Phase 3 Study For Relapsed/Refractory Myeloma Patients: Compares Daratumumab-Lenalidomide-Dex vs Lenalidomide-Dex

The Joan and Sanford I. Weill Department of Medicine of Weill Cornell Medical College and the NewYork-Presbyterian Hospital/Weill Cornell Medical Center announces a phase 3 study for relapsed/refractory myeloma patients. Sponsored by Janssen Research & Development, LLC, the trial for men and women with relapsed or refractory multiple myeloma comparing the drug combinations of Daratumumab-Lenalidomide-Dex versus Lenalidomide-Dex.

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

• 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 one 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

, RN lit2011@med.cornell.edu (212) 746-1480 Kathleen Pogonowski, RN kap9111@med.cornell.edu 212-746-6738

Disease Status and/or Stage

Relapsed or refractory (not responding to previous treatment) multiple myeloma

Sponsor

Janssen Research & Development, LLC

Principal Investigator

Protocol ID

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