Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65

• Status: Active, not recruiting
• Trial end date: 2023-09-01

Summary

The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have not been approved in the combination for multiple myeloma or any other type of cancer. Bortezomib is currently approved by the FDA for the treatment of multiple myeloma. Lenalidomide is approved for use with dexamethasone for patients with multiple myeloma who have received at least one prior therapy and for the treatment of certain types of myelodysplastic syndrome (another type of cancer affecting the blood). Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Please note that Bortezomib and Lenalidomide are provided to patients participating in this trial at no charge. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as a high-dose conditioning treatment prior to stem cell transplantation. Cyclophosphamide is used, either alone, or in combination with other drugs, to treat multiple myeloma. These drugs have been used in other multiple myeloma studies and information from those studies suggests that this combination of therapy may help to treat newly diagnosed multiple myeloma.

In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.

• Phase: Phase 3

Details

• Lead Sponsor: Paul G. Richardson, MD
• Collaborators: Barbara Ann Karmanos Cancer Institute; Baylor College of Medicine; Beckman Research Institute; Beth Israel Deaconess Medical Center; Cape Cod Healthcare; Cape Cod Hospital; Celgene Corporation; City of Hope Medical Center; Columbia University; Duke University; Eastern Maine Medical Center; Emory University; Fox Chase Cancer Center; Fred Hutchinson Cancer Research Center; H. Lee Moffitt Cancer Center and Research Institute; Huntsman Cancer Institute; Icahn School of Medicine at Mount Sinai; M.D. Anderson Cancer Center; Massachusetts General Hospital; Memorial Sloan Kettering Cancer Center; Millennium Pharmaceuticals, Inc.; Newton-Wellesley Hospital; Northwell Health; Ochsner Health System; Ohio State University; OHSU Knight Cancer Institute; Roswell Park Cancer Institute; Stanford University; State University of New York - Downstate Medical Center; UNC Lineberger Comprehensive Cancer Center; University of Alabama at Birmingham; University of Arizona; University of California, San Diego; University of California, San Francisco; University of Chicago; University of Florida; University of Michigan; University of Mississippi Medical Center; University of Pittsburgh; University of Pittsburgh Medical Center; University of Texas Southwestern Medical Center; Vanderbilt University; Vanderbilt University Medical Center; Wake Forest Baptist Health; Wake Forest University Health Sciences
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide