy
While participating in this research study, you should not become pregnant, nurse a baby, or 
father a baby.  Both men and women who are able to have children must use a highly effective 
means of birth control approved by your study doctor.  You must continue the use of birth control 
at least 28 days before starting study drugs, during the entire time of your study participation and 
to at least 6 months after the last dose of study drugs.
If you are a female who has stopped having menstrual periods for at least 1 year (menopause), 
please discuss with your study doctor the need for birth control.  If you become pregnant, you 
must stop taking selinexor at once and notify your doctor immediately.  You will not be allowed to 
continue in the study.  You may be asked questions about the outcome of your pregnancy and 
the baby. 
If you are a male, you are responsible for informing your partner(s) that the effects of selinexor on 
an unborn fetus or embryo in humans are unknown.  You and your partner(s) are responsible for 
using acceptable birth control as described above.  Discuss with your partner acceptable forms 
of contraception.  If your partner becomes pregnant while you are on study, you must notify your 
doctor immediately.  You and your partner may be asked questions about the outcome of the 
pregnancy and the baby.  Written informed consent for release of medical information from your 
partner will be obtained prior to collecting any information about the pregnancy and baby.  

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Risk of Loss of Confidentiality
There is a risk that people outside the research team will see your research information. We will 
do all that we can to protect your information, but it cannot be guaranteed.
There may be other risks that could arise which are not reasonably foreseeable. If new information 
becomes available which could influence your willingness to continue, this new information will 
be discussed with you.
Risks Associated with Study Procedures
Risks of Having Blood Taken
In this study we will need to get about between 3-10 teaspoons of blood from you in a visit. We 
will get blood by putting a needle into one of your veins and letting the blood flow into a tube.  You 
may feel some pain when the needle goes into your vein.  A day or two later, you may have a 
small bruise where the needle went under the skin. 
Risks of Having an IV Inserted In Your Vein
In this study, we may insert a needle, connected to a plastic tube, into a vein.  We will use the 
tube to take blood samples or give you fluids.  You will feel some pain when we first insert the 
tube into your vein.  You may have some redness, swelling, or bruising where the tube goes under 
your skin.  In some cases, this type of tube can cause an infection where it goes under the skin.  
In rare cases, it can cause a blood clot in the vein.  You will have this tube inserted for up to 12-
24 hours.
Risks of Bone Marrow Aspirate / Biopsy
The risks of this procedure are small and include bleeding, infection, local nerve damage, pain 
from the needle sticks, and pain from aspirating the bone marrow with a syringe. This study may 
require that two biopsy cores are collected.  The additional risk of the second biopsy core is 
minimal, though you may experience additional discomfort when the second biopsy core is 
obtained.  Care will be taken to avoid these complications.
Risks of an ECG
You may have itching or bruising of the skin where the machine patches are placed for the ECG.
Risks of an Echocardiogram (ECHO)
ECHO is a noninvasive scan of the heart using sound waves.  This test will be used to see how 
well your heart pumps blood.  This test has no known risks or side effects.
Risks of Computed Tomography (CT) Scan
As part of this study we may perform a CT scan of your brain, chest, and abdomen.  Additional 
areas of your body may be scanned if your doctor decides it is necessary to assess your disease.  
CT is a way of taking detailed pictures inside your body by using X-rays.  X-rays are a type of 
radiation.

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You get some radiation from your environment.  You get radiation from bricks and concrete, from 
some foods, and from radon gas, which is an invisible gas that seeps out of the ground.  The 
amount of radiation that this CT scan will deliver to your body (give you) is about the same as you 
would get from living in your environment for 6 years.
This is an estimate.  The amount of radiation you get could be higher or lower, depending on the 
machine, the power setting, and your body weight. Exposure to radiation at high levels increases 
a risk of developing cancer. There is no evidence of such risks for diagnostic procedures. 
The risk of this procedure is not equal for everyone.  The risk is much higher for unborn 
babies if the mother has this procedure.  The risk is also much higher for young children 
and teenagers.  The risk is much lower for people over the age of 30.
Risks of Positron Emission Tomography (PET) Scan
There is a chance that you may experience discomfort, pain, or swelling at the site where the 
radiotracer is injected. There may be a risk of having an allergic reaction to the radiotracer FDG 
chemical. However, this reaction has been rarely observed. The amount of radiation to your body 
is small and the radiation from the radiotracer will be gone from your body in a few hours.
Risks of Magnetic Resonance Imaging (MRI)
In this study we may take Magnetic Resonance Images (MRI’s) of your brain, chest, and 
abdomen.  Additional areas of your body may be scanned if your doctor decides it is necessary 
to assess your disease.  The MRI machine uses powerful magnetic waves to take pictures inside 
the body.  The waves themselves are not harmful, but they can cause metal to heat up and 
electronics to stop working.  
You should NOT have an MRI if you have metal or electronic devices inside your body.  
Heart pacemakers and insulin pumps are examples of electronic devices.
The MRI machine is a small round tube.  It might make you uncomfortable if you do not like tight 
spaces.  
The most common side effect of having an MRI is flashing lights in the eyes.  This is caused by 
the magnetic waves and is not harmful.  Some people also experience warmth and reddening of 
the skin.  This usually goes away after a few minutes.
If you are pregnant, be sure to tell the person giving you the MRI.
There is a risk that people outside of the research team will see your research information.  We 
will do all that we can to protect your information, but it cannot be guaranteed.
If you become pregnant, the particular treatment or procedures involved in the study may 
involve risks to the embryo or fetus, which are currently unclear
The study may include risks that are unknown at this time. 

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What are the possible benefits of the study?
This study is designed for the researcher to learn more about the effect Selinexor has on those 
diagnosed with multiple myeloma.
This study is not designed to treat any illness or to improve your health. If you agree to take part 
in this study, there may or may not be direct medical benefit to you.  While it is possible that you 
may benefit, we do not know if you will and there is no guarantee of this.  We hope the information 
learned from this study will benefit other individuals with Multiple Myeloma in the future.  
Are there alternative treatments? 
There may be other ways of treating your cancer. Instead of taking part in this study:
•
You may choose to receive treatment with an approved therapy.
•
You may choose to participate in a different study with another experimental drug.
•
You may choose to receive comfort/ palliative care.
•
You may choose to get no treatment at all.
You should talk to your doctor about your choices. Make sure you understand all of your choices 
before you decide to take part in this study. You may leave this study and still have these other 
choices available to you. 
Who is paying for this study? 
Karyopharm Therapeutics Inc. is providing funding support for this study. Karyopharm 
Therapeutics Inc. manufactures the study drug, Selinexor, and will provide this drug for the study.  
This research is being conducted by Dr. Peter Forsberg. The research study will only pay for 
procedures not considered standard of care.
Karyopharm Therapeutics is providing funding support for this research study.  Please feel free 
to ask any questions you may have about this matter.
Will I be paid for being in the study?  
You will not be paid to be in the study. 
Will I have to pay for anything?
The drug manufacturer, Karyopharm, will pay for the cost of the study drug, Selinexor. The funding 
for this study will also pay for any tests or procedures that are not considered standard of care. 
The other drugs are considered standard treatment for your type of cancer. These drugs will be 
obtained through your insurance, and you will be responsible for any applicable copays required 
by your insurance policy.  These drugs include Pomalidomide, Dexamethasone, Daratumumab, 
Carfilzomib.
There are some medical procedures that you would get for your condition whether you were in 
this study or not, such as blood draws. These are considered standard of care. You and/or your 
health insurance may be billed for the costs of medical care during this study, if these expenses 

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are related to standard of care procedures. If you have health insurance, the cost of these services 
will be billed to your insurance company. If your insurance does not cover these costs, or you do 
not have insurance, these costs will be your responsibility. 
Ask your study doctor to discuss the costs that will or will not be covered by this research study. 
This discussion should include the costs of treating possible side effects. Otherwise, you might 
have unexpected expenses from being in this study.
Is my participation voluntary?
Taking part in this study is voluntary.  You have the right to choose not to take part in this study.  
If you choose to take part, you have the right to stop at any time.  If you refuse or decide to 
withdraw later, you will not lose any benefits or rights to which you are entitled. 
If you leave this study, you will still receive your normal medical care.  The only medical care that 
you will lose is the medical care you are getting as part of this study.  You might be able to get 
that same kind of medical care outside of the study.  Ask your study doctor. 
Can I be removed from this study? 
The study doctor may decide to stop your participation without your permission if the study doctor 
thinks that being in the study may cause you harm, or for any other reason. 
 
What happens if I am injured or hurt during the study? 
If you have an injury while you are in this study, you should call Dr. Forsberg immediately. His 
phone number is 720-848-9307.
We will arrange to get you medical care if you have an injury that is caused by this research.  
However, you or your insurance company will have to pay for that care. 
Who do I call if I have questions?
The researcher carrying out this study is Peter Forsberg, MD. You may ask any questions you 
have now. If you have questions, concerns, or complaints later, you may call Dr. Forsberg at 720-
848-9307. You will be given a copy of this form to keep.  
You may have questions about your rights as someone in this study. You can call Dr. Forsberg 
with questions.  You can also call the responsible Institutional Review Board (COMIRB).  You can 
call them at 303-724-1055. 
A description of this clinical trial will be available on http://www.Clinical Trials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time.
Who will see my research information?
The University of Colorado Denver | Anschutz Medical Campus (the University) and its affiliated 
hospital(s) have rules to protect information about you.  Federal and state laws including the 
Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy.   This part 
of the consent form tells you what information about you may be collected in this study and who 
might see or use it.  

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The institutions involved in this study include:
•
University of Colorado Denver | Anschutz Medical Campus
•
University of Colorado Health
We cannot do this study without your permission to see, use and give out your information.  You 
do not have to give us this permission.  If you do not, then you may not join this study.  
We will see, use and disclose your information only as described in this form and in our Notice of 
Privacy Practices; however, people outside the UCD and its affiliate hospitals may not be covered 
by this obligation.
We will do everything we can to maintain the confidentiality of your personal information but 
confidentiality cannot be guaranteed. 
The use and disclosure of your information has no time limit.  You can cancel your permission to 
use and disclose your information at any time by writing to the study’s Principal Investigator (PI), 
at the name and address listed below.  If you do cancel your permission to use and disclose your 
information, your part in this study will end and no further information about you will be collected.  
Your cancellation would not affect information already collected in this study.  
Peter Forsberg, MD
Anschutz Medical Campus
1665 N. Aurora Court
Mail Stop F754
Aurora, CO 80045
Both the research records that identify you and the consent form signed by you may be looked at 
by others who have a legal right to see that information, such as:
  
•
Federal offices such as the Food and Drug Administration (FDA) and the Office of Human 
Research Protections (OHRP) that protect research subjects like you.
•
People at the Colorado Multiple Institutional Review Board (COMIRB).
•
The study doctor and the rest of the study team.
•
Members of your care team that have access to your electronic medical records.
•
Karyopharm Therapeutics Inc., manufacturer of Selinexor who is also providing funding 
support.  
•
Officials at the institution where the research is conducted and officials at other institutions 
involved in this study who are in charge of making sure that we follow all of the rules for 
research.
We might talk about this research study at meetings.  We might also print the results of this 
research study in relevant journals.  But we will always keep the names of the research subjects, 
like you, private. 
You have the right to request access to your personal health information from the Investigator. 
Information about you that may be seen, collected, used or disclosed in this study: 
•
Name and demographic information (age, sex, ethnicity, address, phone number, etc.

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•
Portions of your previous and current medical records that are relevant to this study, 
including but not limited to diagnosis(es), history and physical, laboratory or tissue studies, 
radiology studies, procedure results.
•
Research visit and research test records.
•
Tissue samples and the data with the samples. 
•
Billing or financial information.
Your care team, including family doctor, may be made aware of your participation in the study 
through your electronic medical records.
What happens to Data, Tissue, Blood and Specimens that are collected in this study? 
Scientists at the University of Colorado Denver and the hospitals involved in this study work to 
find the causes and cures of disease.  The data, tissue, blood and specimens collected from you 
during this study are important to this study and to future research.  If you join this study:
•
The data, tissue, blood, or other specimens given by you to the investigators for this 
research no longer belong to you.  
•
Both the investigators and any sponsor of this research may study your data, tissue, 
blood, or other specimens collected from you.
•
If data, tissue, blood, or other specimens are in a form that identifies you, UCD or the 
hospitals involved in this study may use them for future research only with your 
consent or Institutional Review Board (IRB) approval.
•
Any product or idea created by the researchers working on this study will not belong 
to you.
•
There is no plan for you to receive any financial benefit from the creation, use or sale 
of such a product or idea. 
The data we collect will be used for this study but may also be important for future research. Your 
data may be used for future research or distributed to other researchers for future study without 
additional consent if information that identifies you is removed from the data.

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