A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women who have been recently diagnosed with multiple myeloma and who have not received treatment for the myeloma.

The purpose of the study is to compare the effectiveness of combination therapy with Carfilzomib, melphalan and prednisone, versus the combination of Velcade (bortezomib), melphalan and prednisone (the approved therapy for newly diagnosed multiple myeloma).

Carfilzomib (also called Kyprolis) is FDA-approved for treating advanced myeloma that no longer responds to other therapies. It is not approved for treating newly diagnosed myeloma; therefore its use in this study is considered experimental.

Carfilzomib is a type of drug called a proteasome inhibitor. It works by preventing breakdown of abnormal proteins in cells, causing the cells to die. Cancer cells are more sensitive to these effects. Velcade, which is FDA-approved to treat newly diagnosed myeloma, is also a proteasome inhibitor. Melphalan is FDA-approved for treating myeloma, and it works by stopping or slowing the growth of cancer cells. Prednisone is a steroid and is also FDA-approved.

Study participants will be randomly assigned to one of two study arms. Participants in both arms will receive dexamethasone during the start of therapy. Treatment cycles are 6 weeks, with treatment during Weeks 1 and 2, Week 3 off, treatment during Weeks 4 and 5, then Week off.

Arm 1, Carfilzomib, melphalan, prednisone:
  • Carfilzomib via infusion on Days 1 and 2 of each treatment week
  • Melphalan and prednisone by mouth on first 4 days of treatment during Week 1 of each cycle

Arm 2, Velcade, melphalan, prednisone:

  • Velcade via infusion on Days 1 and 4 of each treatment week during Cycles 1 to 4
  • Velcade via infusion on Day 1 of each treatment week Cycles 5 to 9
  • Melphalan and prednisone by mouth on first 4 days of treatment during Week 1 of each cycle
Participants will receive up to 9 treatment cycles as long as they are responding to therapy and not experiencing unacceptable side effects.
Key eligibility:
  • Men and women age 18 and older
  • Newly diagnosed with multiple myeloma
  • Not eligible for transplant
  • No prior treatment for multiple myeloma
  • Detailed eligibility reviewed when you contact the study team

Study contacts:
Linda Tegnestam, RN
Email: lit2011@med.cornell.edu
Phone: (212) 746-1480

Kathleen Pogonowski, RN
Email: kap9111@med.cornell.edu
Phone: (212) 746-6738

Disease Status and/or Stage

Newly Diagnosed Multiple Myeloma

Sponsor

Onyx Pharmaceuticals

Principal Investigator

Ruben Niesvizky, M.D.


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Contact Us

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

Erica Bersin
Tel: (646) 962-8232
erb3001@med.cornell.edu

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