Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed or Refractory Multiple Myeloma

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with relapsed or refractory multiple myeloma.

Currently available treatments are effective in some patients but many experience side effects. Therefore, there is a need to find more effective treatments with fewer side effects. Daratumumab is a CD38 monoclonal human antibody. An antibody is something that finds and kills foreign objects in your body, in this case myeloma cells.  This antibody, daratumumab, recognizes a specific protein, CD38, which is often found on multiple myeloma cells. It is possible that the combination of Daratumumab, Lenalidomide, and Dexamethasone will be more effective than Lenalidomide combined with dexamethasone.

There are two treatment groups in this study as described below. Not everyone in the study will get daratumumab. The study medication will be given in treatment cycles, and each cycle is 28 days long.

Group 1:  This group will receive Daratumumab plus lenalidomide and dexamethasone

  • Daratumumab: given according to the following schedule:
  • Cycles 1 and 2: given every week 
  • Cycle 3 to 6: given every other week
  • Cycles 7 and beyond: given every 4 weeks
  • Lenalidomide: taken on Days 1 through 21 (no lenalidomide is taken the last week of each month)
  • Dexamethasone: taken every week

Group 2: This group will receive Lenalidomide and dexamethasone

  • Lenalidomide: taken on Days 1 through 21 (no lenalidomide is taken the last week of each month)
  • Dexamethasone: taken every week

Subjects will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Key eligibility:

  • Men and women age 18 and older
  • Diagnosis of relapsed or refractory multiple myeloma
  • Subject must have received at least 1 prior line of therapy for multiple myeloma and must have achieved a response (partial response or better)
  • Detailed eligibility reviewed when you contact the study team

Study Contact:
For more information
Linda Tegnestam, RN
(212) 746-1480

Kathleen Pogonowski, RN

Disease Status and/or Stage

Relapsed or Refractory (not responding to previous treatment) Multiple Myeloma


Janssen Research & Development, LLC

Principal Investigator

Ruben Niesvizky, M.D.

Protocol ID

WCMC IRB #1407015265; Sponsor Protocol #54767414MMY3003

Healthy Volunteers


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Contact Us

For general inquiries please e-mail:
Erica Bersin
Manager, Subject Recruitment & Communications
(646) 962-8232

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