A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma

Study Status

Closed to Enrollment

Study Description

The purpose of this study is to evaluate the safety and effectiveness of a new experimental drug called carfilzomib, in combination with the drugs lenalidomide and dexamethasone in patients with relapsed multiple myeloma.

Carfilzomib is a type of drug called a proteasome inhibitor. Proteasome inhibitors work by inhibiting proteins (known as proteasomes) that cells need to survive and multiply. Cancer cells are more susceptible to this effect than normal cells. Inhibiting these proteins (proteasomes) may help kill cancer cells. There is evidence from a previous clinical trial with another proteasome inhibitor that combining the proteasome inhibitor with lenalidominde and dexamethasone may increase the activity of the drug regimen.

Patients will be randomly assigned to one of two study arms:

Arm 1:
  • Carfilzomib, lenalidomide and dexamethasome. Study drug will be administered in 28-day cycles, with the fourth week as a rest week. Cycles will be repeated for as long as you continue to do well on the study drug, up to 12 cycles. After receiving 12 cycles of study drug, you will continue to receive up to 6 additional cycles of lenalidomide, dexamethasone, and less frequent doses of carfilzomib.

Arm 2:

  • Lenalidomide and dexamethasone. Drugs will be administered in 28-day cycles, with the fourth week as a rest week. Cycles will be repeated for as long as you continue to do well on the drugs and do not have worsening of your disease.

Sponsor

Onyx Therapeutics

Key Eligibility

  • Men and women age 18 and older
  • Multiple myeloma, relapsed or progressive disease on or after any regimen
  • Prior treatment with at least one, but no more than three, regimens for multiple myeloma
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ruben Niesvizky, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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