A Phase IB Study of SAR650984 with Lenalidomide and Dexamethasone to Treat Recurrent or Persistent Multiple Myeloma

Protocol
13-006
Full Title
A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Phase
I
Purpose

The purpose of this study is to find the highest dose of an investigational drug called SAR650984 that can be given safely in combination with lenalidomide and dexamethasone in patients with multiple myeloma that is not responding to standard therapy or has returned after therapy. SAR650984 is designed to stop the growth of some blood cancers (such as multiple myeloma) by attaching to a protein called CD38.

Lenalidomide and dexamethasone are both used in the standard treatment of multiple myeloma. Researchers will also observe the preliminary effectiveness of combining these drugs with SAR650984 in patients with multiple myeloma. SAR650984 is given intravenously (by vein), while lenalidomide and dexamethasone are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have multiple myeloma that has stopped responding to or has returned after at least two regimens of previous therapy.
  • At least 3 weeks must have passed since completion of prior therapy and entry into the study.
  • At least 12 weeks must have passed since a peripheral stem cell transplant and receipt of the study drug.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Nikoletta Lendvai at 212-639-3368.

Disease(s)
Hematology: Multiple Myeloma
Locations
Related Diseases