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Status: RecruitingPhase: Phase 3Diagnosis: Multiple MyelomaNCT ID: NCT01208662
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-106
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.
Conducting Institutions: Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital
Overall PI: Paul Richardson, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators: David Avigan, MD,
Beth Israel Deaconess Medical CenterNoopur Raje, MD,
Massachusetts General Hospital
Contacts: Dana-Farber Cancer Institute:
Muriel Gannon, 617-632-4597,
email@example.comMassachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060