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
Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? Lenalidomide+Bortezomib+Dexamethasone
Status: Active_not_recruiting
Location: See all (46) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic Criteria
• Documented symptomatic myeloma, with organ damage related to myeloma with laboratory assessments performed within 21 days of registration
• Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains.
• ECOG performance status \</= 2
• Negative HIV blood test
• Voluntary written informed consent
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
Arizona Comprehensive Cancer Center
Tucson
California
City of Hope
Duarte
University of California at San Diego
La Jolla
University of California, San Francisco
San Francisco
Stanford University
Stanford
Colorado
Colorado Blood Cancer Institute
Denver
Florida
University of Florida
Gainesville
H. Lee Moffitt Cancer Center
Tampa
Georgia
Emory University
Atlanta
Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise
Illinois
University of Chicago
Chicago
Louisiana
Ochsner Foundation Clinic
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Cape Cod Healthcare
Hyannis
Newton-Wellesley Hospital
Newton
Maine
Eastern Maine Medical Center
Brewer
Michigan
University of Michigan
Ann Arbor
Barbara Ann Karmanos Cancer Institute
Detroit
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Duke University
Durham
Wake Forest University
Winston-salem
New Hampshire
New Hampshire Oncology and Hematology
Concord
New Hampshire Oncology and Hematology
Hooksett
New Hampshire Oncology and Hematology
Laconia
New York
State University of New York Downstate Medical Center
Brooklyn
Roswell Park Cancer Institute
Buffalo
North Shore Long Island Jewish Health System
Lake Success
Columbia University
New York
Memorial Sloan Kettering Cancer Center
New York
Mount Sinai Medical Center
New York
University of Rochester Medical Center
Rochester
Ohio
Ohio State University Medical Center
Columbus
Oregon
Oregon Health and Sciences
Portland
Pennsylvania
Fox Chase Cancer Center
Philadelphia
University of Pennsylvania Medical Center
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
Tennessee
Vanderbilt University
Nashville
Texas
University of Texas Southwestern Medical Center
Dallas
Baylor College of Medicine
Houston
MD Anderson Cancer Center
Houston
Utah
Huntsman Cancer Institute
Salt Lake City
Washington
Fred Hutchinson Cancer Research Center
Seattle
Time Frame
Start Date: 2010-10
Completion Date: 2026-12
Participants
Target number of participants: 729
Treatments
Experimental: RVD Alone
All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse.~RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
Active_comparator: RVD plus ASCT
All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study.~After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant.~RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
Authors
Michael W Becker, Amit Agarwal, Thomas Openshaw, Myron Czuczman, Amrita Krishnan, Adam D Cohen, William H Kreisle, Larry Anderson, William Bensinger, Noopur Raje, Ruthee-Lu Bayer, Jeffrey Zonder, Rammurti Kamble, Tondre Buck, Caroline Block, Daniel Couriel, Jan Moreb, Yvonne Efebera, Douglas Weckstein, Paul Richardson, Jeffrey V Matous, Sundar Jagannath, David Hurd, Michaela Liedtke, Frank Basile, Peter Voorhees, Sagar Lonial, Mounzer Agha, David Avigan, Gurinder Sidhu, Hani Hassoun, Caitlin Costello
Related Therapeutic Areas
Sponsors
Collaborators: University of Florida, Vanderbilt University Medical Center, Stanford University, Newton-Wellesley Hospital, University of Arizona, Icahn School of Medicine at Mount Sinai, University of Michigan, Cape Cod Hospital, Beth Israel Deaconess Medical Center, Duke University, University of Pittsburgh Medical Center, Millennium Pharmaceuticals, Inc., University of Mississippi Medical Center, UNC Lineberger Comprehensive Cancer Center, Memorial Sloan Kettering Cancer Center, Columbia University, Wake Forest University Health Sciences, State University of New York - Downstate Medical Center, Huntsman Cancer Institute, Roswell Park Cancer Institute, Baylor College of Medicine, Ohio State University, City of Hope Medical Center, University of California, San Diego, Emory University, Fred Hutchinson Cancer Center, Northwell Health, Massachusetts General Hospital, Ochsner Health System, Eastern Maine Medical Center, H. Lee Moffitt Cancer Center and Research Institute, Fox Chase Cancer Center, M.D. Anderson Cancer Center, University of Texas Southwestern Medical Center, OHSU Knight Cancer Institute, Barbara Ann Karmanos Cancer Institute, University of Alabama at Birmingham, University of Chicago, University of California, San Francisco, Celgene Corporation
Leads: Paul Richardson, MD