A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; BB 1101; Daratumumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

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

• If a participant has received subsequent anticancer therapy (salvage therapy), the participant must have a "wash-out period" defined as 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the planned start date of daratumumab monotherapy. The only exception is the emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day for a maximum of 4 days) before Daratumumab monotherapy

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 first dose of daratumumab monotherapy (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)