Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

107

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline

Completed

Started Apr 2015

Typical duration for phase_1 multiple-myeloma

Geographic Reach

1 country

59 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.5 years study duration

First Submitted

Initial submission to the registry

December 23, 2014

Completed

20 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

April 30, 2015

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2019

Completed

1 year until next milestone

Results Posted

Study results publicly available

November 6, 2020

Completed

Last Updated

November 6, 2020

Status Verified

September 1, 2020

Enrollment Period

4.5 years

First QC Date

December 23, 2014

Results QC Date

October 15, 2020

Last Update Submit

October 15, 2020

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (6)

Number of Participants With Adverse Events (AEs)
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 important serious event The severity of each AE was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
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.
Change From Baseline in Hemoglobin Levels
Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Change From Baseline in Platelet Count
Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Change From Baseline in Neutrophil Count
Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15
Change From Baseline in Bilirubin
Baseline and Cycle 2 day 1
Change From Baseline in Creatinine
Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15

Secondary Outcomes (7)

Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
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
Time to Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
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
Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
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
Overall Response Rate (ORR)
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)
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.
+2 more secondary outcomes

Study Arms (6)

RRMM Dose-evaluation: Carfilzomib 56 mg/m²

EXPERIMENTAL

Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death. Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.