• Active, not recruiting

NCT01208662- Phase 3 - DETERMINATION Trial: Delayed vs Early Transplant with RVd & Revlimid Maint.

Updated: Sep 7

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)


DETERMINATION TRIAL MYELOMA

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


BMT CTN 1304

 

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

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.


Click here to read abstract details

 

ABSTRACTS & PRESENTATIONS

2022 ASCO ANNUAL MEETING - June 3-7, 2022 - McCormick Place, Chicago, IL - Hybrid Meeting

2022 ASCO Annual Meeting - Plenary Session

Click here for details

 

N Engl J Med; 2022 Jun 5

Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma


Click here for details

 

TheASCOPost Newsreels; 6/5/2022

Including ASCT as Part of Initial Therapy Improves Progression-Free Survival in Newly Diagnosed Patients With Multiple Myeloma

Click here for details

 

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

Click here for details

 

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

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


#IMS2022 - 19th International Myeloma Society Annual Meeting; Aug 25-27, LA California (themyelomaclinicaltrials.com)

 

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

https://www.themyelomaclinicaltrials.com/single-post/ifm2009







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