NCT01191060: Phase 3 - IFM 2009 - (IFM/DFCI2009) Conventional dose RVD to High-Dose + ASCT -NDMM
Updated: Jan 27
IFM 2009
IFM/DFCI2009
The Intergroupe Francophone du Myelome 2009 trial
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years (IFM/DFCI2009)
NCT01191060: Phase 3 - Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years (IFM/DFCI2009)
Objective of this study 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. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months).
Study design Phase III, multicenter, randomized, open-label study designed to evaluate the clinical benefit from the drug combination RVD without immediate high-dose therapy (HDT) followed by lenalidomide maintenance (Arm A) versus RVD plus HDT and PBSCT followed by lenalidomide maintenance (Arm B).
French Study
Sponsor:
University Hospital, Toulouse
Collaborators:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01191060
Official Title: Randomized Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone to High-Dose Treatment With ASCT in the Initial Management of Myeloma in Patients up to 65 Years of Age
First Posted : August 30, 2010
Click here for details on ClinicalTrials.gov
Drug: Lenalidomide, Bortezomib
Early versus delayed autologous stem cell transplant in patients receiving novel therapies for multiple myeloma.
Leuk Lymphoma. 2013 Aug
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IFM 2009 Study. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma.
N Engl J Med. 2017 April
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Minimal residual disease negativity using deep sequencing is a major prognostic factor in multiple myeloma
Blood;2018
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Genome-Wide Somatic Alterations in Multiple Myeloma Reveal a Superior Outcome Group.
J Clin Oncol. 2020 Sep
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Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma.
Leuk Lymphoma. 2020 Jun
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143 Early Versus Late Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma: Long-Term Follow-up Analysis of the IFM 2009 Trial
Program: Oral and Poster Abstracts
Type: Oral
Session: 731. Clinical Autologous Transplantation: Autologous Transplantation: Still the Backbone of Modern Myeloma Therapies
Hematology Disease Topics & Pathways:
multiple myeloma, therapy sequence, Diseases, Therapies, Combinations, Plasma Cell Disorders, Lymphoid Malignancies, Clinically relevant
Saturday, December 5, 2020: 10:00 AM
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Multiple Myeloma Minimal Residual Disease Detection: Targeted Mass Spectrometry in Blood vs Next-Generation Sequencing in Bone Marrow
Clin Chem;2021 Nov
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"FU-IFM2009" Database Post IFM/DFCI 2009 Study (DB-FU-IFM2009)
ClinicalTrials.gov Identifier: NCT03679351
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 (DFCI 10-106)
Location
France
Principal Investigator: MICHEL ATTAL, MD PhD
University Hospital of Toulouse