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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


University Hospital, Toulouse


Janssen-Cilag Ltd.

Information provided by (Responsible Party):

University Hospital, Toulouse 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

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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


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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) Identifier: NCT03679351

Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 (DFCI 10-106)




Principal Investigator: MICHEL ATTAL, MD PhD

University Hospital of Toulouse


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