Lenalidomide, Bortezomib and Dexamethasone vs High-Dose Treatment with Peripheral Stem Cell Transplant in Myeloma Patients Up to Age 65

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women, age 18 to 65, with newly diagnosed with multiple myeloma.

The study is evaluating the combination of three drugs, lenalidomide, bortezomib and dexamethasone, with or without autologous stem cell transplantation, as a potential treatment for newly diagnosed myeloma.

Bortezomib (also called Velcade) is FDA-approved to treat multiple myeloma. Lenalidomide (also called Revlimid) is approved for use with dexamethasone for people with multiple myeloma who have received prior therapy. However, the combination of these drugs has not been FDA-approved for treating newly diagnosed myeloma and is therefore considered experimental.

All study participants will receive one cycle of lenalidomide, bortezomib and dexamethasone treatment before being randomly assigned to one of two study arms:

  • Arm A: will receive two additional cycles of lenalidomide, bortezomib and dexamethasone prior to stem cell collection. After stem cell collection, will receive five cycles lenalidomide, bortezomib and dexamethasone. Participants in Arm A will then receive 12 months of lenalidomide treatment.
  • Arm B: will receive two additional cycles of lenalidomide, bortezomib and dexamethasone prior to stem cell collection. Participants in Arm B will then undergo autologous stem cell transplantation, followed by two cycles of lenalidomide, bortezomib and dexamethasone. Participants in Arm B will then receive 12 months of lenalidomide treatment.

Study participants will be followed for 3-6 years after receiving their final dose of study drug.  

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Disease Status and/or Stage

Untreated Multiple Myeloma

Sponsor

Dana Farber Cancer Institute

Key Eligibility

  • Age 18 to 65
  • Diagnosed with multiple myeloma
  • No prior systemic therapy
  • 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:

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

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