A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone Versus Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
Open to Enrollment
This clinical trial is for men and women with multiple myeloma who have had 1 to 3 prior therapies for myeloma and who have progressed, or relapsed, following one of their treatments.
The purpose of the study is to compare the effectiveness of the combination of the experimental drug carfilzomib and dexamethasone, versus the combination of bortezomib (also called Velcade) and dexamethasone in treating relapsed multiple myeloma.
Carfilzomib and bortezomib are both a type of drug called a proteasome inhibitor. They work by preventing the breakdown of abnormal proteins in cells, causing the cells the die. Cancer cells are more sensitive to these effects than normal cells. Bortezomib is FDA-approved to treat multiple myeloma. Dexamethasone is a steroid and is also FDA-approved.
Study participants will be randomly assigned to one of two study arms:
- Arm 1, Carfilzomib + Dexamethasone: Each dosing cycle is 28 days; participants will receive carfilzomib via infusion 2 times per week for 3 out of 4 weeks of each cycle, and dexamethasone 2 times per week for 4 weeks of each cycle
- Arm 2, Bortezomib (Velcade) + Dexamethasone: Each dosing cycle is 21 days; participants will receive bortezomib via injection 2 times per week for 2 out of 3 weeks of each cycle, and dexamethasone 4 times per week for 2 out of 3 weeks of each cycle
Participants may continue to receive the study therapies as long as they continue to respond to and are able to tolerate the treatment.
Follow the Myeloma Center online:
Disease Status and/or Stage
Relapsed Multiple Myeloma
- Men and women age 18 and older
- Diagnosed with multiple myeloma
- Have received at least 1 and no more than 3 treatment regimens or lines of therapy for multiple myeloma
- Detailed eligibility reviewed when you contact the study team
- The Myeloma Center
- (212) 746-3964
As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.
For general inquiries, or if you need assistance finding a study, please contact:
Subject Recruitment Manager
Tel: (646) 962-9340