Clinical trial NCT04191616
Conditions: Relapsed or Refractory Multiple Myeloma
Keywords: Multiple Myeloma RRMM Open-label First Relapse Multiple Myeloma Second Relapse Multiple Myeloma Refractory to Lenalidomide Triplicate Treatment Regimen Dexamethasone Carfilzomib Pomalidomide
Sponsor: Amgen
Start date: 2020-08-06; Completion date: 2024-10-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone

Detailed description:
An Open-label, Phase 2 Study Treating Subjects with First or Second Relapse of Multiple Myeloma with Carfilzomib, Pomalidomide, and Dexamethasone (KPd)

This trial is designed to estimate the efficacy of a carfilzomib-based triplet in first or second relapse of multiple myeloma for subjects refractory to lenalidomide. The study is an open-label, phase 2 trial. Subjects may receive treatment until progression.

Myeloma disease status will be monitored locally for response and progression per International Myeloma Working Group (IMWG) criteria (Kumar et al, 2016) every 28 ± 7 days from cycle 1 day 1 until confirmed progressive disease (PD), death, lost to follow-up, or withdrawal of full consent (whichever occurs first), regardless of cycle duration, dose delays or treatment discontinuation. Subjects with a suspected complete response (CR) or better will have a bone marrow for minimal residual disease (MRD) assessment at 12 and 24 months (± 4 weeks) from start of treatment (unless a MRD assessment was performed within 4 months before planned assessment).

Subjects who end study drug(s) without confirmed PD are required to complete disease response assessments and report new anti-myeloma treatment every 28 ± 7 days until first subsequent anti-myeloma treatment, death, lost to follow-up, withdrawal of full consent, confirmed PD, or end of study, whichever occurs first. Subjects who discontinue treatment and either start new anti-myeloma treatment or have PD will enter long-term follow-up every 12 weeks until death or end of study.

Approximately one-third of subjects enrolled in the study will be in first relapse and two-thirds in second relapse.

This study will enroll adults ≥ 18 years of age with first or second relapse multiple myeloma.

Eligible subjects will have relapsed multiple myeloma after receiving 1 or 2 prior lines of therapy.

Subjects must be refractory to lenalidomide. Subjects may not have received prior pomalidomide. Prior exposure to a proteasome inhibitor is allowed. Subjects previously exposed to carfilzomib must have responded with at least a partial response to carfilzomib, must not have discontinued carfilzomib due to toxicity, may not have relapsed while receiving or within 60 days of the last dose of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval since their last dose of carfilzomib.

Subjects must have measurable disease per IMWG consensus criteria, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2, and at least partial response to 1 line of therapy.

Arms: arm 1: Carfilzomib, pomalidomide, and dexamethasone (KPd)
Interventions: intervention 1: Carfilzomib intervention 2: Dexamethasone intervention 3: Pomalidomide
Intervention descriptions: intervention 1: Carfilzomib will be administered intravenously over 30 ± 5 minutes, on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression. A dose of 20 mg/m\^2 will be administered on day 1 of cycle 1. All subsequent doses will be 56 mg/m\^2. The frequency of carfilzomib administration will be reduced to day 1 and 15 per cycle starting with cycle 13 and continued until progression or end of study. intervention 2: Dexamethasone will be administered at least 30 minutes, but no more than 4 hours prior to carfilzomib on days of carfilzomib administration. Dexamethasone will be administered at a dose of 40 mg on days 1, 8, 15, and 22 of each 28-day cycle up to progression during cycles 1 to 12. Dexamethasone will be administered at a dose of 20 mg on days 1 and 15 of each 28-day cycle up to progression during cycles 13 onward. For subjects more than or equal to 75 years of age, the dose will be 20 mg during cycles 1 through 12 and 10 mg from cycles 13 onward. intervention 3: Pomalidomide dose will be 4 mg per day orally on days 1 to 21 of each cycle until progression.

Protocol documents:
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SAP_001.pdf: 
Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 1 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
Statistical Analysis Plan 
Protocol Title: 
An Open-label, Phase 2 Study Treating Subjects With 
First or Second Relapse of Multiple Myeloma With 
Carfilzomib, Pomalidomide, and Dexamethasone (KPd)  
Short Protocol Title: 
A Study Evaluating Treatment of Multiple Myeloma With 
Carfilzomib in Combination With Pomalidomide and 
Dexamethasone 
Protocol Number: 
20180117 
NCT Number: 
NCT04191616 
Authors: 
, 
Biostatistics Manager, Amgen Inc. 
, 
Biostatistician, PAREXEL International 
Sponsor: 
Amgen Inc. 
One Amgen Center Drive 
Thousand Oaks, CA 91320 USA 
SAP Date: 
Document Version 
Date 
Original (V1.0) 
Amendment 1 (v2.0) 
Amendment 2 (v3.0) 
19 December 2019 
17 March 2021 
7 September 2022 
 


Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 2 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
Version Number 
Date 
(DDMMMYYYY) 
Summary of Changes,  
including rationale for changes 
Original (v1.0) 
19 December 2019 
Original Version 
Amendment 1 (v2.0) 
17 March 2021 
Changes:  
1.Introduction:   
Deleted: 
Protocol date- 17 September 2019 
 
Added:  
Protocol date- 13 May 2020 
 
2.Objectives and endpoints: 
Primary: 
Change MRD negative response with 
MRD negative complete response 
MRD[-]CR. 
 
Change window period  2 weeks with  
4 weeks. 
 
Secondary: 
Move overall response as the first 
endpoint within the secondary endpoints 
 
2.2 Hypotheses and/or Estimation 
Change to: 
The primary hypothesis is that KPd will 
improve MRD[-]CR rate at 12 months 
compared with the reference MRD[-]CR 
rate.  This corresponds to evaluating 
whether the lower bound of the 90 CI 
of MRD[-]CR rate at 12 months excludes 
the reference rate of 3.  The 
secondary hypothesis is that KPd will 
improve ORR compared with the 
reference ORR.  This corresponds to 
evaluating whether the lower bound of 
the 90 CI of ORR excludes the 
reference rate of 60.  The secondary 
hypothesis will be assessed only after 
the primary objective is met. 
3.1 Study Design 
Added: 
treating subjects with first or second 
relapse of multiple myeloma who were 


Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 3 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
refractory to prior lenalidomide treatment 
and may have been exposed to prior 
daratumumab .  Based on available 
information for this study population, the 
reference rate for MRD[-]CR was 
considered to be 3, while for ORR was 
considered to be 60. 
 
Added:  
suspected CR or better  
 
Deleted: at least very good partial 
response. 
 
Change window period  2 weeks with 
 4 weeks 
 
3.2 Sample Size 
Changed to: 
The sample size was determined based 
on  practical consideration and the intent 
to optimize the power for testing the 
primary hypothesis at 1-sided alpha of 
0.05.  With 85 subjects (safety 
population), the power for testing the 
primary hypothesis and secondary 
hypothesis at 1-sided alpha of 0.05 is 
expected to be more than 85.  As 
these estimates are based on data 
available in the study population, 
additional scenarios for the experimental 
arm and power are included in 
Table 3-1. 
 
Updated Table 3-1 
 
4.2: Subgroups 
Added:   
During maintenance yes vs no  
 
 
5: Definitions  
Added: 
MRD[-]CR 
 
suspected CR 
 


Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 4 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
Change window period  2 weeks with 
 4 weeks 
 
Added: “Maintaining MRD[-]CR for at 
least 12 months minus 4 weeks is 
considered as sustained” in the 
Sustained MRD[-] CR Rate. 
Changed 30 days with 30 (3) days in 
the “ Treatment-emergent Adverse 
Event” 
 
6.1.2 MRD Evaluable Analysis Set 
Added: 
At baseline  
 
7.1 Sustained MRD analysis 
 
Changed durable MRD analysis with 
sustained MRD analysis 
 
9. Statistical Methods of Analysis 
 
Changed 80 CI to 90 CI throughout 
 
9.5 Efficacy Analysis  
 
Deleted:  
“The data will include the MRD results 
from bone marrow samples obtained 
from subjects with a response of VGPR 
or better obtained no earlier than 
8 months and no later than 12 months 
plus 2 weeks after enrollment” from the 
table 9-1 
 
Added: 
MRD[-]CR 
Suspected CR 
Change window period  2 weeks with 
 4 weeks 
9.5.1 Analyses of Primary Efficacy 
Endpoint(s) 
Added: 
MRD[-]CR 
Suspected CR 


Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 5 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
Change window period  2 weeks with 
 4 weeks 
 
9.5.2 Analyses of Exploratory Efficacy 
Endpoint(s) 
Added:  
“in the MRD Evaluable Analysis Set” 
“In addition, similar analysis may be 
done for MRD response at 12 months 
and 24 months landmarks, if 
appropriate” in the  
PFS by depth of MRD response at: 10-4, 
10-5, 10-6, 
 
Updated: 
“The Cox proportional hazard model will 
also be fitted with MRD[-] status or 
MRD[-]CR status as the 
time-dependent covariate to explore 
the correlation between MRD status and 
PFS.” 
Amendment 2 (v3.0) 
 
Changes:  
List of Abbreviations 
Added: 
Abbreviations of MM and sCR 
 
1. Introduction   
Deleted: 
Protocol date- 13 May 2020 
 
Added:  
Protocol date- 16 May 2022 
 
2.1 Objectives and 
Endpoints/Estimands 
Updated: 
Primary Endpoint was changed from 
Estimate the rate of minimal residual 
disease negative complete response 
(MRD[-]CR) at 12 months landmark to 
Estimate the overall response rate 
(ORR) per the changes of protocol 
amendment 4 
 
Key Secondary Endpoint was changed 
from Estimate the overall response rate 


Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 6 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
(ORR) to Estimate the rate of minimal 
residual disease negative complete 
response (MRD[-]CR) at 12 months 
landmark per the changes of protocol 
amendment 4 
 
Updated “sustained MRD[-]CR at a 
sensitivity of 10 5 using NGS based 
method in the bone marrow at 24 
months  4 weeks from start of 
treatment and calculated only within the 
subjects who reached MRD[-]CR in the 
time window for key secondary 
endpoint assessment” per the changes 
of protocol amendment 4 
 
Updated “
 levels in peripheral blood at 12 
and 24 months ( 4 weeks)” per the 
protocol 
 
Deleted: 
Removed Estimate ORR at 12 months 
landmark from secondary endpoint from 
Secondary Endpoint per the changes of 
protocol amendment 4 
 
Deleted the typo “response” from 
“Estimate the frequency of sustained 
MRD[-]CR” 
 
Deleted the typo “Percentage of” from 
“MRD[-] below the threshold of 10-4, 10-5, 
and 10-6 by NGS-based method at time 
of suspected CR or better” 
 
Removed Evaluate the correlation of 
PFS in high versus standard risk subject 
populations from Exploratory Endpoint 
per the decision of study team 
 
2.2 Hypotheses and/or Estimations 
Updated: 
“The primary hypothesis is that KPd will 
improve ORR by evaluating whether the 
lower bound of the 90 CI of ORR 
excludes the reference rate of 60.  The 
secondary hypothesis is that KPd will 


Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 7 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
improve MRD[-]CR rate at 12 months 
by evaluating whether the lower bound 
of the 90 CI of MRD[-]CR rate at 12 
months excludes the reference rate of 
3.“ per the changes of protocol 
amendment 4 
 
Added: 
“Both exact binomial 2-sided 90 and 
95 CIs will be generated around the 
point estimate for each of these 
endpoints.” per the changes of protocol 
amendment 4 
 
3.1 Study Design 
Added: 
Added “or other anti-CD38 antibody 
therapy” per the protocol 
 
Updated: 
Updated “the reference rate listed in 
the protocol section 4.2 indicates the 
ORR was considered to be 60, while 
for MRD[-]CR was considered to be 
3.” per the changes of protocol 
amendment 4 
 
3.2 Sample Size 
Updated: 
Updated “The sample size was 
determined based on feasibility and the 
intent to optimize the power for testing 
the primary hypothesis at 1-sided alpha 
of 0.05.” per the protocol 
 
Updated “As these estimates are based 
on recent data available in the study 
population (eg, sub-populations 
within clinical trials CANDOR and 
A.R.R.O.W.)” per the changes of 
protocol amendment 4 
 
Primary Hypothesis and Secondary 
Hypothesis was changed in Table 3-1 
Power for Hypothesized Treatment 
Effect per the changes of protocol 
amendment 4 
 


Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 8 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
Added: 
Added “In late 2021, enrollment was 
discontinued after 54 subjects were 
enrolled due to practical consideration.” 
per the changes of protocol amendment 
4 
 
Added “including those based on the 
actual number of subjects who received 
at least one dose of carfilzomib (52 
subjects)” per the changes of protocol 
amendment 4 
 
Sample size 52 for Primary Hypothesis 
and Secondary Hypothesis was added 
in Table 3-1 Power for Hypothesized 
Treatment Effect per the changes of 
protocol amendment 4 
 
4.2 Subgroups 
Added: 
Added “ORR and PFS will be examined 
for the below subgroup analysis.” for the 
clarification 
 
Added “When there is not a sufficient 
number of subjects in the subgroup, i.e., 
less than 10 of the whole population, 
the subgroup analysis will not be 
conducted” for the clarification 
 
Additional subgroups added for ORR per 
the decision of study team 
 
Cytogenetic risk measured by FISH 
(high risk (t(4;14), t(14;16), deletion 
17p), standard risk) 
 
R-ISS (stage I, stage II, stage III) 
 
Prior anti-CD38 exposure (yes, no) 
 
Refractory to prior anti-CD38 
treatment (yes, no) 
 
Prior bortezomib exposure (yes, no) 
 
Refractory to prior bortezomib 
treatment (yes, no) 
 
Added subgroup analysis for PFS per 
the decision of study team 
 
prior carfilzomib exposure (yes, no)  


Product:  Carfilzomib 
Protocol Number:  20180117 
Date:  7 September 2022 
Page 9 of 65 
CONFIDENTIAL  
 
 
Confidential Clinical Trials 
 
number of prior lines of therapy (1, 
2) 
 
timing of lenalidomide refractoriness 
(during maintenance: yes, no) 
 
Cytogenetic risk measured by FISH 
(high risk (t(4;14), t(14;16), deletion 
17p), standard risk) 
 
R-ISS (stage I, stage II, stage III) 
 
Prior anti-CD38 exposure (yes, no) 
 
Refractory to prior anti-CD38 
treatment (yes, no) 
 
Prior bortezomib exposure (yes, no) 
 
Refractory to prior bortezomib 
treatment (yes, no) 
 
Deleted: 
Deleted “Other endpoints may also be 
examined for these subgroups If 
appropriate.” per the decision of study 
team 
 
 
5. Definition 
Baseline 
Added:  
Added “of any study treatment” for 
clarification 
 
Cytogenetic Risk group as determined 
by Fluorescent in Situ Hybridization 
(FISH) 
Added definition for clarification 
 
Duration of response 
Updated: 
Updated “DOR is defined as the time 
from first evidence of PR or better per 
IMWG-URC to the earliest of disease 
progression or death due to any cause 
for subjects with a best response of PR 
or better. DOR will be censored as per 
the primary PFS endpoint.” per the DES 
IMWG version 8 


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End of Study 
Added: 
Added “for evaluation in the study (ie, 
last subject last visit), including any 
additional parts in the study (eg, long-
term follow-up, additional antibody 
testing), as applicable.” per the protocol 
 
International Staging System (ISS) 
Stage at Baseline 
Added definition for clarification 
 
Last known to be alive date 
Updated for clarification: 
 Date First Taken, Date Last Taken on 
Concomitant Medications, and Other 
Protocol Required Therapy CRFs 
 Date Performed on ECOG 
Performance Status, Vital Signs, 
Echocardiogram, Electrocardiogram, 
Transfusions, Surgery, Procedure, Bone 
Marrow Biopsy - Multiple Myeloma, 
Bone Marrow Aspirate - Multiple 
Myeloma, MRI, PET-CT, CT and X-ray 
CRFs 
 Date Collected on Male Reproductive 
Status, Reproductive Status and 
Pregnancy Test (Local Lab), Chemistry 
(Local Lab), Hematology (Local Lab), 
Coagulation (Local Lab), Immunology 
(Local Lab) CRFs  
 Start Date, Stop Date on 
Investigational Product Administration 
(Carfilzomib), Non-Investigational 
Product Administration 
(Dexamethasone), Investigational 
Product Administration (Pomalidomide), 
and Non-Investigational Product 
Administration (Pomalidomide) CRFs 
 Start date, Stop date on Anti-Myeloma 
/ Anti-Cancer Therapies CRF 
 Assessment Date for MRD sample 
 Date Collected on Pathology FISH 
CRF 
 Date of Assessment on Myeloma 
Response CRF  


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 Date of Last Menstrual Period and 
Breastfeeding Start in Reproductive 
Status and Pregnancy Test (Local Lab) 
CRF 
 COVID-19 Start Date in Confirmed 
COVID-19 Status CRF 
 Date Decision Was Made to End 
Investigational Product on End of 
Investigational Product Administration 
(Carfilzomib), Date Decision Was Made 
to End Non-Investigational Product on 
End of Non-Investigational Product 
Administration (Dexamethasone), 
Investigational Product Administration 
(Pomalidomide), and End of Non-
Investigational Product Administration 
(Pomalidomide) CRFs, where the 
Primary Reason for ending treatment is 
not Death or Lost to follow-up 
 
MRD[-]CR Rate at 12 Months Landmark 
Updated: 
Updated “no later than 12 months plus 4 
weeks after the start of study 
treatment.” per the protocol 
 
Added: 
Added “The sensitivity analysis of MRD[-
]CR Rate at 12 months landmark will be 
based on MRD Evaluable Analysis Set.” 
for clarification 
 
MRD[-]CR Rate at Any Time During 
Therapy 
Added: 
Added “The sensitivity analysis of MRD[-
]CR Rate at any time during therapy will 
be based on MRD Evaluable Analysis 
Set.” for clarification 
 
Overall Survival (OS) 
Added “OS  (Death date or date of 
censoring if censored – start of any 
study treatment date  1) / 30.4” for 
clarification 
 
Progression Free Survival (PFS) 


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Changed to: 
Updated “PFS is defined as the time 
from the first dose date of any study 
treatment until the first documentation of 
disease progression or death due to any 
cause, whichever occurs first in the 
absence of subsequent anticancer 
therapy and if not  70  days from the 
last non-NE, post-baseline disease 
assessment. PFS will be censored at the 
last non-NE, post-baseline disease 
assessment or the earlier of the 
following, where applicable: (a) the last 
non-NE, post-baseline disease 
assessment prior to subsequent 
anticancer therapy, or (b) the last non-
NE, post-baseline assessment followed 
 70 days later by disease progression 
or death; otherwise, at first dose date. 
Disease progression is based on the 
IMWG-URC [2016].” per the DES IMWG 
version 8 
 
Relative Dose Intensity 
Updated 
Updated “Day 15” to “Day 28” for 
clarification 
 
Sustained MRD[-]CR Rate at 24 months 
Updated: 
Updated “after achieving MRD[-]CR 
status in the time window of Key 
Secondary endpoint assessment.” per 
the changes of protocol amendment 4 
 
Revised International Staging System 
(R-ISS) Stage at Baseline 
Added definition for clarification 
 
Time to Response 
Added “Time to Response  (response 
start date – start of any study treatment 
date  1) / 30.4” for clarification 
 
Treatment-emergent Adverse Event 
Deleted: 
Removed “investigational product as 
determined by “Did event start before 


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first dose of investigational product” 
equal to “No” or missing on the Events 
eCRF” 
“(3)” 
“investigational product” 
per the decision of study team 
 
Changed to: 
Updated “Treatment-emergent adverse 
event: Events categorized as Adverse 
Events (AEs) starting on or after first 
dose of any study treatment and up to 
and including 30 days after the last dose 
of any study treatment excluding events 
reported after End of Study date.” per 
the decision of study team 
 
Primary completion date 
Deleted definition per the decision of 
study team 
 
6.4 Modified Safety Analysis Set 
Added: 
A subset of Safety Analysis Set 
excluding subjects who are impacted by 
COVID-19 was added per the decision 
of study team 
 
6.5 Per Protocol Set(s) 
Deleted: 
Deleted “105 Completed 2 Full Cycles of 
Daratumumab” from major inclusion 
criteria per the protocol 
 
7.1 Primary Analysis 
Updated: 
Updated “The primary analysis will be 
triggered 12 months after the last 
subject enrollment” per the changes of 
protocol amendment 4 
 
7.2 Sustained MRD Analysis 
Added: 
Added “durable” per the protocol 
 


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7.3 Data Review Team Early Stopping 
Guidelines 
Changed title from Interim Analysis and 
Early Stopping Guidelines to Data Review 
Team Early Stopping Guidelines for 
clarification 
 
8.3 Handling of Missing and 
Incomplete Data 
Added: 
Added “No imputation for missing data 
of outcomes will be performed” for 
clarification 
 
Added “The handling of Incomplete 
dates for the start and stop of adverse 
event, concomitant medications, new 
antimyeloma therapy, death, prior 
multiple myeloma therapy, and 
relapse/progression to prior multiple 
myeloma therapy are described in 
Appendix A” per the decision of study 
team 
 
Updated: 
Updated “Sensitivity analyses might be 
needed to evaluate the robustness of 
the primary analysis.” per the protocol 
 
Added: 
Added “stop” of adverse event  
described in “Appendix A” 
for clarification 
 
9.1 General Considerations 
Added: 
Added “The evaluation of whether the 
key secondary objective was met will 
follow a fixed-sequence approach using 
the 90 exact confidence interval:  the 
key secondary objective is met only after 
the primary objective is met.” per the 
changes of protocol amendment 4 
 
9.2 Subject Accountability 
Added: 


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 Number () of subjects who 
discontinued each study treatment 
(carfilzomib, dexamethasone, 
pomalidomide) due to COVID-19 control 
measures” was added the GDE-409220 
 Number of subjects enrolled but not 
dosed was added for clarification 
 
Updated: 
 Number of subjects screened but not 
enrolled (screen failures) was updated 
to correct the typo 
 
9.3 Important Protocol Deviations 
Added: 
Added Summary of IPD listing including 
COVID-19 related IPD per the the GDE-
409220 
 
9.4 Demographic and Baseline 
Characteristics 
Updated per the decision of study team: 
- Race  (If multiple races have been 
reported for a subject, the subject will 
be categorized as multiple race) 
- Region (Europe, Non-Europe) 
- Age (years) (as continuous variable; as 
categorical variable: 18 to  65, 65 to  
75, 75 to  85,  85 years; 65, 65; 
18-65, 65-75, 75)   
- Cardiopulmonary history (yes, no) by 
diagnosis category, no) 
- Prior lenalidomide treatment (yes, no) 
- Refractory to prior lenalidomide 
treatment (yes, no) 
- Prior PI treatment (yes, no) 
- Prior anti-CD38 exposure (yes, no) 
- Refractory to prior anti-CD38 treatment 
(yes, no) 
- Prior bortezomib treatment (yes, no) 
- Refractory to prior bortezomib 
treatment (yes, no) 
- Cytogenetic risk measured by FISH 
(high risk (t(4;14), t(14;16) ,deletion 
17p), standard risk, missing) 
- Prior tobacco use (yes, no) 


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- Albumin (g/dL) (as continuous 
variables; as categorical variable: 3.5, 
3.5) 
- Time since last relapse (months) 
 
9.5 Efficacy Analyses 
Updated: 
Updated “The primary analyses will be 
based on the safety analysis set, while 
sensitivity analyses will use different 
population analysis set listed in table 
9-1.” for the clarification 
 
Updated Overall Response Rate (ORR) 
in Table 9 1. Primary Efficacy Endpoint 
Summary Table per the changes of 
protocol amendment 4 
 
Updated MRD[-]CR at a sensitivity of 10-
5 using next generation sequencing 
(NGS)-based method in the bone 
marrow at 12 months  4 weeks from 
start of treatment in Table 9 2. 
Secondary Efficacy Endpoint Summary 
Table per the changes of protocol 
amendment 4 
 
Updated Sensitivity analyses for OS in 
Table 9 2. Secondary Efficacy Endpoint 
Summary Table for clarification 
 
Deleted: 
Deleted Overall Response Rate at 12 
months landmark in Table 9 2. 
Secondary Efficacy Endpoint Summary 
Table per the changes of protocol 
amendment 4 
 
9.5.1 Analyses of Primary Efficacy 
Endpoint(s)/Estimand(s) 
Added: 
Overall Response Rate (ORR) 
Added “The lower bound of the 90 
exact binomial CI is evaluated whether it 
is larger than the reference ORR.  If that 
happens, then the primary objective is 


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met.” per the changes of protocol 
amendment 4 
 
9.5.2 Analyses of Secondary Efficacy 
Endpoint(s) 
MRD[-] CR at sensitivity of 10-5 using 
NGS-based method in the bone marrow 
at 12 months  4 weeks from start of 
treatment. 
Added: 
Added “If the primary objective is met, 
then the lower bound of the 90 exact 
binomial CI is greater than the reference 
MRD[-]CR rate. If that happens, the key 
secondary objective is met.” per the 
changes of protocol amendment 4 
 
MRD[-] response at a sensitivity of 10-5 
using NGS based method in the bone 
marrow at any time during therapy 
Added:  
Added “It will be analyzed using the 
same method as described for the key 
secondary endpoint.” per the changes 
of protocol amendment 4 
 
Deleted: 
Deleted Overall Response Rate (ORR) 
by 12 months per the changes of 
protocol amendment 4 
 
Added: 
PFS 
Added “The subcategory of death with 
the primary reason of COVID-19 
infection or COVID-19 pneumonia will be 
included in the PFS events.” per the 
decision of study team 
 
9.5.3 Analyses of Exploratory Efficacy 
Endpoint(s) 
Added: 
Added “When there is not a sufficient 
number of subjects in the subgroup, i.e., 
less than 10 of the MRD population, 
the analysis will not be conducted.” for 
clarification 


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Deleted: 
Deleted The correlation PFS in high vs 
standard risk subject’s population per 
the decision of study team 
 
9.6 Safety Analyses 
Added: 
Added 9.6.9 Exposure to Non-
investigational Product for clarification  
 
9.6.2 Adverse Events 
Deleted: 
Removed “All AEs, including TEAEs, will 
be included in individual subject listings. 
All on study deaths will be listed.” per 
the decision of study team 
 
 
9.6.3 Laboratory Test Results 
Deleted for clarification: 
Nucleated RBC  
Deleted “(+3)” from  30 days 
 
Removed “All available laboratory 
results will be included in the subject 
data listings.” per the decision of study 
team 
 
9.6.8 Exposure to Investigational 
Product 
Added: 
Added “Descriptive statistics will be 
produced to describe the exposure to 
investigational product.” for clarification  
Added “If the reason for dose 
modification is COVID-19 control 
measures which is recorded in the 
specified filed (Other) on the CRF, then 
the number () with COVID-19 control 
measures will also be presented. The 
summary will include the following:” per 
the GDE-409220 
 
Updated: 


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Changed study treatments to 
investigational product for clarification 
 
Added a new section for clarification 
9.6.9 Exposure to Non-investigational 
Product 
 
9.7 Other Analyses 
Deleted: 
Deleted “and RVEF” per the decision of 
study team 
 
10. Changes From Protocol-specified 
Analyses 
Added: 
Deviations in superseding protocol 
amendment 3 
Analyses for COVID-19 impact 
Additional subgroup analysis 
Additional subgroups 
 
Appendices: 
Added: 
Appendix A. Handling of Dates, 
Incomplete Dates and Missing Dates 
 


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Table of Contents 
Table of Contents ................................................................................................. 20 
1. 
Introduction ........................................................................................................... 24 
2. 
Objectives, Endpoints and Hypotheses ................................................................. 24 
2.1 
Objectives and Endpoints/Estimands ........................................................ 24 
2.2 
Hypotheses and/or Estimations ................................................................. 26 
3. 
Study Overview .................................................................................................... 26 
3.1 
Study Design ............................................................................................. 26 
3.2 
Sample Size .............................................................................................. 27 
3.3 
Adaptive Design ........................................................................................ 28 
4. 
Covariates and Subgroups ................................................................................... 28 
4.1 
Planned Covariates ................................................................................... 28 
4.2 
Subgroups ................................................................................................. 28 
5. 
Definitions ............................................................................................................. 28 
6. 
Analysis Sets ........................................................................................................ 38 
6.1 
Full Analysis Set........................................................................................ 38 
6.1.1 
Primary Analysis Set ................................................................. 38 
6.2 
Safety Analysis Set ................................................................................... 39 
6.3 
MRD Evaluable Analysis Set ..................................................................... 39 
6.4 
Modified Safety Analysis Set ..................................................................... 39 
6.5 
Per Protocol Set(s) .................................................................................... 40 
6.6 
Health-related Quality-of-Life or Health Economics Analyses 
Set(s) ........................................................................................................ 41 
6.7 
Pharmacokinetic/Pharmacodynamic Analyses Set(s) ................................ 41 
6.8 
Interim Analyses Set(s) ............................................................................. 41 
6.9 
Study-specific Analysis Sets...................................................................... 41 
7. 
Planned Analyses ................................................................................................. 41 
7.1 
Primary Analysis ....................................................................................... 41 
7.2 
Sustained MRD Analysis ........................................................................... 41 
7.3 
Data Review Team Early Stopping Guidelines .......................................... 42 
7.4 
Final Analysis ............................................................................................ 42 
8. 
Data Screening and Acceptance ........................................................................... 42 
8.1 
General Principles ..................................................................................... 42 
8.2 
Data Handling and Electronic Transfer of Data ......................................... 42 
8.3 
Handling of Missing and Incomplete Data ................................................. 42 
8.4 
Detection of Bias ....................................................................................... 42 
8.5 
Outliers ..................................................................................................... 42 
8.6 
Distributional Characteristics ..................................................................... 42 
8.7 
Validation of Statistical Analyses ............................................................... 43 


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9. 
Statistical Methods of Analysis.............................................................................. 43 
9.1 
General Considerations ............................................................................. 43 
9.2 
Subject Accountability ............................................................................... 43 
9.3 
Important Protocol Deviations ................................................................... 44 
9.4 
Demographic and Baseline Characteristics ............................................... 45 
9.5 
Efficacy Analyses ...................................................................................... 46 
9.5.1 
Analyses of Primary Efficacy Endpoint(s)/Estimand(s) .............. 51 
9.5.2 
Analyses of Secondary Efficacy Endpoint(s).............................. 51 
9.5.3 
Analyses of Exploratory Efficacy Endpoint(s) ............................. 52 
9.6 
Safety Analyses ........................................................................................ 53 
9.6.1 
Analyses of Primary Safety Endpoint(s) ..................................... 53 
9.6.2 
Adverse Events ......................................................................... 53 
9.6.3 
Laboratory Test Results ............................................................ 54 
9.6.4 
Vital Signs ................................................................................. 55 
9.6.5 
Physical Measurements ............................................................ 56 
9.6.6 
Electrocardiogram ..................................................................... 56 
9.6.7 
Antibody Formation ................................................................... 56 
9.6.8 
Exposure to Investigational Product .......................................... 56 
9.6.9 
Exposure to Non-investigational Product ................................... 57 
9.6.10 
Exposure to Other Protocol-required Therapy ........................... 57 
9.6.11 
Exposure to Concomitant Medication ........................................ 57 
9.7 
Other Analyses ......................................................................................... 57 
9.7.1 
Analyses of Pharmacokinetic or 
Pharmacokinetic/Pharmacodynamic Endpoints ......................... 58 
9.7.2 
Analyses of Clinical Outcome Assessments .............................. 58 
9.7.3 
Analyses of Health Economic Endpoints ................................... 58 
9.7.4 
Analyses of Biomarker Endpoints .............................................. 58 
10. 
Changes From Protocol-specified Analyses.......................................................... 58 
11. 
Literature Citations / References ........................................................................... 60 
12. 
Prioritization of Analyses....................................................................................... 61 
13. 
Appendices ........................................................................................................... 63 
Appendix A.  Handling of Dates, Incomplete Dates and Missing Dates ................. 64 
 
List of Table 
Table 3-1.  Power for Hypothesized Treatment Effect .................................................... 27 
Table 5-1.  Conventions for Censoring for PFS ............................................................. 33 
Table 9-1.  Primary Efficacy Endpoint Summary Table .................................................. 46 
Table 9-2.  Secondary Efficacy Endpoint Summary Table ............................................. 47 
 


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List of Abbreviations 
 
AE 
adverse event 
ALT 
alanine aminotransferase 
ALP 
alkaline phosphatase 
AUC 
area under the concentration-time curve 
BSA 
body surface area 
BUN 
blood urea nitrogen 
CBC 
complete blood count 
Cmax 
maximum observed concentration 
COA 
clinical outcomes assessment 
CR 
complete response 
CRF 
case report form 
CRO 
contract research organization 
CTCAE 
Common Terminology Criteria for Adverse Events 
CT 
computed tomography 
D 
Dexamethasone 
Dara-IV 
daratumumab IV 
Dara-SC 
daratumumab for subcutaneous administration 
Dex 
Dexamethasone 
DLCO 
diffusing capacity of the lungs for carbon monoxide 
DRT 
data review team 
ECG 
Electrocardiogram 
Echo 
Echocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
ECOG PS 
Eastern Cooperative Oncology Group Performance Status 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
FEV 
forced expiratory volume 
FISH 
fluorescence in situ hybridization 
HbA1c 
hemoglobin A1c 
HDL 
lactate dehydrogenase 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
IFE 
Immunofixation 
Ig, IgA, IgD, IgE, IgM 
immunoglobulin, immunoglobulin A, immunoglobulin D, 
immunoglobulin E, immunoglobulin M 


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IMiD 
immunomodulatory drug 
IMWG 
International Myeloma Working Group 
IMWG-URC 
International Myeloma Working Group Uniform Response 
Criteria 
IV 
Intravenous 
K 
Carfilzomib 
KPd 
carfilzomib in combination with pomalidomide and 
dexamethasone 
LDH 
lactate dehydrogenase 
LDL 
low density lipoprotein 
LTFU 
long-term follow-up 
mAb 
monoclonal antibody 
MCH 
mean corpuscular hemoglobin 
MCHC 
mean corpuscular hemoglobin concentration 
MCV 
mean corpuscular volume 
MM 
multiple myeloma 
MRD 
minimal residual disease 
MRD[-] 
minimal residual disease negative 
NCI 
National Cancer Institute 
NCI-CTCAE 
National Cancer Institute-Common Terminology Criteria for 
Adverse Events 
NDMM 
newly diagnosed multiple myeloma 
NGS 
next-generation sequencing 
ORR 
overall response rate 
OS 
overall survival 
ORCA 
Onyx Response Computer Algorithm 
Pd 
pomalidomide and dexamethasone 
PD 
progressive disease 
PDn 
pharmacodynamics 
PET/CT 
positron emission tomography/computed tomography 
PFS 
progression-free survival 
PFT 
pulmonary function tests 
PI 
proteasome inhibitor 
N/A 
Not Applicable 
sCR 
stringent complete response 
 


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1. 
Introduction 
The purpose of this Statistical Analysis Plan (SAP) is to provide details of the statistical 
analyses that have been outlined within the protocol for study 20180117, Carfilzomib 
dated 16 May 2022.  The scope of this plan includes the primary analysis and the final 
analysis that is planned and will be executed by the Amgen Global Biostatistical Science 
department unless otherwise specified. 
2. 
Objectives, Endpoints and Hypotheses 
2.1 
Objectives and Endpoints/Estimands 
 
Objectives 
Endpoints 
Primary 
 
Estimate the overall response rate 
(ORR) 
 
overall response defined as the best 
overall confirmed response of partial 
response (PR), very good partial 
response (VGPR), complete 
response(CR), or stringent complete 
response(sCR) by Independent Review 
Committee (IRC) per International 
Myeloma Working Group Uniform 
Response Criteria (IMWG-URC) 
Key Secondary 
 
Estimate the rate of minimal residual 
disease negative complete response 
(MRD[-]CR) at 12 months landmark 
 
MRD[-]CR at a sensitivity of 10-5 using 
next generation sequencing(NGS)-
based method in the bone marrow at 
12 months ± 4 weeks from start of 
treatment 
Secondary 
 
Describe the safety and tolerability of 
carfilzomib combined with 
dexamethasone and pomalidomide 
 
subject incidence of treatment-emergent 
adverse events 
 
Estimate the frequency of best MRD[-] 
response in KPd  
 
MRD[-] response at a sensitivity of 
10-5 using NGS-based method in the bone 
marrow at any time during therapy 
 
Estimate the frequency of sustained 
MRD[-]CR  
 
sustained MRD[-]CR at a sensitivity of 
10-5 using NGS-based method in the bone 
marrow defined as subjects that maintain 
MRD[-]CR 12 months or more after 
achieving MRD[-]CR status, disregarding 
when the first MRD[-]CR was reached 
 
Estimate the frequency of sustained 
MRD[-]CR at landmark 24 months  
 
sustained MRD[-]CR at a sensitivity of 
10-5 using NGS-based method in the 
bone marrow at 24 months ± 4 weeks 
from start of treatment and calculated only 
within the subjects who reached MRD[-
]CR in the time window for key 
secondary endpoint assessment 


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 
Estimate duration of response, time to 
response, progression-free survival 
(PFS), and overall survival (OS) 
 
duration of response, defined as time 
from first date of PR or better to date of 
disease progression or death due to any 
cause 
 
time to response, defined as time from 
start of treatment to first date of PR or 
better 
 
PFS defined as time from start of 
treatment until progression or death from 
any cause 
 
OS, defined as time from start of 
treatment until death from any cause 
 
Estimate rate of CR or better  
 
best overall confirmed response of CR or 
better 
 
 
 


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Objectives 
Endpoints 
Exploratory 
 
Assess the depth of MRD 
 
 MRD[-] below the threshold of 10-4, 10-5, 
and 10-6 by NGS-based method at time of 
suspected CR or better 
 
Evaluate the correlation between MRD 
status and PFS 
 
PFS by depth of MRD response at:  10-4, 
10-5, and 10-6 
 
Evaluate pharmacokinetics (PK) and 
pharmacodynamics (PDn) of carfilzomib 
when administered in combination with 
pomalidomide and dexamethasone 
 
carfilzomib PK parameters (maximum 
observed concentration [Cmax], area under 
the concentration-time curve [AUC], 
half-life [t1/2])  
 
carfilzomib PDn parameters (inhibition of 
proteasome activity relative to baseline) 
 
Assess pharmacogenetics in subjects 
receiving KPd 
 
CD138 selection of tumor cells at 
screening and disease progression 
 
Analyze exploratory biomarkers  
 
 levels in 
peripheral blood at 12 and 24 months 
(± 4 weeks)  
 
2.2 
Hypotheses and/or Estimations 
The primary hypothesis is that KPd will improve ORR by evaluating whether the lower 
bound of the 90% CI of ORR excludes the reference rate of 60%.  The secondary 
hypothesis is that KPd will improve MRD[-]CR rate at 12 months by evaluating whether 
the lower bound of the 90% CI of MRD[-]CR rate at 12 months excludes the reference 
rate of 3%.  The secondary hypothesis will be assessed only after the primary objective 
is met. Both exact binomial 2-sided 90% and 95% CIs will be generated around the 
point estimate for each of these endpoints. 
3. 
Study Overview 
3.1 
Study Design 
The study is an open-label, phase 2 trial treating subjects with first or second relapse of 
multiple myeloma who were refractory to prior lenalidomide treatment and may have 
been exposed to prior daratumumab or other anti-CD38 antibody therapy.  Based on 
available information for this study population, the reference rate listed in the protocol 
section 4.2 indicates the ORR was considered to be 60%, while for MRD[-]CR was 
considered to be 3%.  
Subjects may receive treatment until progression. Myeloma disease status will be 
monitored locally for response and progression per International Myeloma Working 
Group (IMWG) criteria (Kumar et al, 2016) every 28  7 days from cycle 1 day 1 until 


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confirmed progressive disease (PD), death, lost to follow-up, or withdrawal of full 
consent (whichever occurs first), regardless of cycle duration, dose delays or treatment 
discontinuation.   
Subjects with a suspected CR or better will have a bone marrow for minimal residual 
disease (MRD) assessment at 12 and 24 months ( 4 weeks) from start of treatment 
(unless an MRD assessment was performed within 4 months before planned 
assessment).   
Subjects who end study drug(s) without confirmed PD are required to complete disease 
response assessments and report new antimyeloma treatment every 28  7 days until 
first subsequent antimyeloma treatment, death, lost to follow-up, withdrawal of full 
consent, confirmed PD, or end of study, whichever occurs first.  Subjects, who 
discontinue treatment and either start new antimyeloma treatment or have PD, will enter 
long-term follow-up every 12 weeks until death or end of study. 
3.2 
Sample Size 
The sample size was determined based on feasibility and the intent to optimize the 
power for testing the primary hypothesis at 1-sided alpha of 0.05.  With 85 subjects 
(safety population), the power for testing the primary hypothesis and secondary 
hypothesis at 1-sided alpha of 0.05 was expected to be more than 85%.  In late 2021, 
enrollment was discontinued after 54 subjects were enrolled due to practical 
consideration. As these estimates are based on recent data available for the study 
population (eg, sub-populations within clinical trials CANDOR and A.R.R.O.W.), 
additional scenarios, including those based on the actual number of subjects who 
received at least one dose of carfilzomib (52 subjects), for the experimental arm and 
power are included in Table 3-1. 
Table 3-1.  Power for Hypothesized Treatment Effect 
Hypothesis 
Sample Size 
H0 
H1 
Power 
Primary 
85 
ORR ≤ 60% 
ORR ≥ 75% 
90.4% 
85 
ORR ≤ 60% 
ORR ≥ 80% 
99.3% 
52 
ORR ≤ 60% 
ORR ≥ 75% 
69.2% 
52 
ORR ≤ 60% 
ORR ≥ 80% 
91.8% 
Secondary 
85 
MRD[-]CR rate 
at 12 months ≤ 
3% 
MRD[-]CR rate 
at 12 months ≥ 
10% 
86.4% 


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85 
MRD[-]CR rate 
at 12 months ≤ 
3% 
MRD[-]CR rate 
at 12 months ≥ 
12% 
95.1% 
52 
MRD[-]CR rate 
at 12 months ≤ 
3% 
MRD[-]CR rate 
at 12 months ≥ 
10% 
60.5% 
52 
MRD[-]CR rate 
at 12 months ≤ 
3% 
MRD[-]CR rate 
at 12 months ≥ 
12% 
76.3% 
ORR = overall response rate; MRD[-]CR = minimal residual disease negative complete response 
3.3 
Adaptive Design 
Adaptive design is not applicable for this study. 
4. 
Covariates and Subgroups 
4.1 
Planned Covariates 
The relationship of covariates to efficacy endpoints will be explored if appropriate. 
4.2 
Subgroups 
ORR and PFS will be examined for the below subgroup analysis. When there is 
not a sufficient number of subjects in the subgroup, i.e., less than 10% of the 
whole population, the subgroup analysis will not be conducted: 
 
prior carfilzomib exposure (yes, no)  
 
number of prior lines of therapy (1, 2) 
 
timing of lenalidomide refractoriness (during maintenance: yes, no) 
 
Cytogenetic risk measured by FISH (high risk (t(4;14), t(14;16), deletion 17p), 
standard risk) 
 
R-ISS (stage I, stage II, stage III) 
 
Prior anti-CD38 exposure (yes, no) 
 
Refractory to prior anti-CD38 treatment (yes, no) 
 
Prior bortezomib exposure (yes, no) 
 
Refractory to prior bortezomib treatment (yes, no) 
  
5. 
Definitions 
Baseline 
The baseline value is defined as the last assessment prior to the first dose of any study 
treatment. Absolute change from baseline will be defined as (post baseline value - 
baseline value).  Relative change from baseline will be defined as (post baseline value – 
baseline value)/baseline value * 100%.  


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Complete Response Rate (CRR) 
CRR is defined as the proportion of subjects whose best overall response is sCR or CR. 
Cytogenetic Risk group as determined by Fluorescent in Situ Hybridization (FISH) 
The FISH data will be used to determine the cytogenetic risk group as following: 
High risk group: Subjects who have the cytogenetic abnormalities t(4;14) or 
t(14;16), and/or deletion 17p. 
Standard risk group: Subjects who do not have any of the cytogenetic 
abnormalities t(4;14), t(14;16) and deletion 17p. 
Missing: Subjects who cannot be identified as high risk nor standard risk. 
Duration of Response (DOR) 
DOR is defined as the time from first evidence of PR or better per IMWG-URC to the 
earliest of disease progression or death due to any cause for subjects with a best 
response of PR or better. DOR will be censored as per the PFS endpoint. Please see 
Table 5-1 
 DOR = [(PD or death date whichever occurs first) or date of censoring if 
censored - response start date + 1] / 30.4. 
 End of Study 
The end of study date is defined as the date when the last subject across all sites is 
assessed or receives an intervention for evaluation in the study (ie, last subject last 
visit), including any additional parts in the study (eg, long-term follow-up, 
additional antibody testing), as applicable. The study will end 4 years after the last 
subjects is enrolled in the study. 
International Staging System (ISS) Stage at Baseline 
ISS stage at baseline will be calculated using serum beta-2 microglobulin and 
serum albumin values collected at baseline, based on the criteria published by the 
International Myeloma Working Group (Greipp 2005): 
Stage I: Serum beta-2 microglobulin < 3.5 mg/L and serum albumin ≥ 3.5 g/dL 
Stage II: Serum beta-2 microglobulin < 3.5 mg/L and serum albumin < 3.5 g/dL or 
Serum beta-2 microglobulin 3.5–<5.5 mg/L irrespective of the serum albumin 
Stage III: Serum beta-2 microglobulin ≥ 5.5 mg/L 


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Last known to be alive date 
Last known alive date is the latest date of the following dates before death date: 
 
Date First Taken, Date Last Taken on Concomitant Medications, and Other 
Protocol Required Therapy CRFs  
 
Date Performed on ECOG Performance Status, Vital Signs, Echocardiogram, 
Electrocardiogram, Transfusions, Surgery, Procedure, Bone Marrow Biopsy - 
Multiple Myeloma, Bone Marrow Aspirate - Multiple Myeloma, MRI, PET-CT, 
CT and X-ray CRFs  
 
Admission Date, Discharge Date on Hospitalizations, CRF Date of Examination 
on Physical Measurement CRF  
 
Date Collected on Male Reproductive Status, Reproductive Status and 
Pregnancy Test (Local Lab), Chemistry (Local Lab), Hematology (Local Lab), 
Coagulation (Local Lab), Immunology (Local Lab) CRFs  
 
Start Date, Stop Date on Investigational Product Administration (Carfilzomib), 
Non-Investigational Product Administration (Dexamethasone), 
Investigational Product Administration (Pomalidomide), and Non-
Investigational Product Administration (Pomalidomide) CRFs 
 
Date Started and Date Ended or Resulted in Death on Events CRF  
 
Start date, Stop date on Anti-Myeloma / Anti-Cancer Therapies CRF  
 
Subject Status Date if status is Alive on Survival Status CRF  
 
Assessment Date on Skeletal Survey and Plasmacytoma Assessment CRF  
 
Assessment Date for MRD sample 
 
Date Collected on Pathology FISH CRF 
 
Date of Assessment on Myeloma Response CRF  
 
Date of Last Menstrual Period and Breastfeeding Start in Reproductive 
Status and Pregnancy Test (Local Lab) CRF 
 
COVID-19 Start Date in Confirmed COVID-19 Status CRF 
 
Date Decision Was Made to End Investigational Product on End of 
Investigational Product Administration (Carfilzomib), Date Decision Was 
Made to End Non-Investigational Product on End of Non-Investigational, 
Product Administration (Dexamethasone), End of Investigational Product 
Administration (Pomalidomide) and End of Non-Investigational Product 
Administration (Pomalidomide) CRFs, where the Primary Reason for 
ending treatment is not Death or Lost to follow-up 
 
MRD[-]CR 
MRD[-]CR is defined as achievement of CR (including sCR) per IMWG-URC and MRD[-] 
status at a sensitivity of 10-5 using next generation sequencing (NGS) based method in 
the bone marrow at any time. 
MRD[-]CR Rate at 12 Months Landmark 


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MRD[-]CR rate at 12 months landmark is defined as proportion of subjects who reach 
MRD[-]CR at 12 months landmark assessment among all subjects who received at least 
1 dose of carfilzomib.  The sensitivity analysis of MRD[-]CR Rate at 12 months 
landmark will be based on MRD Evaluable Analysis Set. The data will include the 
MRD results from bone marrow samples obtained from subjects with Suspected CR or 
better obtained no earlier than 8 months and no later than 12 months plus 4 weeks after 
the start of any study treatment. 
MRD[-] Rate at Any Time During Therapy 
MRD[-] rate at any time during therapy is defined as proportion of subjects who reach 
MRD[-] at any time during therapy among all subjects who received at least 1 dose of 
carfilzomib.  The sensitivity analysis of MRD[-]CR Rate at any time during therapy 
will be based on MRD Evaluable Analysis Set. The data will include the MRD results 
from bone marrow samples obtained from the subjects with a response of VGPR or 
better at any time during therapy. 
Number of cycles started for any study drug  
It is defined as the total number of treatment cycles in which at least one dose of any 
study drug is administered.  
Number of cycles started for each study drug 
It is defined as the total number of treatment cycles in which at least one dose of 
carfilzomib/pomalidomide/dexamethasone, respectively, is administered. 
Number of cycles started for all study drugs 
It is defined as the total number of treatment cycles in which at least one dose of 
carfilzomib, one dose of pomalidomide and one dose of dexamethasone is administered. 
Number of doses of carfilzomib administered  
It is defined as the total number of non-zero doses of carfilzomib a subject received 
during the treatment period of the study 
Number of doses of pomalidomide administered  
It is defined as the total number of non-zero doses of pomalidomide a subject received 
during the treatment period of the study 
Number of doses of dexamethasone administered  


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It is defined as the total number of non-zero doses of dexamethasone a subject received 
during the treatment period of the study  
Overall Response (OR) 
OR is the best overall confirmed response of partial response (PR), very good partial 
response (VGPR), complete response (CR), or stringent complete response (sCR). 
Overall Response Rate (ORR) 
Overall Response Rate (ORR) is defined as the proportion of subjects that reach the 
overall response among all subjects who received at least 1 dose of the carfilzomib. 
Overall Survival (OS) 
OS is defined as time from start of treatment until death from any cause. 
OS = (Death date or date of censoring if censored – start of any study treatment date + 
1) / 30.4 
Subjects still alive will be censored at the date last known to be alive. If the date last 
known to be alive is after the date that triggers the analysis (ie, the data cutoff date), the 
subject will be censored at the analysis trigger date.  
Progression Free Survival (PFS) 
PFS is defined as the time from the first dose date of any study treatment until the 
first documentation of disease progression or death due to any cause, whichever 
occurs first in the absence of subsequent anticancer therapy and if not > 70  days 
from the last non-NE, post-baseline disease assessment. PFS will be censored at 
the last non-NE, post-baseline disease assessment or the earlier of the following, 
where applicable: (a) the last non-NE, post-baseline disease assessment prior to 
subsequent anticancer therapy, or (b) the last non-NE, post-baseline assessment 
followed > 70 days later by disease progression or death; otherwise, at first dose 
date. Disease progression is based on the IMWG-URC [2016].  
PFS time in months= [(PD or death date, whichever occurs first) or date of censoring if 
censored– start of treatment date + 1] / 30.4. 


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Table 5-1.  Conventions for Censoring for PFS 
Situation 
Date of Progression or 
Censoring  
Outcome  
No PD or death, no new 
anticancer treatment 
Last visit; otherwise, first 
dose date of any study 
treatment 
Censored 
 
No PD or death, new 
anticancer treatment 
Last visit prior to new 
treatment; otherwise, first 
dose date of any study 
treatment 
Censored 
PD or death > 70 days 
after last visit 
Last visit prior to PD or 
death; otherwise, first dose 
date of any study treatmenta 
Censored 
PD or death, no prior new 
anticancer therapy 
Earlier of PD or deathb 
Event 
No PD, new anticancer 
treatment, death 
Last visit prior to new 
treatment; otherwise, first 
dose date of any study 
treatmentb 
Censored 
“Visit” refers to a post-baseline evaluable disease assessment.  
aIf new anticancer therapy starts prior to PD or death, PFS will be censored at the 
earliest of the following: (a) the last evaluable disease assessment prior to 
subsequent anticancer therapy, or (b) the last non-NE, post-baseline assessment 
followed > 70 days later by disease progression or death; otherwise, first dose date." 
bPFS will be censored if PD or death > 70 days after last evaluable disease 
assessment. 
 
Relative Dose Intensity 
RDI reflects whether the dose intensity of a therapy was implemented as planned. It will 
be calculated as the ratio of actual dose intensity relative to planned dose intensity 
Relative Dose Intensity (RDI) = 
Actual dose intensity 
Planned dose intensity 
 
For carfilzomib: Actual dose intensity is defined as the actual amount of drug in mg/m2 
delivered to a subject per week of treatment.  


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Actual Dose Intensity (mg/m2/week) = 
Actual cumulative dose (mg/ m2) 
Number of weeks of actual treatment 
Actual cumulative dose in (mg/m2) is the sum of received doses (mg) divided by baseline 
body surface area (BSA) (m2) of the patient.  Each subject’s first dose of carfilzomib will 
be calculated based upon baseline BSA using the Mosteller formula.  The dose for each 
subject should not be revised unless the subject experiences a change in body weight of 
> 20% in which case the BSA and dose should be recalculated.  The recalculated BSA 
becomes the new baseline and is used in dose calculation.  BSA will be capped at 2.2 
for carfilzomib. Number of weeks of actual treatment will be calculated as (Last Dose 
Date of carfilzomib – First Dose Date of carfilzomib + i ) / 7.  When the last cycle is 
among cycles 1 to 12, i = 7 if the last infusion is given on day 1 or 8 within the last cycle, 
i = 14 if the last infusion is given on day 15.  When the last cycle is among cycles 13+, i 
= 14 if the last infusion is given on day 1 or day 15 within the last cycle. 
Planned dose intensity is defined as the planned amount of carfilzomib in mg/m2 
delivered to a subject per week of treatment.  
Planned Dose Intensity (mg/m2/week) = 
Planned cumulative dose (mg/ m2) 
Number of protocol specified treatment 
weeks 
It will be calculated as the planned cumulative dose of carfilzomib in mg/m2 divided by 
the planned number of weeks for the treatment per protocol based on the corresponding 
cycle and day of the last carfilzomib infusion. Per protocol, one cycle is 28 days 
(4 weeks), so the planned number of treatment weeks will be calculated as 4 x (c-1) + j, 
where c is the cycle in which the last carfilzomib infusion is given.  When c is less than or 
equal to 12, j =1 if the last carfilzomib infusion is given on day 1 within the last cycle, j=2 
if the last infusion is given on day 8 , j=4 if the last infusion is given on day 15.  When c is 
greater than or equal to 13, j=2 if the last infusion is given on day 1 within the last cycle, 
j=4 if the last infusion is given on day 15.  The planned cumulative dose of carfilzomib is 
the summation of planned carfilzomib dose (mg/m2) per week as: [20, 56, 56, 0] in cycle 
1, [56, 56, 56, 0] in cycle 2 to 12 and [56, 0, 56, 0] in cycle 13 onwards, across the 
planned number of treatment weeks. 
For dexamethasone: Actual dose intensity is the actual amount of drug in mg delivered 
to a subject per week of treatment.  


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Actual Dose Intensity (mg/week) = 
Actual cumulative dose (mg) 
Number of weeks of actual treatment 
The cumulative dose in mg is the summation of total quantity administered (mg) over the 
study. Number of weeks of actual treatment will be calculated as (Last Dose Date of 
dexamethasone – First Dose Date of dexamethasone + i)/7.  When the last cycle is 
among cycle 1 to 12, i=7 if the last dexamethasone dose is given on day 1, 8, 15, or 22.  
When the last cycle is among cycle 13+, i = 14 if the last dexamethasone dose is given 
on day 1 or day 15 within the last cycle.  Planned dose intensity (mg/week) is defined as 
the planned amount of dexamethasone in mg delivered to a subject per week of 
treatment.  
Planned Dose Intensity (mg/week) = 
Planned cumulative dose (mg) 
Number of protocol specified treatment 
weeks 
It will be calculated as the planned cumulative dose of dexamethasone in mg divided by 
the planned number of weeks for the treatment per protocol based on the corresponding 
cycle and day of the last dexamethasone dose. Per protocol, one cycle is 28 days 
(4 weeks), so the planned number of treatment weeks will be calculated as 4 x (c-1) + j, 
where c is the cycle in which the last dexamethasone dose is given.  When c is less than 
or equal to 12, j =1 if the last dexamethasone dose is given on day 1 within the last 
cycle, j=2 if the last dose is given on day 8, j=3 if the last dose is given on day 15, j=4 if 
the last dose is given on 22.  When c is greater than or equal to 13, j=2 if the last dose is 
given on day 1, j=4 if the last dose is given on day 15.  The planned cumulative dose of 
dexamethasone is the summation of planned dexamethasone dose (mg) per week as: 
[40, 40, 40, 40] in cycle 1 to12 (20 mg for subjects >75 years of age) and  [20, 0, 20, 0] 
in cycle 13 onwards (10mg for subjects > 75 years age), across the planned number of 
treatment weeks.  
For pomalidomide: Actual dose intensity is the actual amount of drug in mg delivered to 
a subject per week of treatment.  
Actual Dose Intensity (mg/week) = 
Actual cumulative dose (mg) 
Number of weeks of actual treatment 
The cumulative dose in mg is the summation of total quantity administered (mg) over the 
study. Number of weeks of actual treatment will be calculated as (Last Dose Date of 


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pomalidomide – First Dose Date of pomalidomide + i)/7, where the value of i depends on 
the day of the cycle on which the last pomalidomide is taken, which is shown in the table 
below. 


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The last pomalidomide dose day in the cycle 
Value of i 
Day 1 or Day 8 
7 
Day 2 or Day 9 
6 
Day 3 or Day 10 
5 
Day 4 or Day 11 
4 
Day 5 or Day 12 
3 
Day 6 or Day 13 
2 
Day 7 or Day 14 
1 
Day 15 to Day 28 
14 – (Day # - 15) 
Planned dose intensity (mg/week) is defined as the planned amount of pomalidomide in 
mg delivered to a subject per week of treatment.  
Planned Dose Intensity (mg/week) = 
Planned cumulative dose (mg) 
Number of protocol specified treatment 
weeks 
It will be calculated as the planned cumulative dose of pomalidomide in mg divided by 
the planned number of weeks for the treatment per protocol based on the corresponding 
cycle and day of the last pomalidomide infusion. Per protocol, one cycle is 28 days 
(4 weeks), so the planned number of treatment weeks will be calculated as 4 x (c-1) + j, 
where c is the cycle in which the last pomalidomide dose is taken and j =1 if the last 
pomalidomide dose is taken on day 1 to 7 within the last cycle, j=2 if the last dose is 
given on day 8 to 14, j=4 if the last dose is given on day 15 to 21.  The planned 
cumulative dose of pomalidomide is the summation of planned pomalidomide dose (mg) 
per week ([7*4, 7*4, 7*4, 0]) across the planned treatment weeks.   
Revised International Staging System (R-ISS) Stage at Baseline 
R-ISS stage at baseline will be calculated using ISS, risk group by FISH, and LDH, 
based on the criteria published by the International Myeloma Working Group 
(Palumbo, 2015): 
Stage I: ISS stage I and standard risk group by FISH and normal LDH 
Stage II: Not R-ISS stage I or III 
Stage III: ISS stage III and {either high-risk group by FISH or high LDH} 
Sustained MRD[-]CR Rate 


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Sustained MRD[-]CR rate is defined as the proportion of subjects that maintain 
MRD[-]CR for 12 months +/- 4 weeks or more, ie, maintaining MRD[-]CR for at least 12 
months minus 4 weeks is considered as sustained, after achieving MRD[-]CR status 
among the subjects who reach the MRD[-]CR status, disregarding when the first MRD[-
]CR was reached. 
Sustained MRD[-]CR Rate at 24 months 
Sustained MRD[-]CR rate at 24 months is defined as the proportion of subjects that 
maintain MRD[-]CR for 12 months +/- 4 weeks or more, ie, maintaining MRD[-]CR for at 
least 12 months minus 4 weeks is considered as sustained, after achieving MRD[-]CR 
status in the time window of Key Secondary endpoint assessment. 
Time to Response 
Time from start of treatment to first date of confirmed PR or better. 
Time to Response = (response start date – start of any study treatment date + 1) / 30.4 
Time (month) since initial diagnosis 
Time since initial diagnosis is defined as: 
(Date of informed consent signed - date of first diagnosis of MM + 1) / 30.4 
Treatment-emergent Adverse Event 
Treatment-emergent adverse event: Events categorized as Adverse Events (AEs) 
starting on or after first dose of any study treatment and up to and including 30 days 
after the last dose of any study treatments excluding events reported after End of Study 
date.  
Treatment Duration (weeks) for each study drug 
Treatment duration (weeks) for carfilzomib, dexamethasone and pomalidomide defined 
as: (Date of last dose – Date of first dose + 1)/7. 
6. 
Analysis Sets 
6.1 
Full Analysis Set 
Not Applicable 
6.1.1 
Primary Analysis Set 
Not Applicable 


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6.2 
Safety Analysis Set 
The Safety Analysis Set includes all enrolled subjects who received at least 1 dose of 
carfilzomib. The analysis of efficacy and safety analyses will be based on the Safety 
Analysis Set. 
6.3 
MRD Evaluable Analysis Set 
The MRD Evaluable Analysis Set includes all enrolled subjects with measurable MRD 
status at baseline and at least 1 measurable MRD status postbaseline (subjects who 
don’t have measurable MRD status due to technical issues will be excluded), who 
received at least 1 dose of carfilzomib. The MRD sensitivity analysis will be based on 
MRD Evaluable Analysis Set. 
 
6.4 
Modified Safety Analysis Set 
The modified safety analysis set (mSAS) will be used in the sensitivity analysis for 
primary endpoint and key secondary endpoints, and other efficacy endpoints 
including PFS, OS, and CR in order to adjust for the COVID-19 impact on the 
Safety Analysis Set population. The mSAS is a subset of Safety Analysis Set 
excluding subjects who are impacted by COVID-19.  
The COVID-19 impact refers to:  
(1) any COVID-19 adverse events which are identified using the COVID-19 
Standardized MedDRA Query (SMQ) narrow search strategy, and COVID-19 events 
collected on the Confirmed COVID-19 Status CRF;  
(2) the reason for Investigational Product (IP)/Non-IP Dose Change/Withheld/Dose 
Delay is COVID-19 control measures recorded on the CRFs for IP Administration 
and Non-IP Administration;  
(3) the reason for ending IP/Non-IP is COVID-19 control measures recorded on 
CRFs for End of IP Administration and End of Non-IP Administration;  
(4) important protocol deviations (IPDs) related to COVID-19 control measures;  
(5) COVID-19 related protocol deviation: 940 series, 950 series and 960 series of 
protocol deviation codes in the study IPD list. 
 


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6.5 
Per Protocol Set(s) 
The per protocol analysis set is a subset of the safety analysis set which includes 
subjects who do not have important protocol deviations that might affect the 
interpretation of the analyses of the efficacy endpoints.  Subjects with the following 
protocol deviations will be excluded from the per protocol set: 
Major inclusion criteria not met: 
 
103 – First or Second Relapse 
 
104 – Refractory to Lenalidomide 
 
106 – Measurable Disease 
 
107 – Prior Therapy Response 
 
108 – Prior Carfilzomib Response 
 
109 – ECOG 
Major exclusion criteria met: 
 
201 – Primary Refractory 
 
202 – Waldenström macroglobulinemia 
 
203 – Multiple myeloma of IgM subtype 
 
204 – POEMS syndrome 
 
205 – Plasma cell leukemia 
 
206 – Primary amyloidosis 
 
207 – Amyloidosis associated with myeloma 
 
208 – Myelodysplastic syndrome 
 
209 – Toxicity with lenalidomide therapy 
 
210 – Prior treatment with pomalidomide 
 
211 – History of other malignancy within past 3 years 
 
212 – Active hepatitis B virus infection 
 
213 – HIV or hepatitis C infection 
 
214 – Graft vs host disease 
 
215 – Cirrhosis 
 
216 – Uncontrolled hypertension 
 
217 – Impaired cardiac function within 4 months 
 
218 – Intolerance to hydration 


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Major treatment non-compliance 
 
501 – Incorrect carfilzomib dose (over dose) 
 
502 – Incorrect carfilzomib dose (under dose) 
 
503 – Carfilzomib dose not adjusted per protocol 
 
504 – Carfilzomib not reduced for 1 cycle before re-escalation 
 
505 – Carfilzomib insufficient infusion time 
 
506 – Carfilzomib dose off schedule 
 
507 – Pomalidomide not administered per protocol 
 
508 – Pomalidomide not withheld per protocol 
 
509 – Dexamethasone not administered per protocol 
 
510 – Compromised IP 
6.6 
Health-related Quality-of-Life or Health Economics Analyses Set(s) 
Not Applicable 
6.7 
Pharmacokinetic/Pharmacodynamic Analyses Set(s) 
The PK/PDn Analysis Set will include a subset of up to 20 evaluable subjects in Safety 
Analysis Set, who have consented to participate in the optional PK/PDn substudy.  
Evaluable subjects are defined as those subjects receiving at least 1 dose of carfilzomib 
and 1 post-dose PK and/or PDn sample collected, as defined by the Schedule of 
Assessments.  These subjects will be evaluated for pharmacokinetics and 
pharmacodynamics unless significant protocol deviations affect data analysis or if key 
dosing, dosing interruption, or sampling information is missing. 
6.8 
Interim Analyses Set(s) 
There are no formal interim analyses planned for this study. 
6.9 
Study-specific Analysis Sets 
Not Applicable 
7. 
Planned Analyses 
7.1 
Primary Analysis 
The primary analysis will be triggered 12 months after the last subject enrollment.  
The primary analysis will be based on a clean database lock. 
7.2 
Sustained MRD Analysis 
A sustained durable MRD analysis is planned after all subjects have had the opportunity 
to complete their 24 months landmark MRD assessments.  The analysis will be based 
on a clean database lock.    


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7.3 
Data Review Team Early Stopping Guidelines 
A data review team (DRT) is a group internal to Amgen, but external to the carfilzomib 
product team(s).  The DRT is composed of members that are external to the study team 
and include a clinician, a safety physician, and a biostatistician.  The DRT will review 
accumulating safety data from the ongoing clinical trial to ensure no avoidable that there 
is no increased risk for harm to subjects.  Membership, procedures, and meeting timing 
will be described in detail in the study DRT charter. 
7.4 
Final Analysis 
The final analysis is planned after all subjects have had the opportunity to complete their 
end of study visit.  The analysis will be based on a clean database lock.  
8. 
Data Screening and Acceptance 
8.1 
General Principles 
The objective of the data screening is to assess the quantity, quality, and statistical 
characteristics of the data relative to the requirements of the planned analyses. 
8.2 
Data Handling and Electronic Transfer of Data 
The Amgen Global Study Operations-Data Management (GSO-DM) department will 
provide all data to be used in the planned analyses. This study will use the RAVE 
database. 
8.3 
Handling of Missing and Incomplete Data 
No imputation for missing data of outcomes will be performed; Sensitivity analyses 
might be needed to evaluate the robustness of the primary analysis. The handling of 
Incomplete dates for the start and stop of adverse event, concomitant medications, new 
antimyeloma therapy, death, prior multiple myeloma therapy, and 
relapse/progression to prior multiple myeloma therapy are described in Appendix A 
8.4 
Detection of Bias 
If applicable the methods to detect bias are described in the analyses of particular 
endpoints. 
8.5 
Outliers 
Pharmacokinetic (PK) plasma concentration data will be evaluated for outliers by visual 
inspection, and decisions to re-assay individual samples will be made in accordance with 
standard pharmacokinetic evaluation practice. 
8.6 
Distributional Characteristics 
Not Applicable 


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8.7 
Validation of Statistical Analyses 
Programs will be developed and maintained, and output will be verified in accordance 
with current risk-based quality control procedures.   
Tables, figures, and listings will be produced with validated standard macro programs 
where standard macros can produce the specified outputs.   
The production environment for statistical analyses consists of Amgen-supported 
versions of statistical analysis software; for example, the SAS System version 9.4 or 
later. 
9. 
Statistical Methods of Analysis 
9.1 
General Considerations 
The analyses of efficacy and safety will be based on the safety analysis set. In principle, 
continuous variables will be summarized by the non-missing sample size (n), mean, 
standard deviation, median, minimum, and maximum.   
Categorical variables will be summarized by the n and percentage in each category.  
Time to event endpoints will be summarized with Kaplan-Meier (KM) curves, KM 
proportions at select time points, KM quartiles (when estimable), the number of subjects 
with events, the number of subjects censored, and censoring reasons.   
Duration of follow-up for time to event endpoints will be estimated using the reverse 
Kaplan Meier method (Schemper and Smith, 1996).  Point estimates for efficacy 
endpoints will be accompanied by 2-sided 90% and 95% CIs including estimates of KM 
quartiles (Klein and Moeschberger, 1997), KM proportions (Kalbfleisch and 
Prentice, 1980), and binomial proportions (Clopper and Pearson, 1934). 
The evaluation of whether the key secondary objective was met will follow a fixed-
sequence approach using the 90% exact confidence interval:  the key secondary 
objective is met only after the primary objective is met. 
9.2 
Subject Accountability 
The following subject disposition information will be summarized descriptively: 
 
Number of screened subjects 
 
Number of subjects screened but not enrolled (screen failures) 
 
Number of subjects enrolled but not dosed 
 
Number of treated subjects (Safety population) 
 
Number (%) of subjects who discontinued treatment and the primary reason for 
discontinuation. The percentage is calculated with respect to Safety population. 


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 
Number (%) of subjects who discontinued study and the primary reason for 
discontinuation. The percentage is calculated with respect to safety population. 
 
Number (%) of subjects who entered long-term follow-up before disease 
progression.  The percentage is calculated with respect to safety population.   
 
Number (%) of subjects who entered long-term follow-up for survival.  The 
percentage is calculated with respect to safety population.  
 
Number (%) of subjects who discontinued each study treatment 
(carfilzomib, dexamethasone, pomalidomide) or end of study due to COVID-
19 control measures 
9.3 
Important Protocol Deviations 
Important Protocol Deviations (IPDs) categories are defined by the study team before 
the first subject’s initial visit and updated during the IPD reviews throughout the study 
prior to database lock.  These definitions of IPD categories, subcategory codes, and 
descriptions will be used during the course of the study.  Eligibility deviations are defined 
in the protocol. The following information of IPD and protocol deviations will be 
summarized, where applicable, with respect to the following: 
 
Number (%) of subjects with IPDs and total number of IPDs will be 
summarized by category and sub-category by treatment arm in Safety 
Analysis Set  
 
Number (%) of subjects with IPDs related to COVID-19 control measures 
will be summarized by treatment arm in Safety Analysis Set 
 
Number (%) of subjects with IPDs related to COVID-19 control measures by 
protocol deviation category (940 series, 950 series and 960 series of 
protocol deviations codes) and by treatment arm in Safety Analysis Set 
 
Subject listing of IPD in Safety Analysis Set, including IPDs related to 
COVID-19 control measures with the descriptions. 
 
Subject listing of IPDs related to COVID-19 control measures based on 
protocol deviations category (940 series, 950 series and 960 series of 
protocol deviations codes) in Safety Analysis Set 
In addition to the summary of IPD, subject listing of inclusion/exclusion deviations 
will also be generated. 


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9.4 
Demographic and Baseline Characteristics 
The following demographic, baseline characteristics and baseline disease characteristics 
will be summarized for the Safety Analysis Set. These includes but not limited to the 
following,  
 
Baseline demographic and Baseline characteristics   
 
Age (years) (as continuous variable; as categorical variable: 18 to < 65, 
65 to < 75, 75 to < 85, ≥ 85 years; <65, >=65; 18-<65, 65-<75, >=75)   
 
Sex (Male, Female)  
 
Ethnicity (Hispanic or Latino, Not Hispanic or Latino) 
 
Race (If multiple races have been reported for a subject, the subject 
will be categorized as multiple race) 
 
Region (Europe, Non-Europe) 
 
Weight (kg)  
 
Height (cm) 
 
Body mass index 
 
Body Surface Area (m2) (as continuous variable; as categorical variable: ≤ 
2.2, > 2.2 m2) 
 
ECOG performance status (0, 1, 2) 
 
Hemoglobin (g/L) (as continuous variable; as categorical variable: < 105, 
≥ 105 g/L) 
 
Absolute Neutrophil count (109/L) (as continuous variable; as categorical 
variable: < 1.5, ≥ 1.5 * 109/L) 
 
Platelet count (109/L) (as continuous variable; as categorical variable: 
< 150, ≥ 150 * 109/L) 
 
Corrected calcium (mg/dL) (as continuous variable; as categorical 
variable: ≤ 11.5, > 11.5 mg/dL) 
 
Creatinine clearance (CrCl, mL/min) (as continuous variable; as 
categorical variable: < 30, 30 - < 50, 50 - < 80, ≥ 80 mL/min) 
Measured or calculated accordingly to the Cockcroft-Gault formula: 
𝐶𝑟𝐶𝑙 (𝑚𝐿/𝑚𝑖𝑛) = (140 −𝐴𝑔𝑒(𝑦𝑒𝑎𝑟𝑠)) × 𝑊𝑒𝑖𝑔ℎ𝑡(𝑘𝑔)
72 × 𝑆𝑒𝑟𝑢𝑚 𝐶𝑟𝑒𝑎𝑡𝑖𝑛𝑖𝑛𝑒(𝑚𝑔/𝑑𝐿)
× (0.85𝑓𝑒𝑚𝑎𝑙𝑒) 
 
Baseline LVEF (%)  
 
Hypertension history (yes, no) 
 
Cardiopulmonary history (yes <by diagnosis category>, no) 
 
Baseline Disease characteristics   
 
ISS stage at baseline (stage I, II, III) 
 
Revised ISS stage at baseline (stage I, II, III) 


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 
Prior lenalidomide treatment (yes, no) 
 
Refractory to prior lenalidomide treatment (yes, no) 
 
Prior PI treatment (yes, no) 
 
Prior anti-CD38 exposure (yes, no) 
 
Refractory to prior anti-CD38 treatment (yes, no) 
 
Prior bortezomib treatment (yes, no) 
 
Refractory to prior bortezomib treatment (yes, no) 
 
Time (month) since initial diagnosis  
 
Type of measurable disease (both SPEP and UPEP, SPEP only, UPEP 
only, Free light chain and abnormal Kappa/Lambda ratio (SFLC) only) 
 
Plasma cell involvement in bone marrow (%)  
 
MM subtype and immunoglobulin heavy chain and Light chain types (IgG, 
IgA, IgD, IgE, IgM, None; Kappa, Lambda, Not detectable within each 
subtype) 
 
Baseline beta2 microglobulin (mg/L) (as continuous variable; as 
categorical variable: < 3.5, 3.5 - < 5.5, ≥ 5.5 mg/L) 
 
Presence of plasmacytoma (yes, no) 
 
Prior Transplant (yes (Autologous, Allogeneic), no)   
 
Prior tobacco use (yes, no) 
 
Number of prior lines of therapy  
 
Cytogenetic risk measured by FISH (high risk (t(4;14), t(14;16), 
deletion 17p), standard risk, missing) 
 
Refractory to the last prior line of therapy  
 
Albumin (g/dL) (as continuous variables; as categorical variable: 
<3.5, >=3.5) 
 
Timing of refractoriness to Lenalidomide (during maintenance: yes vs no) 
 
Time since last relapse (months) 
9.5 
Efficacy Analyses 
 
The primary analyses will be based on the safety analysis set, while sensitivity 
analyses will use different population analysis set listed in Table 9-1. 
Table 9-1.  Primary Efficacy Endpoint Summary Table 
Endpoint 
Primary Summary and Analysis 
Method (Specify Analysis Set if FAS 
is Not Used) 
Sensitivity Analysis 
Overall Response 
Rate (ORR) 
Safety Analysis Set: 
 
Based on Independent 
Review Committee  
Investigator Assessment  
 
Same as per primary 
analysis method 


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Endpoint 
Primary Summary and Analysis 
Method (Specify Analysis Set if FAS 
is Not Used) 
Sensitivity Analysis 
 
rate will be calculated along 
with the associated 90% 
and 95% exact binomial CIs 
that will be estimated using 
the Clopper-Pearson 
method. 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 
based on ORCA 
assessment. 
Per protocol population 
 
Same as per primary 
analysis method 
based on per 
protocol population 
Modified safety population 
 
Same as per primary 
analysis method 
based on modified 
safety population.  
 
Table 9-2.  Secondary Efficacy Endpoint Summary Table 
Endpoint 
Primary Summary and Analysis 
Method (Specify Analysis Set if FAS 
is Not Used) 
Sensitivity Analysis 
MRD[-]CR at a 
sensitivity of 10-5 
using next generation 
sequencing 
(NGS)-based method 
in the bone marrow at 
12 months ± 4 weeks 
from start of 
treatment. 
Safety Analysis Set: 
 
Based on Independent 
Review Committee 
 
The rate will be calculated 
along with the associated 
90% and 95% exact 
binomial CIs that will be 
estimated using the 
Clopper-Pearson method. 
Investigator Assessment  
 
Same as per primary 
analysis method 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 
based on ORCA 
assessment. 
MRD-evaluable analysis 
Set:  
 
Same method as for 
primary analysis will 
be performed. 
Per protocol population 
 
Same as per primary 
analysis method 
based on per 
protocol population 


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Endpoint 
Primary Summary and Analysis 
Method (Specify Analysis Set if FAS 
is Not Used) 
Sensitivity Analysis 
Modified safety population 
 
Same as per primary 
analysis method 
based on modified 
safety population.  
MRD response at a 
sensitivity of 10-5 using 
next generation 
sequencing 
(NGS)-based method in 
the bone marrow at any 
time during therapy 
Safety Analysis Set: 
 
Based on Independent 
Review Committee  
 
The rate will be calculated 
along with the associated 
90% and 95% exact 
binomial CIs that will be 
estimated using the 
Clopper-Pearson method. 
Investigator Assessment  
 
Same as per primary 
analysis method 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 
based on ORCA 
assessment. 
MRD-evaluable analysis 
Set:  
 
Same method as for 
primary analysis will 
be performed. 
Sustained MRD[-]CR  
Safety Analysis Set: 
 
Based on Independent 
Review Committee  
 
The rate will be calculated 
along with the associated 
90% and 95% exact 
binomial CIs that will be 
estimated using the 
Clopper-Pearson method. 
Investigator Assessment  
 
Same as per primary 
analysis method 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 
based on ORCA 
assessment. 
MRD-evaluable analysis 
Set:  
 
Same method as for 
primary analysis will 
be performed.  
Sustained MRD[-]CR 
response at 24 months 
± 4 weeks 
Safety Analysis Set: 
 
Based on Independent 
Review Committee  
 
The rate will be calculated 
along with the associated 
90% and 95% exact 
binomial CIs that will be 
estimated using the 
Clopper-Pearson method. 
Investigator Assessment  
 
Same as per primary 
analysis method 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 


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Endpoint 
Primary Summary and Analysis 
Method (Specify Analysis Set if FAS 
is Not Used) 
Sensitivity Analysis 
based on ORCA 
assessment. 
MRD-evaluable analysis 
Set:  
 
Same method as for 
primary analysis will 
be performed.  
Duration of Response  
Safety Analysis Set: 
 
Based on Independent 
Review Committee  
 
The distribution of DOR 
including the median will be 
characterized using the 
Kaplan-Meier method. 
Investigator Assessment 
 
Same as per primary 
analysis method 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 
based on ORCA 
assessment. 
Time to Response 
Safety Analysis Set: 
 
Based on Independent 
Review Committee  
 
Non-missing sample size 
(n), mean, standard 
deviation, median, 
minimum, and maximum. 
Investigator Assessment 
 
Same as per primary 
analysis method 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 
based on ORCA 
assessment. 
Progression Free 
survival (PFS) 
Safety Analysis Set: 
 
Based on Independent 
Review Committee  
 
The 90% and 95% CIs for 
PFS rate will be reported 
using the methods by 
Kalbfleisch and Prentice 
(1980) with log-log 
transformation. 
 
The distribution of PFS, 
including median, will also 
be estimated using the 
Kaplan-Meier method. 
 
The 90% and 95% CIs for 
the median and other 
percentiles of PFS will be 
constructed using the 
method of Klein and 
Investigator Assessment 
 
Same as per primary 
analysis method 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 
based on ORCA 
assessment. 
Per protocol population 
 
Same as per primary 
analysis method 
based on per 
protocol population 
Modified safety population 


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Endpoint 
Primary Summary and Analysis 
Method (Specify Analysis Set if FAS 
is Not Used) 
Sensitivity Analysis 
Moeschberger (1997) with 
log-log transformation. 
 
Same as per primary 
analysis method 
based on modified 
safety population.  
Overall Survival 
Same method described for PFS. 
Per protocol population 
 
Same as per primary 
analysis method 
described for PFS 
based on per 
protocol population  
Modified safety population 
 
Same as per 
primary analysis 
method described 
for PFS based on 
modified safety 
population. 
Complete Response 
rate or better rate 
Same methods as described for 
ORR. 
Investigator Assessment 
 
Same as per primary 
analysis method 
described for ORR 
based on Investigator 
assessment  
Internal computational 
assessment: 
 
Same as per primary 
analysis method 
described for ORR 
based on ORCA 
assessment. 
Per protocol population 
 
Same as per primary 
analysis method 
described for ORR 
based on per 
protocol population  
Modified safety population 
 
Same as per 
primary analysis 
method described 
for ORR based on 
modified safety 
population. 
 


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9.5.1 
Analyses of Primary Efficacy Endpoint(s)/Estimand(s) 
The primary analyses will be based on the safety analysis set, while the MRD sensitivity 
analyses will be performed on the MRD-evaluable analysis set. 
Overall Response Rate (ORR) 
It will be calculated along with the associated 90% and 95% exact binomial CIs that will 
be estimated using the Clopper-Pearson method. The lower bound of the 90% exact 
binomial CI is evaluated whether it is larger than the reference ORR.  If that 
happens, then the primary objective is met.  
9.5.2 
Analyses of Secondary Efficacy Endpoint(s) 
Key Secondary Efficacy Endpoint:  
MRD[-]CR at sensitivity of 10-5 using NGS-based method in the bone marrow at 
12 months ± 4 weeks from start of treatment. 
The rate will be calculated along with the associated 90% and 95% exact binomial CIs 
that will be estimated using the Clopper-Pearson method. If the primary objective is 
met, then the lower bound of the 90% exact binomial CI is greater than the 
reference MRD[-]CR rate. If that happens, the key secondary objective is met. 
 
Secondary Efficacy Endpoint: 
MRD[-] response at a sensitivity of 10-5 using NGS based method in the bone 
marrow at any time during therapy  
It will be analyzed using the same method as described for the key secondary endpoint. 
Sustained MRD[-]CR 
It will be calculated along with the associated 90% and 95% exact binomial CIs that will 
be estimated using the Clopper-Pearson method.   
Sustained MRD[-]CR at 24 months ± 4 weeks 
It will be calculated along with the associated 90% and 95% exact binomial CIs that will 
be estimated using the Clopper-Pearson method. 
Duration of Response (DOR) 
The distribution of DOR including the median will be characterized using the 
Kaplan-Meier method based on the subjects who achieve best overall response of sCR, 
CR, VGPR or PR. 


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Time to Response 
Time to response will be summarized with the non-missing sample size (n), mean, 
standard deviation, median, minimum, and maximum for responders, ie, subjects who 
achieve best overall response of sCR, CR, VGPR, or PR. 
Progression Free Survival (PFS) 
The distribution of PFS, including median, will be estimated using the Kaplan-Meier 
method. PFS rate at selected time points (12 months and 24 months) will be reported. 
The 90% and 95% CIs for the median and other percentiles of PFS will be constructed 
using the method of Klein and Moeschberger (1997) with log-log transformation. The 
90% and 95% CIs for PFS rates will be estimated using the methods by Kalbfleisch and 
Prentice (1980) with log-log transformation. The subcategory of death with the 
primary reason of COVID-19 infection or COVID-19 pneumonia will be included in 
the PFS events. 
Overall Survival (OS) 
OS will be analyzed using the same method as described for the PFS endpoints. 
Complete Response or better rate (CRR) 
The CR will be analyzed using the same methods as described for ORR. 
9.5.3 
Analyses of Exploratory Efficacy Endpoint(s) 
Assess the depth of MRD  
Percentage of the MRD[-] below the threshold of 10-4, 10-5 and 10-6 by NGS-based 
method at time of suspected CR or better will be summarized. 
PFS by depth of MRD response at:  10-4, 10-5 and 10-6 
The correlation between MRD status and PFS will be explored in the MRD Evaluable 
Analysis Set. In the MRD Evaluable Analysis Set, subjects will be categorized into 
following subgroups: subjects who achieve MRD[-] any time during study and subjects 
who don’t achieve MRD[-] any time during study, subjects who achieve MRD[-]CR any 
time during study and subjects who don’t reach MRD[-]CR any time during study. Within 
each subgroup the distribution of PFS including the median and corresponding 95% CI 
will be summarized descriptively using the Kaplan-Meier method. Three different 
thresholds (10-4, 10-5 and 10-6) will be explored to define MRD status. The Cox 
proportional hazard model will also be fitted with MRD[-] status or MRD[-]CR status as 


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the time-dependent covariate to explore the correlation between MRD status and PFS. 
In addition, similar analysis may be done for MRD response at 12 months and 
24 months landmarks. When there is not a sufficient number of subjects in the 
subgroup, i.e., less than 10% of the MRD population, the analysis will not be 
conducted.  
 
9.6 
Safety Analyses 
9.6.1 
Analyses of Primary Safety Endpoint(s) 
Not applicable.  
9.6.2 
Adverse Events 
The Medical Dictionary for Regulatory Activities (MedDRA) version 20.0 or later will be 
used to code all events categorized as adverse events to a system organ class and a 
preferred term. 
Subject incidence of all treatment-emergent adverse events, serious adverse events, 
grade 3 and above adverse events, Treatment-emergent treatment-related adverse 
events, Treatment-emergent treatment-related serious adverse events, adverse 
events leading to withdrawal of investigational product or other protocol-required 
therapies, and fatal adverse events will be tabulated by system organ class and 
preferred term in alphabetical order.   
Subject incidence of events of interest (standardized MedDRA queries and/or Amgen 
customized queries) will also be summarized according to their categories and preferred 
term.  
In addition, summaries of treatment-emergent adverse events, serious adverse events, 
grade 3 or higher adverse events, Treatment-emergent treatment-related  adverse 
events, Treatment-emergent treatment-related serious adverse events, adverse 
events leading to withdrawal from investigational product or other protocol-required 
therapies, and fatal adverse event of the subjects by preferred term will be provided in 
descending order of frequency.   
Summaries of treatment-emergent adverse events, Treatment-emergent treatment-
related adverse events, Treatment-emergent treatment-related serious adverse 
events and serious adverse events will be tabulated by system organ class, preferred 
term, and grade. Fatal adverse events by system organ class and preferred term will 
also be provided in descending order of frequency 


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A summary of the number of deaths and the cause of death, classified by deaths within 
30 days of last dose of study drug and deaths more than 30 days after the last dose, will 
be provided.  
9.6.3 
Laboratory Test Results 
The laboratory test results and their change from baseline will be summarized by cycle. 
Actual value and change from baseline of hematology, chemistry, and other laboratory 
values will be summarized by cycle. For the summary of changes from baseline values, 
subjects without baseline and/or post baseline values will be excluded. Laboratory 
assessments collected > 30 days after the last dose will not be included in the 
summaries.  
Selected laboratory test results will be assigned toxicity grades using CTCAE 5. Shift 
tables assessing the toxicity grade at baseline versus worst toxicity on study and to the 
last value recorded on study will be presented for selected laboratory test results. A 
listing of all grade 3 or higher laboratory values will be provided.  
The laboratory analytes in the study are given below. 


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Local Laboratory: 
Chemistry 
Local Laboratory: 
Hematology 
Local Laboratory: 
Disease 
Assessments 
Other Labs 
Sodium 
Potassium 
Chloride 
Bicarbonate/CO2  
Total protein 
Albumin 
Calcium 
Adjusted/corrected 
calcium 
Glucose  
BUN or Urea 
Creatinine 
Uric acid 
Total bilirubin 
Direct bilirubin 
ALP 
LDH 
AST (SGOT) 
ALT (SGPT) 
Phosphorus 
Amylase 
Lipase 
HbA1c 
Fasting glucose 
(screening) 
Fasting lipid panel: 
 Cholesterol 
 HDL 
 LDL 
 Triglycerides 
ANC 
RBC 
Hemoglobin 
Hematocrit 
MCV  
MCH 
MCHC 
RDW 
Platelets 
WBC 
Differential  
*(including 
manual) 
• Plasma Cells 
• Bands/stabs 
• Eosinophils 
• Basophils 
• Lymphocytes 
• Monocytes  
• Segmented 
Neutrophils 
FISH (bone marrow 
aspirate) 
SPEP 
SIFE 
UPEP 
UIFE 
SFLC 
Local Laboratory:  
Urinalysis: 
• Specific Gravity 
• pH 
• Blood 
• Glucose 
• Ketones 
• Protein 
• Bilirubin 
• WBC 
• RBC 
• Bacteria 
• Casts 
• Crystals 
Central Laboratory:  
PK (optional) 
PDn (optional) 
PG (optional) 
Biomarker samples 
(optional) 
MRD assessment by 
NGS (bone marrow 
aspirate) 
Local Laboratory: 
Serum or urine 
Pregnancy 
Quantitative 
immunoglobulins (serum): 
 IgA, IgD, IgE, IgG, IgM 
beta2-microglobulin 
(serum) 
NT-proBNP (or if 
unavailable, BNP) 
HBV serology  
Hepatitis B DNA  
Local Laboratory: 
Coagulation 
 
PT/INR 
APTT 
 
 
9.6.4 
Vital Signs 
The vital sign results including systolic/ diastolic blood pressure, heart rate, temperature, 
and if available, respiratory rate and oxygen saturation and their change from baseline 
will be summarized by cycle. For the summary of changes from baseline by visit, 
subjects without a baseline and/or post baseline value will be excluded; values from 
unscheduled assessments will be excluded. Vital sign results taken > 30 days after the 
last administration of protocol therapy will be excluded from all vital sign summaries. 


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9.6.5 
Physical Measurements 
The physical measurements weight, BSA and their change from baseline will be 
summarized by cycle. Body surface area (BSA) should be calculated using the Mosteller 
Formula (Mosteller, 1987): 
BSA (m2) = ([height (cm) × weight (kg)] / 3600) ½. 
9.6.6 
Electrocardiogram 
The ECG measurements from this clinical study are performed as per standard of care 
for routine safety monitoring, rather than for purposes of assessment of potential QTc 
effect.  Since these evaluations may not necessarily be performed under the rigorous 
conditions expected to lead to meaningful evaluation of QTc data; summaries and 
statistical analyses of ECG measurements are not planned, and these data would not be 
expected to be useful for meta-analysis with data from other trials. 
9.6.7 
Antibody Formation 
Not Applicable 
9.6.8 
Exposure to Investigational Product 
Descriptive statistics will be produced to describe the exposure to investigational 
product. The extent of exposure to investigational products (carfilzomib and 
pomalidomide) will be evaluated with respect to treatment duration, number of cycles 
started, total dose received, average dose received, number of doses administered, and 
dose intensity.  The reasons for dose modification or discontinuation from any study 
treatment will be summarized. If the reason for dose modification is COVID-19 
control measures which is recorded in the specified filed (Other) on the CRF, then 
the number (%) with COVID-19 control measures will also be presented. The 
summary will include the following:  
 
Number (%) of subjects with doses missed, dose delays, dose reductions, and dose 
interruptions for carfilzomib will be summarized.  
 
Number of doses missed, delayed, reduced, and interrupted per subject  
 
Primary reasons for dose missed, delays, reductions, and interruptions. 
 
Number (%) of subjects with doses missed, dose delays, dose reductions, and dose 
interruptions for pomalidomide.  
 
Number of doses missed, delayed, reduced, and interrupted per subject  
 
Primary reasons for dose missed, delays, reductions, and interruptions. 


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 Some variables of interest ie, treatment duration, number of cycles started, total dose 
received, number of doses administered, and dose intensity are defined in the section 5.  
 
Number (%) of subjects dosed by cycle for any study drug, each study drug and all 
study drugs  
9.6.9 
Exposure to Non-investigational Product 
Descriptive statistics will be produced to describe the exposure to non-
investigational product. The extent of exposure to non-investigational product 
(dexamethasone) will be evaluated with respect to treatment duration, number of 
cycles started, total dose received, average dose received, number of doses 
administered, and dose intensity.  The reasons for dose modification or 
discontinuation from any study treatment will be summarized. If the reason for 
dose modification is COVID-19 control measures which is recorded in the 
specified field (Other) on the CRF, then the number () with COVID-19 control 
measures will also be presented. The summary will include the following:  
 
Number () of subjects with doses missed, dose delays, dose reductions, and 
dose interruptions for dexamethasone.  
 
Number of doses missed, delayed, reduced, and interrupted per subject  
 
Primary reasons for dose missed, delays, reductions, and interruptions. 
Some variables of interest ie, treatment duration, number of cycles started, total 
dose received, number of doses administered, and dose intensity are defined in 
the section 5.  
 
9.6.10 
Exposure to Other Protocol-required Therapy 
Not applicable. 
9.6.11 
Exposure to Concomitant Medication 
Number and proportion of subjects receiving therapies of interest will be summarized by 
preferred term for each treatment group as coded by the World Health Organization 
Drug dictionary. 
9.7 
Other Analyses 
Echocardiogram, including LVEF will be summarized by actual values and changes from 
baseline values by visit using descriptive statistics. 


Product:  Carfilzomib 
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Pulmonary Function Tests, including spirometry and DLCO, will be summarized by 
actual values and changes from baseline values by visit using descriptive statistics. 
9.7.1 
Analyses of Pharmacokinetic or Pharmacokinetic/Pharmacodynamic 
Endpoints 
Carfilzomib PK parameters (maximum observed concentration [Cmax], area under the 
concentration-time curve [AUC], and if feasible, terminal half-life [t1/2]) will be estimated 
from plasma concentration-time profiles obtained from subjects enrolled in the optional 
PK/PDn substudy.  Additional analyses may be performed to evaluate relationships 
between carfilzomib PK and selected safety or efficacy endpoints.   
For carfilzomib PDn parameters, proteasome activity for the chymotrypsin-like, 
trypsin-like and caspase-like activities from whole blood will be reported for the 
scheduled timepoints to determine if carfilzomib treatment produces a pharmacodynamic 
reduction in proteasome activity relative to baseline activity levels. 
PK/PDn analyses will be provided by the Department of Clinical Pharmacology, 
Modeling & Simulation (CPMS) (PK analyses) and Clinical Biomarkers and Diagnostics 
(CBD) (PDn analyses). Details regarding the analyses will be provided in a separate 
population modeling analysis plan by CPMS and CBD. 
9.7.2 
Analyses of Clinical Outcome Assessments 
Not Applicable 
9.7.3 
Analyses of Health Economic Endpoints 
Not Applicable  
9.7.4 
Analyses of Biomarker Endpoints 
Not Applicable 
 
10. 
Changes From Protocol-specified Analyses 
The Per Protocol Set(s) is added in section 6.3 and it includes subjects who do not 
have important protocol deviations that might affect the interpretation of the 
analyses of the efficacy endpoints. 
Per the protocol amendment 4 (section 10.2.4), incomplete dates for the start of 
adverse event, concomitant medications, and death will be imputed and the 
detailed rules will be specified in the statistical analysis plan. 


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Addition to the start dates, stop of adverse event, concomitant medications, new 
antimyeloma therapy, death, prior multiple myeloma therapy, and 
relapse/progression to prior multiple myeloma therapy will be imputed by the 
algorithms (section 8.3). 
Impact analyses of COVID-19 on the overall trail conduct and assessment of 
safety and efficacy parameters are added in the statistical analysis plan. 
SAP contains some changes in subgroups (section 4.2) from Protocol. 
 
Added below subgroups for primary endpoint: 
− 
Cytogenetic risk measured by FISH (high risk (t(4;14), t(14;16), deletion 
17p), standard risk) 
− 
R-ISS (stage I, stage II, stage III) 
− 
Prior anti-CD38 exposure (yes, no) 
− 
Refractory to prior anti-CD38 treatment (yes, no) 
− 
Prior bortezomib exposure (yes, no) 
− 
Refractory to prior bortezomib treatment (yes, no) 
 
Added below subgroups for PFS: 
− 
prior carfilzomib exposure (yes, no)  
− 
number of prior lines of therapy (1, 2) 
− 
timing of lenalidomide refractoriness (during maintenance: yes, no) 
− 
Cytogenetic risk measured by FISH (high risk (t(4;14), t(14;16), deletion 
17p), standard risk) 
− 
R-ISS (stage I, stage II, stage III) 
− 
Prior anti-CD38 exposure (yes, no) 
− 
Refractory to prior anti-CD38 treatment (yes, no) 
− 
Prior bortezomib exposure (yes, no) 
− 
Refractory to prior bortezomib treatment (yes, no) 
 


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11. 
Literature Citations / References 
Clopper CJ, Pearson ES.  The use of confidence or fiducial limits illustrated in the case 
of the binomial.  Biometrika.  1934;26:404–416. 
Greipp PR, San Miguel J, Durie BG, et al. International staging system for multiple 
myeloma. J Clin Oncol. 2005;23(15):3412–20. 
Kalbfleisch JD, Prentice RL.  The statistical analysis of failure time data.  John Wiley & 
Sons, Inc., New York, 1980. 
Klein JP and Moeschberger ML.  Survival Analysis:  Techniques for Censored and 
Truncated Data.  Springer, 1997. 
Mosteller RD.  Simplified calculation of body-surface area.  N Engl J Med.  
1987;317(17):1098. 
Palumbo A, Avet-Loiseau H, Oliva S, et al. Revised International Staging System 
for Multiple Myeloma: a report from International Myeloma Working Group, J Clin 
Oncol, 33 (26) (2015), pp. 2863–2869 
Siegel DS, Dimopoulos MA, Ludwig H, et al.  Improvement in Overall Survival With 
Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory 
Multiple Myeloma.  J Clin Oncol.  2018;36:728-734.  


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12. 
Prioritization of Analyses 
Not Applicable 


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13. 
Appendices 


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Protocol Number:  20180117 
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Appendix A.  Handling of Dates, Incomplete Dates and Missing Dates 
A1. Imputation Rules for Adverse Events and Concomitant Medications (other 
than the new anti-myeloma therapy) dates 
Imputation Rules for Partial or Missing Start Dates 
The reference date for the following rules is the date of first dose. 
 
 
 
 
 
Start Date 
Stop Date 
Complete: 
yyyymmdd 
Partial: 
yyyymm 
Partial: 
yyyy 
Missing 
< 1st 
dose 
≥ 1st 
dose 
< 1st 
dose 
yyyym
m 
≥ 1st 
dose 
yyyy
mm 
< 1st 
dose 
yyyy 
≥ 1st 
dose 
yyyy 
 
 
Partial: 
yyyym
m 
= 1st 
dose 
yyyymm 
 
2 
1 
n/a 
1 
n/a 
1 
1 
≠ 1st 
dose 
yyyymm 
2 
2 
2 
2 
2 
2 
Partial: 
yyyy 
= 1st 
dose 
yyyy 
 
3 
1 
 
3 
1 
n/a 
1 
1 
≠ 1st 
dose 
yyyy 
3 
3 
3 
3 
3 
Missing 
4 
1 
4 
1 
4 
1 
1 
1=Impute the date of first dose; 2=Impute the first of the month; 3=Impute January 1 of the year; 
4=Impute January 1 of the stop year 
Note: For subjects who were never treated (first dose date is missing), partial start dates will be set 
to the first day of the partial month or first day of year if month is also missing. 
Imputation Rules for Partial or Missing Stop Dates 
Initial imputation 
 
If the month and year are present, impute the last day of that month. 
 
If only the year is present, impute December 31 of that year. 
 
If the stop date is entirely missing, assume the event or medication is ongoing. 
 
If the imputed stop date is before the start date, set stop date to missing. 


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 
If the imputed stop date is after the death date, impute as death date. 
 
A2. Imputation Rules for New Antimyeloma Therapy Start Date  
If the start day of new antimyeloma therapy is missing and month and year are not 
the same as last dosing date of study treatment, it will be assumed to be the first 
day of the month. If the start day of new antimyeloma therapy is missing and 
month and year are same as last dosing date of study treatment, the start date will 
be assumed as last dosing date of study treatment. In other situations, do not 
impute. 
A3. Imputation Rules for Partial or Missing Death Dates 
If death year and month are available but day is missing: 
 
If yyyymm for the date last known to be alive equals yyyymm for death date, 
set death date to the day after the date last known to be alive. 
 
If yyyymm for the date last known to be alive is less than the yyyymm for death 
date, set death date to the first day of the death month. 
 
If yyyymm for the date last known to be alive is greater than yyyymm for death 
date, assume death date is in error, do not impute and censor the subject 
survival time. 
If month and day are missing and year of death is known: 
 
If yyyy for the date last known to be alive equals yyyy for death date, set death 
date to the day after last known to be alive date. 
 
If yyyy for the date last known to be alive is less than yyyy for death date, set 
death date to the first day of the death year. 
 
If yyyy for the date last known to be alive is greater than yyyy for death date, 
assume death date is in error, do not impute and censor the subject survival 
time. 
If a death date is totally missing: 
Do not impute and censor the subject survival time. 
 
A4. Imputation Rules for Dates of Prior Multiple Myeloma Therapy and 
Relapse/progression to Prior Multiple Myeloma Therapy: 
If the day of prior multiple myeloma therapy or relapse/progression to prior 
multiple myeloma therapy is missing but month and year are available, then 
impute the date to 15th of the month. If month or year is missing or the date is 
completely missing, do not impute.