Trial Outcomes & Findings for Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma (NCT NCT03934684)

Last Updated: 2026-05-11

Results Overview

A TEAE was any untoward medical occurrence in a clinical trial participant after the first dose of investigational product (IP) irrespective of a causal relationship with the IP. TEAEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03. Any clinically significant laboratory changes over time were recorded as TEAEs.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

101 participants

Primary outcome timeframe

From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months

Results posted on

2026-05-11

Participant Flow

101 participants were enrolled at 15 centers in India between September 2019 and June 2025.

Screening assessments were conducted within 28 days before enrollment into the trial.

Participant milestones

Participant milestones
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Overall Study STARTED	49	52
Overall Study COMPLETED	17	4
Overall Study NOT COMPLETED	32	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Overall Study Withdrawal by Subject	7	8
Overall Study Lost to Follow-up	2	5
Overall Study Death	2	2
Overall Study Discontinuation of carfilzomib	21	33

Baseline Characteristics

Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.	Total n=101 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 8.2 • n=44 Participants	61.9 years STANDARD_DEVIATION 9.9 • n=10 Participants	59.6 years STANDARD_DEVIATION 9.3 • n=30 Participants
Sex: Female, Male Female	17 Participants n=44 Participants	15 Participants n=10 Participants	32 Participants n=30 Participants
Sex: Female, Male Male	32 Participants n=44 Participants	37 Participants n=10 Participants	69 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=44 Participants	52 Participants n=10 Participants	101 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	49 Participants n=44 Participants	52 Participants n=10 Participants	101 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) White	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=44 Participants	0 Participants n=10 Participants	0 Participants n=30 Participants

PRIMARY outcome

Timeframe: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months

Population: Safety analysis set included all enrolled participants who received at least one dose of IP.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	46 Participants	45 Participants

PRIMARY outcome

Timeframe: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months

Population: Safety analysis set included all enrolled participants who received at least one dose of IP.

A serious TEAE was any untoward medical occurrence in a clinical trial participant after first dose of IP irrespective of a causal relationship with the IP(s), that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Number of Participants Who Experienced Serious TEAEs	11 Participants	20 Participants

SECONDARY outcome

Timeframe: From enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months

Population: Safety analysis set included all enrolled participants who received at least one dose of IP.

PFS was defined as the time from first dose of IP until the earliest date of disease progression (PD) or death due to any cause. PD was per IMWG-URC, with progression assessments at intervals as per local standard of care. PD: increase of 25% from lowest response value in serum M-component and/or urine M-component and/or only in participants without measurable serum and urine M protein levels: the difference between involved and uninvolved free light chain (FLC) levels and/or only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow (BM) plasma cell percentage; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia. Medians were estimated using the Kaplan-Meier method. Corresponding 95% confidence intervals (CIs) were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Progression Free Survival (PFS) as Per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC)	NA months Interval 14.7 to Median and upper bound of the CI was not estimable for group due to low number of PFS events observed by the analysis time.	NA months Interval 13.1 to Median and upper bound of the CI was not estimable for group due to low number of PFS events observed by the analysis time.

SECONDARY outcome

Timeframe: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months

Population: Safety analysis set included all enrolled participants who received at least one dose of IP.

ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \< 200 mg/24-hours. The ORR 95% CIs were estimated using the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Overall Response Rate (ORR) as Per IMWG-URC	59.2 percentage of participants Interval 44.2 to 73.0	53.8 percentage of participants Interval 39.5 to 67.8

SECONDARY outcome

Timeframe: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months

Population: Safety analysis set included all enrolled participants who received at least one dose of IP.

CBR was defined as the percentage of participants with either the best overall response of sCR, CR, VGPR, PR, and minimal response (MR) as determined by the IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in BM. sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \< 200 mg/24-hours. MR: ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50% to 89%. The CBR 95% CIs were estimated using the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Clinical Benefit Rate (CBR) as Per IMWG-URC	63.3 percentage of participants Interval 48.3 to 76.6	57.7 percentage of participants Interval 43.2 to 71.3

SECONDARY outcome

Timeframe: From the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months

Population: Safety analysis set included all enrolled participants who received at least one dose of IP. TTR was calculated only for participants who achieved a best overall response of PR or better.

TTR was defined as the time from first dose date to the earliest date when confirmed sCR, CR, VGPR, or PR was first achieved. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in BM. sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to \< 200 mg/24-hours. Medians were estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=29 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=28 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Time to Response (TTR) as Per IMWG-URC	2.8 months Interval 1.0 to 10.0	2.6 months Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: From enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months

Population: Safety analysis set included all enrolled participants who received at least one dose of IP. DOR was calculated only for participants who achieved a best overall response of PR or better.

DOR was defined as the time from first evidence of PR or better as per IMWG-URC to the earliest of PD or death due to any cause for participants with a best response of PR or better. PD: increase of 25% from lowest response value in serum M-component and/or urine M-component and/or only in participants without measurable serum and urine M protein levels: the difference between involved and uninvolved FLC levels and/or only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell percentage; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia. Medians were estimated using the Kaplan-Meier method. Corresponding 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.

Outcome measures

Outcome measures
Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=29 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=28 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or IV infusion on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Duration of Response (DOR) as Per IMWG-URC	NA months Interval 11.9 to Median and upper bound of the CI was not estimable for group due to low number of PFS events observed by the analysis time.	NA months Interval 12.4 to Median and upper bound of the CI was not estimable for group due to low number of PFS events observed by the analysis time.

Adverse Events

Carfilzomib, Lenalidomide and Dexamethasone (KRd)

Serious events: 11 serious events

Other events: 45 other events

Deaths: 2 deaths

Carfilzomib and Dexamethasone (Kd)

Serious events: 20 serious events

Other events: 42 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER