Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments daratumumab, lenalidomide, dexamethasone
Phase phase 3
Targets CD-38, CD38
Sponsor Janssen Research & Development, LLC
Start date May 2014
End date March 2016
Trial size 569 participants
Trial identifier NCT02076009, 2013-005525-23, 54767414MMY3003, CR103663

Summary

The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
During each 28-day treatment cycle, participants will receive daratumumab, lenalidomide, and dexamethasone.
daratumumab
Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; once only (on Day 1) during treatment cycles 7 onwards.
lenalidomide
Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.
dexamethasone
Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
(Active Comparator)
During each 28-day treatment cycle, participants will receive lenalidomide and dexamethasone.
lenalidomide
Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle.
dexamethasone
Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
(Active Comparator)
During each 28-day treatment cycle, participants will receive daratumumab alone in daratumumab monotherapy group.
daratumumab
Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; once only (on Day 1) during treatment cycles 7 onwards.

Primary Outcomes

Measure
Progression-free survival (PFS)
time frame: From randomization to either disease progression or death whichever occurs first until 3 years

Secondary Outcomes

Measure
Time to Progression of Disease
time frame: From randomization to either disease progression or death whichever occurs first until 3 years
Overall response rate
time frame: From randomization until 3 years
Number of participants who achieve very good partial response (VGPR) or better
time frame: From randomization up to 3 years
Time to complete response (CR) or partial response (PR)
time frame: From randomization up to first documented CR or PR until 3 years
Overall survival
time frame: Up to approximately 5 years (anticipated) after the last participant is randomized
Duration of response
time frame: From randomization to the date of first documented evidence of PD until 3 years
Percentage of Participants With Minimal residual disease (MRD)
time frame: From randomization to the date of first documented evidence of CR and Month 3 and 6 post CR

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Must have documented multiple myeloma and measurable disease - Must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen - Must have documented evidence of progressive disease as defined by the International Myeloma Working Group criteria on or after their last regimen - Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2 Exclusion Criteria: - Has received any of the following therapies: daratumumab or other anti-CD38 therapies - Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment - Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment - Has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease - History of malignancy (other than multiple myeloma) within 5 years before the date of randomization

Additional Information

Official title Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
Description This is a randomized (participants will be assigned by chance to study treatments), open-label (all participants and study personnel will know the identity of the study treatments), active-controlled (none of the study treatments are placebo), parallel-group (both treatment arms will run at the same time), multicenter study. In this study, daratumumab, lenalidomide, and low-dose dexamethasone (DRd) will be compared with lenalidomide and low dose dexamethasone (Rd) in participants with relapsed or refractory multiple myeloma. Participants will be randomized in a 1:1 ratio to receive either DRd or Rd. The study will include a Screening Phase, a Treatment Phase (involving treatment cycles of approximately 28 days in length), and a Follow-up Phase. The Treatment Phase will extend from the administration of the first dose of study medication until disease progression or unacceptable toxicity. Participants will also discontinue study treatment if: they become pregnant; have their dose held for more than 28 days (or if 3 consecutive planned doses of daratumumab are missed for reasons other than toxicity); or for safety reasons (for example, adverse event). The Follow-up Phase will begin at the end of treatment and will continue until death, loss to follow-up, consent withdrawal for study participation, or study end, whichever occurs first. Eligible participants from Rd group who have had sponsor-confirmed disease progression will be offered the option for treatment with daratumumab monotherapy (of 28 days cycle). The primary endpoint will be progression-free survival (PFS). Analysis of the primary endpoint is anticipated to be performed at approximately 18 months after the last subject is randomized. Study end is anticipated at approximately 5 years after the last subject is randomized. Blood and urine samples will be obtained at time points during the study, together with bone marrow aspirates/biopsies and skeletal surveys. Participant safety will be assessed throughout the study.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.