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Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
Sponsor: Paul Richardson, MD
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.
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
729
Start Date
2010-09
Completion Date
2026-12
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Lenalidomide
oral administration
Bortezomib
intravenous or, following protocol amendment, subcutaneous administration
Dexamethasone
oral administration Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles.
Autologous Stem Cell Transplant
Autologous refers to stem cells that are harvested from the participant to be a source of new blood cells after high-dose chemotherapy with melphalan.
Locations (46)
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