NCT02335983 is a Phase 1 clinical trial of Carfilzomib in Multiple Myeloma, sponsored by Amgen.

Who is sponsoring NCT02335983?

NCT02335983 is sponsored by Amgen.

What drugs are being tested in NCT02335983?

Interventions in NCT02335983: Carfilzomib, Lenalidomide, Dexamethasone.

What condition does NCT02335983 study?

NCT02335983 studies Multiple Myeloma.

Is NCT02335983 still recruiting?

NCT02335983 is currently completed. Last updated 6 November 2020.

Are results published for NCT02335983?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-06 · How we verify

NCT02335983

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma

Completed Phase 1 Results posted Last updated 6 November 2020

What this trial tests

Phase 1 trial testing Carfilzomib in Multiple Myeloma in 107 participants. Completed in 28 October 2019.

Timeline

30 April 2015

Primary endpoint
28 October 2019

28 October 2019

Quick facts

Lead sponsor	Amgen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	107
Start date	30 April 2015
Primary completion	28 October 2019
Estimated completion	28 October 2019
Sites	59 locations across United States

Drugs / interventions tested

Carfilzomib (carfilzomib) — full drug profile →
Lenalidomide — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Amgen — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs) Primary · From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.

Safety and tolerability were evaluated according to the type, incidence, and severity of adverse events. An AE is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: * fatal * life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically importan

Any adverse event (AE)

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	10
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	12
RRMM Dose-expansion: Carfilzomib 70 mg/m²	34
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	9
NDMM Dose-expansion: Carfilzomib 70 mg/m²	9
NDMM Dose-expansion: Carfilzomib 56 mg/m²	33

AE Grade ≥ 3

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	7
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	9
RRMM Dose-expansion: Carfilzomib 70 mg/m²	23
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	5
NDMM Dose-expansion: Carfilzomib 70 mg/m²	6
NDMM Dose-expansion: Carfilzomib 56 mg/m²	21

Serious adverse events

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	4
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	5
RRMM Dose-expansion: Carfilzomib 70 mg/m²	10
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	3
NDMM Dose-expansion: Carfilzomib 70 mg/m²	3
NDMM Dose-expansion: Carfilzomib 56 mg/m²	11

AEs leading to discontinuation of carfilzomib

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	1
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	2
RRMM Dose-expansion: Carfilzomib 70 mg/m²	5
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0
NDMM Dose-expansion: Carfilzomib 70 mg/m²	2
NDMM Dose-expansion: Carfilzomib 56 mg/m²	1

AEs leading to discontinuation of lenalidomide

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	1
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	2
RRMM Dose-expansion: Carfilzomib 70 mg/m²	5
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0
NDMM Dose-expansion: Carfilzomib 70 mg/m²	2
NDMM Dose-expansion: Carfilzomib 56 mg/m²	2

AEs leading to discontinuation of dexamethasone

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	1
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	2
RRMM Dose-expansion: Carfilzomib 70 mg/m²	5
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0
NDMM Dose-expansion: Carfilzomib 70 mg/m²	2
NDMM Dose-expansion: Carfilzomib 56 mg/m²	2

Fatal adverse events

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	0
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	0
RRMM Dose-expansion: Carfilzomib 70 mg/m²	2
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0
NDMM Dose-expansion: Carfilzomib 70 mg/m²	0
NDMM Dose-expansion: Carfilzomib 56 mg/m²	0

Treatment-related adverse events (TRAE)

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	9
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	11
RRMM Dose-expansion: Carfilzomib 70 mg/m²	30
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	9
NDMM Dose-expansion: Carfilzomib 70 mg/m²	9
NDMM Dose-expansion: Carfilzomib 56 mg/m²	32

Change From Baseline in Hemoglobin Levels Primary · Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15

Baseline

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	116.90	± 14.58
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	120.67	± 13.51
RRMM Dose-expansion: Carfilzomib 70 mg/m²	123.24	± 16.57
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	111.50	± 18.04
NDMM Dose-expansion: Carfilzomib 70 mg/m²	120.00	± 20.96
NDMM Dose-expansion: Carfilzomib 56 mg/m²	113.21	± 16.66

Change from Baseline to Cycle 1 Day 8

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-1.50	± 7.52
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-3.33	± 6.39
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-0.91	± 5.46
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-1.25	± 8.17
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-5.56	± 6.11
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-1.82	± 7.21

Change from Baseline to Cycle 1 Day 15

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-6.90	± 8.61
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-9.50	± 6.29
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-5.10	± 7.88
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-1.75	± 12.70
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-6.50	± 10.20
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-5.64	± 9.10

Change from Baseline to Cycle 2 Day 1

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-5.70	± 9.78
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-9.25	± 8.67
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-7.38	± 7.76
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-3.75	± 12.65
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-3.29	± 9.60
NDMM Dose-expansion: Carfilzomib 56 mg/m²	2.19	± 10.59

Change from Baseline to Cycle 2 Day 8

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-6.00	± 11.91
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-8.17	± 9.00
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-5.59	± 8.35
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-0.13	± 14.64
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-2.86	± 8.49
NDMM Dose-expansion: Carfilzomib 56 mg/m²	4.19	± 12.41

Change from Baseline to Cycle 2 Day 15

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-8.50	± 12.47
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-11.33	± 8.04
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-8.45	± 10.08
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0.00	± 14.05
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-5.14	± 13.58
NDMM Dose-expansion: Carfilzomib 56 mg/m²	2.97	± 13.04

Change From Baseline in Platelet Count Primary · Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15

Baseline

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	151.60	± 54.40
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	202.50	± 67.13
RRMM Dose-expansion: Carfilzomib 70 mg/m²	172.38	± 33.70
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	214.00	± 79.22
NDMM Dose-expansion: Carfilzomib 70 mg/m²	242.89	± 99.24
NDMM Dose-expansion: Carfilzomib 56 mg/m²	233.03	± 67.76

Change from Baseline to Cycle 1 Day 8

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-12.90	± 29.88
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-49.50	± 58.90
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-17.36	± 21.75
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	2.38	± 63.66
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-51.11	± 42.10
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-21.42	± 36.40

Change from Baseline to Cycle 1 Day 15

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-58.60	± 32.76
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-66.83	± 87.14
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-66.39	± 38.30
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-23.25	± 116.67
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-101.88	± 84.66
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-53.39	± 43.60

Change from Baseline to Cycle 2 Day 1

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	55.00	± 38.61
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	68.67	± 84.62
RRMM Dose-expansion: Carfilzomib 70 mg/m²	44.84	± 52.82
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	141.75	± 92.68
NDMM Dose-expansion: Carfilzomib 70 mg/m²	152.00	± 244.50
NDMM Dose-expansion: Carfilzomib 56 mg/m²	111.06	± 84.26

Change from Baseline to Cycle 2 Day 8

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-44.10	± 38.14
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-74.75	± 86.91
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-71.06	± 37.93
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-28.00	± 111.10
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-106.29	± 130.18
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-52.78	± 60.70

Change from Baseline to Cycle 2 Day 15

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-44.40	± 21.48
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-63.25	± 72.53
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-60.13	± 43.37
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-21.25	± 82.11
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-76.14	± 116.02
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-44.19	± 64.73

Change From Baseline in Neutrophil Count Primary · Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15

Baseline

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	2.53	± 1.01
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	3.40	± 1.54
RRMM Dose-expansion: Carfilzomib 70 mg/m²	2.72	± 0.94
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	3.04	± 0.73
NDMM Dose-expansion: Carfilzomib 70 mg/m²	3.24	± 2.24
NDMM Dose-expansion: Carfilzomib 56 mg/m²	3.26	± 1.46

Change from Baseline to Cycle 1 Day 8

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	0.02	± 0.82
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	0.03	± 1.87
RRMM Dose-expansion: Carfilzomib 70 mg/m²	0.97	± 1.19
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0.59	± 1.20
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-0.19	± 1.25
NDMM Dose-expansion: Carfilzomib 56 mg/m²	0.37	± 1.29

Change from Baseline to Cycle 1 Day 15

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	0.28	± 1.14
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-0.09	± 1.94
RRMM Dose-expansion: Carfilzomib 70 mg/m²	0.81	± 1.09
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	1.08	± 1.53
NDMM Dose-expansion: Carfilzomib 70 mg/m²	0.43	± 1.83
NDMM Dose-expansion: Carfilzomib 56 mg/m²	0.09	± 1.48

Change from Baseline to Cycle 2 Day 1

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	0.36	± 1.99
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-0.33	± 1.59
RRMM Dose-expansion: Carfilzomib 70 mg/m²	0.16	± 1.15
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0.02	± 0.58
NDMM Dose-expansion: Carfilzomib 70 mg/m²	0.09	± 2.46
NDMM Dose-expansion: Carfilzomib 56 mg/m²	0.18	± 0.95

Change from Baseline to Cycle 2 Day 8

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	0.18	± 0.68
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-0.67	± 1.28
RRMM Dose-expansion: Carfilzomib 70 mg/m²	0.63	± 1.08
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0.57	± 1.05
NDMM Dose-expansion: Carfilzomib 70 mg/m²	0.46	± 2.49
NDMM Dose-expansion: Carfilzomib 56 mg/m²	0.41	± 1.25

Change from Baseline to Cycle 2 Day 15

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-0.30	± 0.71
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-0.54	± 1.69
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-0.06	± 1.25
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	0.33	± 0.53
NDMM Dose-expansion: Carfilzomib 70 mg/m²	0.56	± 2.92
NDMM Dose-expansion: Carfilzomib 56 mg/m²	0.42	± 2.00

Change From Baseline in Bilirubin Primary · Baseline and Cycle 2 day 1

Baseline

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	8.55	± 3.78
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	9.98	± 4.72
RRMM Dose-expansion: Carfilzomib 70 mg/m²	9.10	± 4.76
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	10.26	± 4.38
NDMM Dose-expansion: Carfilzomib 70 mg/m²	6.84	± 4.01
NDMM Dose-expansion: Carfilzomib 56 mg/m²	7.16	± 3.29

Change from Baseline to Cycle 2 Day 1

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	0.86	± 3.25
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	1.00	± 3.68
RRMM Dose-expansion: Carfilzomib 70 mg/m²	1.34	± 3.52
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	3.42	± 5.56
NDMM Dose-expansion: Carfilzomib 70 mg/m²	0.49	± 2.91
NDMM Dose-expansion: Carfilzomib 56 mg/m²	1.21	± 3.10

Change From Baseline in Creatinine Primary · Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15

Baseline

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	80.18	± 18.57
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	82.88	± 22.01
RRMM Dose-expansion: Carfilzomib 70 mg/m²	79.09	± 17.61
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	75.80	± 7.78
NDMM Dose-expansion: Carfilzomib 70 mg/m²	95.37	± 41.17
NDMM Dose-expansion: Carfilzomib 56 mg/m²	80.60	± 21.56

Change from Baseline to Cycle 1 Day 8

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-2.65	± 5.05
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-5.30	± 10.29
RRMM Dose-expansion: Carfilzomib 70 mg/m²	2.09	± 8.31
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-1.22	± 8.25
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-8.51	± 29.44
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-0.22	± 12.89

Change from Baseline to Cycle 1 Day 15

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-4.42	± 7.92
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-4.60	± 11.32
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-1.85	± 12.69
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	3.65	± 27.29
NDMM Dose-expansion: Carfilzomib 70 mg/m²	29.39	± 130.24
NDMM Dose-expansion: Carfilzomib 56 mg/m²	0.42	± 17.59

Change from Baseline to Cycle 2 Day 1

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-3.80	± 6.81
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-7.74	± 11.98
RRMM Dose-expansion: Carfilzomib 70 mg/m²	-1.44	± 9.66
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-10.39	± 10.05
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-17.17	± 36.71
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-4.31	± 9.84

Change from Baseline to Cycle 2 Day 8

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-6.45	± 4.97
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-11.09	± 12.70
RRMM Dose-expansion: Carfilzomib 70 mg/m²	1.85	± 10.95
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-12.27	± 8.20
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-20.08	± 37.86
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-4.32	± 9.36

Change from Baseline to Cycle 2 Day 15

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	-6.28	± 10.29
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	-13.26	± 9.05
RRMM Dose-expansion: Carfilzomib 70 mg/m²	4.88	± 13.78
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	-12.38	± 6.90
NDMM Dose-expansion: Carfilzomib 70 mg/m²	-21.85	± 39.17
NDMM Dose-expansion: Carfilzomib 56 mg/m²	-1.99	± 18.08

Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group Secondary · Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion

Group	Value	95% CI
Carfilzomib 56 mg/m²	11700	± 67300
Carfilzomib 70 mg/m²	12400	± 45000

Time to Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group Secondary · Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion

Group	Value	95% CI
Carfilzomib 56 mg/m²	0.28	0.17 – 24
Carfilzomib 70 mg/m²	0.27	0.17 – 0.68

Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group Secondary · Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion

Group	Value	95% CI
Carfilzomib 56 mg/m²	4150	± 17500
Carfilzomib 70 mg/m²	9130	± 32800

Overall Response Rate (ORR) Secondary · Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.

Response was determined by the investigator based on the International Myeloma Working Group Uniform Response Criteria (IMWG URC). ORR was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Responses must have been confirmed in 2 consecutive assessments at any time prior to initiation of any new therapy. Disease assessments included serum protein electrophoresis (SPEP) with immunofixation, urine protein electrophoresis (UPEP; 24-hour assessment) with im

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	90.0	55.5 – 99.7
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	91.7	61.5 – 99.8
RRMM Dose-expansion: Carfilzomib 70 mg/m²	88.2	72.5 – 96.7
RRMM: Combined Carfilzomib 70 mg/m²	89.1	76.4 – 96.4
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	88.9	51.8 – 99.7
NDMM Dose-expansion: Carfilzomib 70 mg/m²	77.8	40.0 – 97.2
NDMM: Combined Carfilzomib 70 mg/m²	83.3	58.6 – 96.4
NDMM Dose-expansion: Carfilzomib 56 mg/m²	97.0	84.2 – 99.9

Complete Response Rate (CRR) Secondary · Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.

Complete Response Rate (CRR) is defined as the percentage of participants who achieved a best overall response of either stringent complete response (sCR) or complete response (CR) in accordance with International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM) CR: Negative serum and urine immunofixation, disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in BM, and normal SFLC ratio in participants with measurable disease only by SFLC.

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	20.0	2.5 – 55.6
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	16.7	2.1 – 48.4
RRMM Dose-expansion: Carfilzomib 70 mg/m²	26.5	12.9 – 44.4
RRMM: Combined Carfilzomib 70 mg/m²	23.9	12.6 – 38.8
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	22.2	2.8 – 60.0
NDMM Dose-expansion: Carfilzomib 70 mg/m²	11.1	0.3 – 48.2
NDMM: Combined Carfilzomib 70 mg/m²	16.7	3.6 – 41.4
NDMM Dose-expansion: Carfilzomib 56 mg/m²	33.3	18.0 – 51.8

Progression-free Survival (PFS) Secondary · From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.

PFS is defined as the time from the first day of study treatment to the earlier of disease progression or death due to any cause. Disease progression was determined by the investigator according to IMWG-URC. Progressive Disease (PD): Increase of 25% from lowest value in serum M-component (absolute increase ≥ 0.5 g/dL), urine M-component (absolute increase ≥ 200 mg per 24 hours) and/or the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, and/or any new or increase in size of bone lesions or sof

Group	Value	95% CI
RRMM Dose-evaluation: Carfilzomib 56 mg/m²	NA	14.8 – NA
RRMM Dose-evaluation: Carfilzomib 70 mg/m²	NA	5.6 – NA
RRMM Dose-expansion: Carfilzomib 70 mg/m²	NA	21.1 – NA
RRMM: Combined Carfilzomib 70 mg/m²	NA	21.1 – NA
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²	NA	4.7 – NA
NDMM Dose-expansion: Carfilzomib 70 mg/m²	NA	NA – NA
NDMM: Combined Carfilzomib 70 mg/m²	NA	NA – NA
NDMM Dose-expansion: Carfilzomib 56 mg/m²	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RRMM Dose-evaluation: Carfilzomib 56 mg/m²

Serious: 4/10 (40%)

Deaths: 0/10

RRMM Dose-evaluation: Carfilzomib 70 mg/m²

Serious: 5/12 (42%)

Deaths: 0/12

RRMM Dose-expansion: Carfilzomib 70 mg/m²

Serious: 10/34 (29%)

Deaths: 2/34

NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²

Serious: 3/9 (33%)

Deaths: 0/9

NDMM Dose-expansion: Carfilzomib 70 mg/m²

Serious: 3/9 (33%)

Deaths: 0/9

NDMM Dose-expansion: Carfilzomib 56 mg/m²

Serious: 11/33 (33%)

Deaths: 0/33

Serious adverse events (44 terms)

Reaction	System	RRMM Dose-evaluation: Carf…	RRMM Dose-evaluation: Carf…	RRMM Dose-expansion: Carfi…	NDMM Dose-evaluation: Carf…	NDMM Dose-expansion: Carfi…	NDMM Dose-expansion: Carfi…
Pneumonia	Infections and infestations	—	—	—	—	—	—
Thrombotic microangiopathy	Blood and lymphatic system disorders	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—
Cardiac disorder	Cardiac disorders	—	—	—	—	—	—
Vitello-intestinal duct remnant	Congenital, familial and genetic disorders	—	—	—	—	—	—
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—
Peripheral swelling	General disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Strangulated hernia	General disorders	—	—	—	—	—	—
Systemic inflammatory response syndrome	General disorders	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—
Clostridium difficile colitis	Infections and infestations	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Orchitis	Infections and infestations	—	—	—	—	—	—
Pneumonia influenzal	Infections and infestations	—	—	—	—	—	—
Pneumonia respiratory syncytial viral	Infections and infestations	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—

Other adverse events (247 terms — click to expand)

Reaction	System	RRMM Dose-evaluation: Carf…	RRMM Dose-evaluation: Carf…	RRMM Dose-expansion: Carfi…	NDMM Dose-evaluation: Carf…	NDMM Dose-expansion: Carfi…	NDMM Dose-expansion: Carfi…
Fatigue	General disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Thrombotic microangiopathy, Cardiac failure congestive, Pleural effusion, Febrile neutropenia, Pancytopenia, Thrombocytopenia, Angina pectoris.

Data from ClinicalTrials.gov NCT02335983 adverse events section.

Sponsor's own description

The purpose of the study is to assess the safety, tolerability and activity of a once-weekly regimen of carfilzomib in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Weekly carfilzomib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma: A phase 1b study.
Biran N, Siegel D, Berdeja JG, Raje N, et al · · 2019 · cited 12× · PMID 31021005 · DOI 10.1002/ajh.25498
Phase 1b trial of proteasome inhibitor carfilzomib with irinotecan in lung cancer and other irinotecan-sensitive malignancies that have progressed on prior therapy (Onyx IST reference number: CAR-IST-553).
Arnold SM, Chansky K, Leggas M, Thompson MA, et al · · 2017 · cited 10× · PMID 28204981 · DOI 10.1007/s10637-017-0441-4
A phase 1b study of once-weekly carfilzomib combined with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma.
Alsina M, Landgren O, Raje N, Niesvizky R, et al · · 2021 · cited 3× · PMID 33125764 · DOI 10.1002/ajh.26041
Immunotherapy Strategies Against Multiple Myeloma
Ma J, Li Q, Yu Z, Cao Z, et al · · 2017

Verify or expand the search:

Other trials of Carfilzomib

Trials testing the same drug.

NCT07463807 — Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carf · Phase 1, PHASE2 · not yet recruiting
NCT06948084 — Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Darat · Phase 2 · not yet recruiting
NCT06918990 — Treatment of Antibody-Mediated Rejection (ABMR) With CarBel · Phase 2 · not yet recruiting
NCT07082270 — Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma · Phase 1 · withdrawn
NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi · Phase 3 · recruiting

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02335983 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 6 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02335983.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02335983

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (44 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Carfilzomib

Other recruiting trials for Multiple Myeloma

Other Amgen trials

Verify against primary sources