A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age
ID Number 12-1505Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the U.S. Food and Drug Administration (FDA). They have not been approved in this combination for use for newly diagnosed Multiple Myeloma and any other type of cancer. Bortezomib is currently approved by the U.S. FDA for the treatment of people with multiple myeloma. Lenalidomide is currently approved for use with dexamethasone for people with multiple myeloma who have received at least one prior therapy and for the treatment of certain types of myelodysplastic syndrome (another form of cancer affecting the blood). Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the U.S. 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 research studies in people with multiple myeloma and information from those other research studies suggests that this combination of therapy may help to treat newly diagnosed multiple myeloma in this research study.
The purpose of this study is 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.
To be able to participate in this research study patients must have been newly diagnosed with multiple myeloma.
Recruiting Patients: Yes