NCT01208662- Phase 3 - DETERMINATION Trial: Delayed vs Early Transplant with RVd & Revlimid Maint.
Updated: Jan 27
NDMM - DFCI 10-106
DETERMINATION Trial
Delayed vs Early Transplant with Revlimid Maintenance and Anti-Myeloma Triple Therapy
DFCI 10-106
IFM DFCI 2009
BMT CTN Protocol 1304
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 (DFCI 10-106)
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 (DFCI 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.
Sponsor
Paul G. Richardson, MD
Multiple Locations
ClinicalTrials.gov Identifier: NCT01208662
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
First Posted : September 24, 2010
Click here to see details on ClinicalTrials.Gov
Meeting: 2022 ASCO Annual Meeting - Session Type: Plenary Session - Session Title: Plenary Session Track: Special Sessions - Sub Track: Special Sessions - Clinical Trial Registration Number: NCT01208662
Abstract#: LBA4 - Lenalidomide, bortezomib, and dexamethasone (RVd) ± autologous stem cell transplantation (ASCT) and R maintenance to progression for newly diagnosed multiple myeloma (NDMM): The phase 3 DETERMINATION trial.
ABSTRACTS & PRESENTATIONS
2022 ASCO ANNUAL MEETING - June 3-7, 2022 - McCormick Place, Chicago, IL - Hybrid Meeting
2022 ASCO Annual Meeting - Plenary Session
N Engl J Med; 2022 Jun 5
Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma
TheASCOPost Newsreels; 6/5/2022
Including ASCT as Part of Initial Therapy Improves Progression-Free Survival in Newly Diagnosed Patients With Multiple Myeloma
News Releases | Dana-Farber Cancer Institute | Boston, MA
JUNE 05, 2022
Improved progression-free survival in patients with multiple myeloma following three-drug therapy with autologous stem cell transplant
OAB-058 - Lenalidomide-bortezomib-dexamethasone (RVd) ± autologous stem cell transplantation (ASCT) and R maintenance to progression in patients with newly diagnosed multiple myeloma (NDMM), by cytogenetic risk
#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California
Collaborators
Dana-Farber Cancer Institute
Celgene Corporation
Millennium Pharmaceuticals, Inc.
Massachusetts General Hospital
Cape Cod Hospital
Beth Israel Deaconess Medical Center
Emory University
University of Michigan
Fox Chase Cancer Center
Memorial Sloan Kettering Cancer Center
Fred Hutchinson Cancer Research Center
Barbara Ann Karmanos Cancer Institute
Duke University
University of California, San Francisco
University of Chicago
M.D. Anderson Cancer Center
UNC Lineberger Comprehensive Cancer Center
Roswell Park Cancer Institute
Stanford University
University of Mississippi Medical Center
Icahn School of Medicine at Mount Sinai
Wake Forest University Health Sciences
University of Arizona
OHSU Knight Cancer Institute
Eastern Maine Medical Center
University of California, San Diego
University of Alabama at Birmingham
University of Pittsburgh Medical Center
Ochsner Health System
University of Texas Southwestern Medical Center
State University of New York - Downstate Medical Center
Newton-Wellesley Hospital
Baylor College of Medicine
City of Hope Medical Center
University of Florida
Northwell Health
H. Lee Moffitt Cancer Center and Research Institute
Vanderbilt University Medical Center
Ohio State University
Huntsman Cancer Institute
Columbia University
Locations
United States, Alabama
United States, Arizona
United States, California
United States, Colorado
United States, Florida
United States, Georgia
United States, Idaho
United States, Illinois
United States, Louisiana
United States, Maine
United States, Massachusetts
United States, Michigan
United States, Mississippi
United States, New Hampshire
United States, New York
United States, North Carolina
United States, Ohio
United States, Oregon
United States, Pennsylvania
United States, Tennessee
United States, Texas
United States, Utah
United States, Washington
IFM 2009
NCT01191060: Phase 3 - IFM 2009 - (IFM/DFCI2009) Conventional dose RVD to High-Dose + ASCT -NDMM
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years (IFM/DFCI2009)
IFM 2009