Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Conditions
Keywords
Carfilzomib, Dexamethasone, Daratumumab
Brief summary
Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.
Detailed description
This is a phase 3 multicenter, open-label, randomized study in participants with relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior therapies. Participants receive the treatment determined by randomization for a maximum of approximately 5 years, up to 30 days prior to the final analysis data cutoff (DCO) date or until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). No crossover between the treatment arms is allowed. This was an open-label study. However, the assessment of response and disease progression for the primary analysis was determined by an Independent Review Committee (IRC) in a blinded manner. Sensitivity analyses of response and disease progression were determined centrally by the sponsor using a validated computer algorithm (Onyx Response Computational Assessment \[ORCA\]) in a blinded manner. Following progression or discontinuation of study drug(s), participants will have 1 follow-up visit (30 days \[+3} after last dose of all study drug\[s\]). After disease progression, data on survival status and subsequent antimyeloma therapy will be gathered at long-term follow-up (LTFU) visits every 12 weeks (+/-2 weeks) until the Final Analysis DCO.
Interventions
DRUGDexamethasone
Commercially available oral and IV formulas were obtained by investigative sites. Amgen supplied IV or PO dexa for some countries (Poland, Hungry, Romania, Bulgaria, Korea). Dosage modification rules applied based on participant age (participants \> 75 years were given lower doses), dexa-related toxicities, and discontinuation of carfilzomib.
DRUGDaratumumab
Daratumumab was supplied as a concentrated solution for infusion in single-use vials.
DRUGCarfilzomib
Carfilzomib for infusion was supplied as a lyophilized, sterile product in single-use vials. The lyophilized product was reconstituted with preservative-free sterile water for injection, the reconstituted solution contained carfilzomib 2 mg/mL. IV injections lasted approximately 30 minutes. Dose could be modified based on a \>20% change in body weight or toxicity.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Criteria 1 Relapsed or progressive multiple myeloma after last treatment * Criteria 2 Males or females ≥ 18 years of age * Criteria 3 Measurable disease with at least 1 of the following assessed within 21 days prior to randomization: * IgG multiple myeloma: serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL, * IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL, * urine M-protein ≥ 200 mg/24 hours, * in subjects without measurable serum or urine M- protein, serum free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio * Criteria 4 Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy * Criteria 5 Prior therapy with carfilzomib is allowed as long as the patient had at least a partial response (PR) to most recent therapy with carfilzomib, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not proteasome inhibitors or CD38 antibodies during this 6-month carfilzomib treatment free interval) * Criteria 6 Prior therapy with anti-CD38 antibodies is allowed as long as the patient had at least a PR to most recent therapy with CD38 antibody, was not removed due to toxicity, did not relapse within 60 days from intensive treatment (at least every other week) of CD38 antibody therapy, and will have at least a 6 month CD38 antibody treatment-free interval from last dose received until first study treatment * Other inclusion criteria may apply
Exclusion criteria
* Criteria 1 Waldenström macroglobulinemia * Criteria 2 Multiple myeloma of IgM subtype * Criteria 3 POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Criteria 4 Plasma cell leukemia (\> 2.0 \* 10\^9/L circulating plasma cells by standard differential) * Criteria 5 Myelodysplastic syndrome * Criteria 6 Known moderate or severe persistent asthma within the past 2 years * Criteria 7 Known chronic obstructive pulmonary disease (COPD) with a FEV1 \< 50% of predicted normal * Criteria 8 Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT interval (QTc) of \> 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks | Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). The duration of PFS was right censored for participants who met any of the following conditions: 1. no baseline/post-baseline disease assessments; 2. started a new anti myeloma therapy before documentation of progressive disease or death; 3. progressive disease or death immediately after more than 70 days without disease assessment visit or; 4. alive without documentation of disease progression before the analysis trigger date (PA DCO); 5. lost to follow-up or withdrawn consent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee | 12 Months (8- to 13-month window) | MRD\[-\]CR at 12 months was defined as achievement of CR per IMWG-URC by IRC and MRD\[-\] status as assessed by next-generation sequencing (NGS; at a 10\^-5 level) at the 12 months landmark (8 to 13 month window). |
| Overall Survival | Up to 58 months after the first participant was enrolled (at FA DCO, a median of 40.29 weeks of treatment [any study drug] in the Kd group and 79.29 weeks of treatment [any study drug] in the KdD group; FA DCO was 15 Apr 2022) | Overall survival was defined as the time from randomization until death from any cause. Deaths collected via public source, after end of study were included. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive were censored at the date last known to be alive. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks | Treatment-emergent adverse events are defined as any adverse event with an onset after the administration of the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurs earlier. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal. Treatment-related adverse events are treatment-emergent adverse events considered related to at least one study drug by the investigator, including those with unknown relationship. |
| Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only) | From Day 1 until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks | Duration of response (DOR) was defined as the time (in months) from first evidence of partial response (PR) or better per IMWG-URC by IRC to the earlier of disease progression or death due to any cause for participants with a best response of PR or better. For those who are alive and have not experienced disease progression at the time of data cutoff for analysis, duration of response was right-censored. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. |
| Kaplan-Meier Estimate for Time to Next Treatment (TTNT) | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks | Time to next treatment was defined as the time (in months) from randomization to the initiation of subsequent non-protocol anti-cancer treatment for multiple myeloma. Time to next treatment for participants who do not start the subsequent treatment for multiple myeloma was censored at the date when the participant's information was last available. Medians of TTNT duration were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. |
| Kaplan-Meier Estimates for Time to Progression (TTP) as Assessed by the Independent Review Committee (PA DCO Only) | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks | Time to progression was defined as the time (in months) from randomization to documented disease progression. Participants who did not have documented disease progression were censored at the date when data was last available. |
| Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only) | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks | Overall response rate was defined as the percentage of participants in each treatment group who achieve partial response (PR) or better per the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) as their best response. Complete Response (CR): No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-component with urine M-component \<100 mg/24 hours. Partial Response (PR): ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to \< 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. 95% CIs for proportions were estimated using the Clopper-Pearson method. |
| Time to Overall Response as Assessed by the Independent Review Committee (PA DCO Only) | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks | Time to overall response was defined as the time from randomization to the earliest date a response of partial response (PR) or better as per IMWG-URC is first achieved and subsequently confirmed for participants with a best response of PR or better. |
| Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks | A measure of the persistence of the CR (includes strict CR) per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD\[-\] status as assessed by next-generation sequencing (NGS; at a 10\^-5 level) for 12 months or more after achieving MRD\[-\]CR status. 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method. |
| Percentage of Participants With a Complete Response (CR) as Assessed by the Independent Review Committee (PA DCO Only) | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks | The percentage of participants in each treatment group who achieved stringent complete response (sCR) or CR per IMWG-URC, as assessed by the IRC, as their best response is presented. |
| Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months | 12 Months (8- to 13-month window) | MRD\[-\] at 12-month was defined as achievement of MRD\[-\] status as assessed by next-generation sequencing (NGS; at a 10\^-5 level) at the 12 months landmark (from 8 months to 13 months window). 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method. |
| Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO) | Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. QLQ-C30 questionnaire was administered prior to dosing every 28 ± 7 days starting from cycle 1 day 1 through first follow-up visit (30 days \[+3\] after last dose of all study drugs). |
| Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | Randomization to Months 3, 6, 12, and 18 | Time to progression was defined as the time (in months) from randomization to documented disease progression. This outcome reports TTP as the percentage of participants who were event free (that is, they had not had disease progression) at the specified time frames. Independent Review Committee assessment for this outcome measure was not planned after the primary analysis. 95% CIs for event-free rates were estimated using the method by Kalbfleisch and Prentice (1980) with log-log transformation. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Greece, Hungary, Japan, Poland, Romania, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
This study was conducted at 102 centers. 569 participants were screened and 466 were enrolled. Primary analysis (PA) data cutoff (DCO): 14-Jul-2019. Final analysis (FA) DCO: 15-Apr-2022.
Pre-assignment details
Participants were randomized in 1:2 ratio to arms KD vs KdD after being stratified by 1) International Staging System (ISS) stage (Stage 1-2 vs Stage 3) at screening, 2) prior proteasome inhibitor exposure (yes/no), 3) number of prior lines of therapy (1 vs ≥ 2), and 4) prior cluster differentiation antigen 38 (CD38) antibody therapy (yes/no).
Participants by arm
| Arm | Count |
|---|---|
| Kd - Carfilzomib and Dexamethasone Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.
Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. | 154 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.
Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.
Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only. | 312 |
| Total | 466 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 74 | 142 |
| Overall Study | Decision by sponsor | 13 | 37 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Withdrawal by Subject | 14 | 28 |
Baseline characteristics
| Characteristic | Kd - Carfilzomib and Dexamethasone | Total | KdD - Carfilzomib, Dexamethasone and Daratumumab |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 9.6 | 63.4 years STANDARD_DEVIATION 9.9 | 62.9 years STANDARD_DEVIATION 10 |
| Age, Customized 18 - 64 years | 77 Participants | 240 Participants | 163 Participants |
| Age, Customized 65 - 74 years | 55 Participants | 176 Participants | 121 Participants |
| Age, Customized 75 - 84 years | 22 Participants | 50 Participants | 28 Participants |
| Age, Customized >=85 years | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Disease status 0 or 1 | 147 Participants | 442 Participants | 295 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Disease status 2 | 7 Participants | 22 Participants | 15 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Missing | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 8 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 146 Participants | 437 Participants | 291 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 21 Participants | 14 Participants |
| Frailty Status as Assessed by Investigator Fit | 68 Participants | 244 Participants | 176 Participants |
| Frailty Status as Assessed by Investigator Frail | 9 Participants | 19 Participants | 10 Participants |
| Frailty Status as Assessed by Investigator Intermediate fitness | 36 Participants | 90 Participants | 54 Participants |
| Frailty Status as Assessed by Investigator Missing | 4 Participants | 10 Participants | 6 Participants |
| Frailty Status as Assessed by Investigator Not available | 37 Participants | 103 Participants | 66 Participants |
| Geographic Regions Asia Pacific | 39 Participants | 123 Participants | 84 Participants |
| Geographic Regions Europe | 103 Participants | 310 Participants | 207 Participants |
| Geographic Regions North America | 12 Participants | 33 Participants | 21 Participants |
| Race/Ethnicity, Customized Asian | 20 Participants | 66 Participants | 46 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 9 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 25 Participants | 16 Participants |
| Race/Ethnicity, Customized White | 123 Participants | 366 Participants | 243 Participants |
| Risk Group as Determined by Fluorescent in situ Hybridization (FISH) High risk | 26 Participants | 74 Participants | 48 Participants |
| Risk Group as Determined by Fluorescent in situ Hybridization (FISH) Standard risk | 56 Participants | 164 Participants | 108 Participants |
| Risk Group as Determined by Fluorescent in situ Hybridization (FISH) Unknown | 72 Participants | 228 Participants | 156 Participants |
| Sex: Female, Male Female | 63 Participants | 198 Participants | 135 Participants |
| Sex: Female, Male Male | 91 Participants | 268 Participants | 177 Participants |
| Stratification Factor: International Staging System (ISS) Stage per IxRS Stage III | 27 Participants | 87 Participants | 60 Participants |
| Stratification Factor: International Staging System (ISS) Stage per IxRS Stage I or II | 127 Participants | 379 Participants | 252 Participants |
| Stratification Factor: Lines of Prior Treatment per IxRS 1 prior treatment | 67 Participants | 200 Participants | 133 Participants |
| Stratification Factor: Lines of Prior Treatment per IxRS > = 2 prior treatments | 87 Participants | 266 Participants | 179 Participants |
| Stratification Factor: Prior CD38 Antibody Therapy per IxRS No | 154 Participants | 465 Participants | 311 Participants |
| Stratification Factor: Prior CD38 Antibody Therapy per IxRS Yes | 0 Participants | 1 Participants | 1 Participants |
| Stratification Factor: Prior Proteasome Inhibitor Treatment per IxRS No | 15 Participants | 48 Participants | 33 Participants |
| Stratification Factor: Prior Proteasome Inhibitor Treatment per IxRS Yes | 139 Participants | 418 Participants | 279 Participants |
| Time from Initial Diagnosis to Randomization | 44.03 months STANDARD_DEVIATION 36.57 | 46.58 months STANDARD_DEVIATION 35.34 | 47.86 months STANDARD_DEVIATION 34.69 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 80 / 154 | 148 / 312 |
| other Total, other adverse events | 137 / 153 | 295 / 308 |
| serious Total, serious adverse events | 80 / 153 | 211 / 308 |
Outcome results
Primary
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only)
Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). The duration of PFS was right censored for participants who met any of the following conditions: 1. no baseline/post-baseline disease assessments; 2. started a new anti myeloma therapy before documentation of progressive disease or death; 3. progressive disease or death immediately after more than 70 days without disease assessment visit or; 4. alive without documentation of disease progression before the analysis trigger date (PA DCO); 5. lost to follow-up or withdrawn consent.
Time frame: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Population: Intent to Treat Population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) | Participants with PFS events | 68 Participants |
| Kd - Carfilzomib and Dexamethasone | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) | Participants who were censored | 86 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) | Participants with PFS events | 110 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) | Participants who were censored | 202 Participants |
Comparison: Stratification factors used in the Log-rank p-value (1-sided) and the Cox model hazard ratio (KdD/Kd) were as assessed at randomization: International Staging System stage at screening (Stage 1 or 2 vs Stage 3); prior proteasome inhibitor exposure (yes vs no); number of prior lines of therapy (1 vs \>= 2).p-value: 0.001495% CI: [0.464, 0.854]Log Rank
Secondary
Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only)
Duration of response (DOR) was defined as the time (in months) from first evidence of partial response (PR) or better per IMWG-URC by IRC to the earlier of disease progression or death due to any cause for participants with a best response of PR or better. For those who are alive and have not experienced disease progression at the time of data cutoff for analysis, duration of response was right-censored. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Time frame: From Day 1 until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Population: Participants who responded in the Intent to Treat Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only) | 16.6 months |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only) | NA months |
Secondary
Kaplan-Meier Estimate for Time to Next Treatment (TTNT)
Time to next treatment was defined as the time (in months) from randomization to the initiation of subsequent non-protocol anti-cancer treatment for multiple myeloma. Time to next treatment for participants who do not start the subsequent treatment for multiple myeloma was censored at the date when the participant's information was last available. Medians of TTNT duration were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Time frame: PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Kaplan-Meier Estimate for Time to Next Treatment (TTNT) | FA DCO | 17.8 months |
| Kd - Carfilzomib and Dexamethasone | Kaplan-Meier Estimate for Time to Next Treatment (TTNT) | PA DCO | 17.3 months |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Kaplan-Meier Estimate for Time to Next Treatment (TTNT) | PA DCO | NA months |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Kaplan-Meier Estimate for Time to Next Treatment (TTNT) | FA DCO | 37.4 months |
Secondary
Kaplan-Meier Estimates for Time to Progression (TTP) as Assessed by the Independent Review Committee (PA DCO Only)
Time to progression was defined as the time (in months) from randomization to documented disease progression. Participants who did not have documented disease progression were censored at the date when data was last available.
Time frame: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Population: Intent to Treat Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Kaplan-Meier Estimates for Time to Progression (TTP) as Assessed by the Independent Review Committee (PA DCO Only) | 17.5 months |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Kaplan-Meier Estimates for Time to Progression (TTP) as Assessed by the Independent Review Committee (PA DCO Only) | NA months |
Secondary
Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee
MRD\[-\]CR at 12 months was defined as achievement of CR per IMWG-URC by IRC and MRD\[-\] status as assessed by next-generation sequencing (NGS; at a 10\^-5 level) at the 12 months landmark (8 to 13 month window).
Time frame: 12 Months (8- to 13-month window)
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee | 1.9 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee | 12.8 percentage of participants |
Comparison: Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.95% CI: [2.364, 25.858]
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent adverse events are defined as any adverse event with an onset after the administration of the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurs earlier. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal. Treatment-related adverse events are treatment-emergent adverse events considered related to at least one study drug by the investigator, including those with unknown relationship.
Time frame: PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: All TEAEs | 149 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Treatment-related TEAEs | 129 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Severity Grade >=3 | 120 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Leading to discon of carfilzomib | 33 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Serious Adverse Events | 80 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related TEAEs: Grade >=3 | 74 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Leading to discontinuation of carfilzomib | 37 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Severity Grade >=3 | 113 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Leading to discontinuation of daratumumab | NA Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related and serious TEAEs | 32 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Leading to discon of dexamethasone | 40 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Leading to discon of daratumumab | NA Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Fatal TEAEs | 11 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related TEAEs: discon of carfilzomib | 21 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Treatment-related TEAEs | 131 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Fatal TEAEs | 8 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related TEAEs: Grade >=3 | 82 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related TEAEs: discon of daratumumab | NA Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related and serious TEAEs | 34 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Leading to discon of dexamethasone | 37 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related TEAEs: discon of carfilzomib | 22 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related TEAEs: discon of dexamethasone | 24 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related TEAEs: discon of daratumumab | NA Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Serious Adverse Events | 70 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related TEAEs: discon of dexamethasone | 24 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related Fatal TEAEs | 0 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related Fatal TEAEs | 0 Participants |
| Kd - Carfilzomib and Dexamethasone | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: All TEAEs | 147 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related Fatal TEAEs | 5 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Severity Grade >=3 | 253 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Serious Adverse Events | 173 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Leading to discon of carfilzomib | 65 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Leading to discon of daratumumab | 28 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: TEAEs: Leading to discon of dexamethasone | 33 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Fatal TEAEs | 30 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Treatment-related TEAEs | 260 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related TEAEs: Grade >=3 | 187 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related and serious TEAEs | 84 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related TEAEs: discon of carfilzomib | 50 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related TEAEs: discon of daratumumab | 15 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related TEAEs: discon of dexamethasone | 19 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: Related Fatal TEAEs | 5 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: All TEAEs | 306 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Severity Grade >=3 | 273 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Serious Adverse Events | 211 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Leading to discontinuation of carfilzomib | 98 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Leading to discontinuation of daratumumab | 43 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: TEAEs: Leading to discon of dexamethasone | 58 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Fatal TEAEs | 39 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Treatment-related TEAEs | 267 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related TEAEs: Grade >=3 | 206 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related and serious TEAEs | 102 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related TEAEs: discon of carfilzomib | 69 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related TEAEs: discon of daratumumab | 18 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | FA DCO: Related TEAEs: discon of dexamethasone | 30 Participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | PA DCO: All TEAEs | 306 Participants |
Secondary
Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only)
Overall response rate was defined as the percentage of participants in each treatment group who achieve partial response (PR) or better per the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) as their best response. Complete Response (CR): No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-component with urine M-component \<100 mg/24 hours. Partial Response (PR): ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to \< 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. 95% CIs for proportions were estimated using the Clopper-Pearson method.
Time frame: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only) | 74.7 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only) | 84.3 percentage of participants |
Comparison: Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.~P-values were calculated using the stratified Cochran-Mantel-Haenszel Chi-Square test.p-value: 0.00495% CI: [1.184, 3.129]Cochran-Mantel-Haenszel
Secondary
Overall Survival
Overall survival was defined as the time from randomization until death from any cause. Deaths collected via public source, after end of study were included. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive were censored at the date last known to be alive.
Time frame: Up to 58 months after the first participant was enrolled (at FA DCO, a median of 40.29 weeks of treatment [any study drug] in the Kd group and 79.29 weeks of treatment [any study drug] in the KdD group; FA DCO was 15 Apr 2022)
Population: Intent to Treat Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Overall Survival | 43.6 months |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Overall Survival | 50.8 months |
Comparison: Hazard ratio and corresponding 95% CIs were estimated using the stratified Cox proportional hazards models.~1-sided p-value from the log-rank test controlling for the randomization stratification factors.p-value: 0.041795% CI: [0.595, 1.033]Log Rank
Secondary
Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More
A measure of the persistence of the CR (includes strict CR) per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD\[-\] status as assessed by next-generation sequencing (NGS; at a 10\^-5 level) for 12 months or more after achieving MRD\[-\]CR status. 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method.
Time frame: PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More | PA DCO | 0.0 percentage of participants |
| Kd - Carfilzomib and Dexamethasone | Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More | FA DCO | 0.0 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More | PA DCO | 0.0 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More | FA DCO | 5.8 percentage of participants |
Secondary
Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months
MRD\[-\] at 12-month was defined as achievement of MRD\[-\] status as assessed by next-generation sequencing (NGS; at a 10\^-5 level) at the 12 months landmark (from 8 months to 13 months window). 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method.
Time frame: 12 Months (8- to 13-month window)
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months | 5.2 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months | 18.3 percentage of participants |
Comparison: Odds ratios and corresponding 95% CIs were estimated by a stratified analysis using the Mantel-Haenszel method.95% CI: [2.007, 9.656]
Secondary
Percentage of Participants With a Complete Response (CR) as Assessed by the Independent Review Committee (PA DCO Only)
The percentage of participants in each treatment group who achieved stringent complete response (sCR) or CR per IMWG-URC, as assessed by the IRC, as their best response is presented.
Time frame: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Percentage of Participants With a Complete Response (CR) as Assessed by the Independent Review Committee (PA DCO Only) | 10.4 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Percentage of Participants With a Complete Response (CR) as Assessed by the Independent Review Committee (PA DCO Only) | 28.5 percentage of participants |
Secondary
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. QLQ-C30 questionnaire was administered prior to dosing every 28 ± 7 days starting from cycle 1 day 1 through first follow-up visit (30 days \[+3\] after last dose of all study drugs).
Time frame: Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO)
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 7 | 69.33 score on a scale | Standard Deviation 14.68 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 28 | 63.22 score on a scale | Standard Deviation 19.61 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 15 | 69.34 score on a scale | Standard Deviation 15.31 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 29 | 66.67 score on a scale | Standard Deviation 19.25 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 4 | 66.67 score on a scale | Standard Deviation 15.01 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 30 | 67.01 score on a scale | Standard Deviation 17.63 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 16 | 68.21 score on a scale | Standard Deviation 16.44 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 31 | 68.06 score on a scale | Standard Deviation 16.24 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 8 | 69.44 score on a scale | Standard Deviation 17.82 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 32 | 66.67 score on a scale | Standard Deviation 19.62 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 17 | 69.44 score on a scale | Standard Deviation 14.92 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 33 | 67.75 score on a scale | Standard Deviation 15.35 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Baseline | 66.19 score on a scale | Standard Deviation 19.19 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 34 | 68.18 score on a scale | Standard Deviation 15.78 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 18 | 66.67 score on a scale | Standard Deviation 16.5 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 35 | 65.91 score on a scale | Standard Deviation 15.62 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 36 | 63.77 score on a scale | Standard Deviation 18.22 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 5 | 67.62 score on a scale | Standard Deviation 17.19 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 37 | 67.50 score on a scale | Standard Deviation 18.91 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 19 | 69.68 score on a scale | Standard Deviation 17.5 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 38 | 65.20 score on a scale | Standard Deviation 18.69 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 10 | 68.38 score on a scale | Standard Deviation 14.56 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 39 | 64.71 score on a scale | Standard Deviation 15.46 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 20 | 71.04 score on a scale | Standard Deviation 14.49 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 40 | 58.33 score on a scale | Standard Deviation 14.25 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 11 | 67.42 score on a scale | Standard Deviation 15.24 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 41 | 66.07 score on a scale | Standard Deviation 13.26 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 21 | 70.94 score on a scale | Standard Deviation 15.87 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 42 | 63.69 score on a scale | Standard Deviation 15.19 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 3 | 66.13 score on a scale | Standard Deviation 18.12 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 43 | 67.22 score on a scale | Standard Deviation 15.89 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 22 | 68.52 score on a scale | Standard Deviation 12.3 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 44 | 61.81 score on a scale | Standard Deviation 15.27 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 12 | 65.13 score on a scale | Standard Deviation 14.94 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 45 | 67.59 score on a scale | Standard Deviation 12.11 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 23 | 69.52 score on a scale | Standard Deviation 16.41 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 46 | 64.58 score on a scale | Standard Deviation 13.91 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 6 | 68.06 score on a scale | Standard Deviation 15.8 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 47 | 66.67 score on a scale | Standard Deviation 0 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 24 | 68.10 score on a scale | Standard Deviation 18.24 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 48 | 61.11 score on a scale | Standard Deviation 9.62 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 13 | 67.49 score on a scale | Standard Deviation 16.51 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 49 | 61.11 score on a scale | Standard Deviation 9.62 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 25 | 67.93 score on a scale | Standard Deviation 16.15 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 50 | 61.11 score on a scale | Standard Deviation 9.62 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 2 | 64.35 score on a scale | Standard Deviation 16.25 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 51 | 63.89 score on a scale | Standard Deviation 4.81 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 26 | 70.71 score on a scale | Standard Deviation 18.65 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 52 | 54.17 score on a scale | Standard Deviation 17.68 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 14 | 67.66 score on a scale | Standard Deviation 17.03 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 27 | 65.23 score on a scale | Standard Deviation 14.78 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Follow-up | 61.00 score on a scale | Standard Deviation 23.04 |
| Kd - Carfilzomib and Dexamethasone | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 9 | 65.72 score on a scale | Standard Deviation 15.9 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 53 | 61.11 score on a scale | Standard Deviation 9.62 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Follow-up | 59.90 score on a scale | Standard Deviation 18.02 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 10 | 67.98 score on a scale | Standard Deviation 16.26 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 35 | 69.51 score on a scale | Standard Deviation 18 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Baseline | 61.79 score on a scale | Standard Deviation 20.37 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 2 | 61.00 score on a scale | Standard Deviation 19.65 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 3 | 63.10 score on a scale | Standard Deviation 18.24 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 4 | 63.47 score on a scale | Standard Deviation 18.66 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 5 | 64.45 score on a scale | Standard Deviation 16.76 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 6 | 65.92 score on a scale | Standard Deviation 16.85 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 7 | 65.73 score on a scale | Standard Deviation 16.59 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 8 | 66.34 score on a scale | Standard Deviation 16.64 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 9 | 67.82 score on a scale | Standard Deviation 15.53 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 11 | 68.52 score on a scale | Standard Deviation 17.37 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 12 | 67.47 score on a scale | Standard Deviation 17.16 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 13 | 67.00 score on a scale | Standard Deviation 18.21 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 14 | 66.12 score on a scale | Standard Deviation 16.6 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 15 | 67.61 score on a scale | Standard Deviation 17.68 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 16 | 66.41 score on a scale | Standard Deviation 18.69 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 17 | 69.81 score on a scale | Standard Deviation 15.28 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 18 | 66.29 score on a scale | Standard Deviation 16.38 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 19 | 68.00 score on a scale | Standard Deviation 17.33 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 20 | 66.43 score on a scale | Standard Deviation 19.52 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 21 | 67.42 score on a scale | Standard Deviation 16.25 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 22 | 67.51 score on a scale | Standard Deviation 17.9 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 23 | 66.67 score on a scale | Standard Deviation 17.63 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 24 | 68.00 score on a scale | Standard Deviation 16.51 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 25 | 66.21 score on a scale | Standard Deviation 16.78 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 26 | 66.12 score on a scale | Standard Deviation 17.54 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 27 | 66.52 score on a scale | Standard Deviation 18.35 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 28 | 67.28 score on a scale | Standard Deviation 18.66 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 29 | 67.22 score on a scale | Standard Deviation 18.1 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 30 | 67.23 score on a scale | Standard Deviation 18.52 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 31 | 67.33 score on a scale | Standard Deviation 18.81 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 32 | 67.91 score on a scale | Standard Deviation 18.45 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 33 | 67.95 score on a scale | Standard Deviation 18.92 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 34 | 69.86 score on a scale | Standard Deviation 17.77 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 36 | 68.22 score on a scale | Standard Deviation 16.93 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 37 | 68.63 score on a scale | Standard Deviation 19.01 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 38 | 69.25 score on a scale | Standard Deviation 18.47 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 39 | 68.38 score on a scale | Standard Deviation 19.15 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 40 | 67.74 score on a scale | Standard Deviation 19.34 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 41 | 68.46 score on a scale | Standard Deviation 19.37 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 42 | 67.16 score on a scale | Standard Deviation 18.77 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 43 | 63.30 score on a scale | Standard Deviation 19.91 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 44 | 65.50 score on a scale | Standard Deviation 18.21 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 45 | 66.87 score on a scale | Standard Deviation 15.53 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 46 | 67.89 score on a scale | Standard Deviation 17.66 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 47 | 68.52 score on a scale | Standard Deviation 13.74 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 48 | 68.56 score on a scale | Standard Deviation 13.35 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 49 | 68.42 score on a scale | Standard Deviation 13.49 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 50 | 68.75 score on a scale | Standard Deviation 13.09 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 51 | 67.36 score on a scale | Standard Deviation 11.49 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Cycle 52 | 62.04 score on a scale | Standard Deviation 17.24 |
Comparison: Analysis was performed based on a linear mixed effects model. The model included fixed effects of treatment (all baseline responses were modeled with a dummy treatment), baseline QLQ-C30 GHS/QoL score, randomization stratification factors (ISS stage at screening (Stage 1 or 2 vs Stage 3), prior proteasome inhibitor exposure (yes vs no), number of prior lines of therapy (1 vs ≥ 2)), interaction between treatment and time, and random effects of participant intercept and random slope of time.p-value: 0.94895% CI: [-2.52, 2.35]linear mixed effects model
Secondary
Time to Overall Response as Assessed by the Independent Review Committee (PA DCO Only)
Time to overall response was defined as the time from randomization to the earliest date a response of partial response (PR) or better as per IMWG-URC is first achieved and subsequently confirmed for participants with a best response of PR or better.
Time frame: From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks
Population: Participants who responded in the Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Time to Overall Response as Assessed by the Independent Review Committee (PA DCO Only) | 1.5 months | Standard Deviation 1.1 |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Time to Overall Response as Assessed by the Independent Review Committee (PA DCO Only) | 1.4 months | Standard Deviation 1.4 |
Secondary
Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only)
Time to progression was defined as the time (in months) from randomization to documented disease progression. This outcome reports TTP as the percentage of participants who were event free (that is, they had not had disease progression) at the specified time frames. Independent Review Committee assessment for this outcome measure was not planned after the primary analysis. 95% CIs for event-free rates were estimated using the method by Kalbfleisch and Prentice (1980) with log-log transformation.
Time frame: Randomization to Months 3, 6, 12, and 18
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | 3 months | 90.0 percentage of participants |
| Kd - Carfilzomib and Dexamethasone | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | 6 months | 79.4 percentage of participants |
| Kd - Carfilzomib and Dexamethasone | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | 12 months | 62.7 percentage of participants |
| Kd - Carfilzomib and Dexamethasone | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | 18 months | 45.1 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | 18 months | 68.5 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | 3 months | 95.3 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | 12 months | 77.5 percentage of participants |
| KdD - Carfilzomib, Dexamethasone and Daratumumab | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | 6 months | 86.4 percentage of participants |