Spots Global Cancer Trial Database for Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
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Trial Identification
Brief Title: Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
Official Title: 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
Study ID: NCT01208662
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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. After screening procedures determine if a patient is eligible for this research study, the patient will be randomized into one of the study groups: lenalidomide, bortezomib and dexamethasone without autologous stem cell transplantation, followed by lenalidomide maintenance (Arm A) or lenalidomide, bortezomib and dexamethasone with autologous stem cell transplantation, followed by lenalidomide maintenance (Arm B). There is an equal chance of being placed in either group. Randomization was stratified by International Staging System (ISS) disease stage (I, II, or III) and cytogenetics (high-risk \[presence of 17p deletion, t(4;14), or t(14;16) on fluorescence in-situ hybridization\], standard-risk \[absence of high-risk abnormalities\], or undetermined \[test failure\]) assessed locally in a screening bone marrow sample, with positivity cut-offs per institutional standards.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Comprehensive Cancer Center, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
University of California at San Diego, La Jolla, California, United States
University of California, San Francisco, San Francisco, California, United States
Stanford University, Stanford, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
University of Florida, Gainesville, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho, United States
University of Chicago, Chicago, Illinois, United States
Ochsner Foundation Clinic, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Brewer, Maine, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Cape Cod Healthcare, Hyannis, Massachusetts, United States
Newton-Wellesley Hospital, Newton, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
New Hampshire Oncology and Hematology, Concord, New Hampshire, United States
New Hampshire Oncology and Hematology, Hooksett, New Hampshire, United States
New Hampshire Oncology and Hematology, Laconia, New Hampshire, United States
State University of New York Downstate Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
North Shore Long Island Jewish Health System, Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Columbia University, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Duke University, Durham, North Carolina, United States
Wake Forest University, Winston-Salem, North Carolina, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Oregon Health and Sciences, Portland, Oregon, United States
University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
Name: Paul G. Richardson, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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