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NCT01191060: Phase 3 - IFM 2009 - (IFM/DFCI2009) Conventional dose RVD to High-Dose + ASCT -NDMM

Updated: Sep 27, 2022

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)

IFM2009

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:

Dana-Farber Cancer Institute

Celgene Corporation

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

 

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

Drug: Lenalidomide, Bortezomib

 

Early versus delayed autologous stem cell transplant in patients receiving novel therapies for multiple myeloma.

Leuk Lymphoma. 2013 Aug


Click here for details

 

IFM 2009 Study. Lenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma.

N Engl J Med. 2017 April


Click here for details

 

Minimal residual disease negativity using deep sequencing is a major prognostic factor in multiple myeloma

Blood;2018


Click here for details

 

Genome-Wide Somatic Alterations in Multiple Myeloma Reveal a Superior Outcome Group.

J Clin Oncol. 2020 Sep


Click here for details

 

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


Click here for details

 

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


Click here for details

 

Multiple Myeloma Minimal Residual Disease Detection: Targeted Mass Spectrometry in Blood vs Next-Generation Sequencing in Bone Marrow

Clin Chem;2021 Nov


Click here for details

 

"FU-IFM2009" Database Post IFM/DFCI 2009 Study (DB-FU-IFM2009)

ClinicalTrials.gov Identifier: NCT03679351

https://clinicaltrials.gov/ct2/show/NCT03679351


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

Click here for details


 

Location

France

Principal Investigator: MICHEL ATTAL, MD PhD

University Hospital of Toulouse

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