NCT04934475: Phase 3 - IFM 2020-02 Minimal Residual Disease Adapted Strategy (MIDAS) KRD-Isatuximab

IFM 2020-02

MInimal Residual Disease Adapted Strategy (MIDAS)

Isa-KRd

NCT04934475: Phase 3 - IFM 2020-02 -MInimal Residual Disease Adapted Strategy (MIDAS) - KRD-Isatuximab

IFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5).

Sponsor

Intergroupe Francophone du Myelome

Collaborators

Amgen

Sanofi

Bristol-Myers Squibb

Multiple Locations

French study

IFM

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ClinicalTrials.gov Identifier: NCT04934475

Official Title: MInimal Residual Disease Adapted Strategy: Frontline Therapy for Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years; a Prospective Study

First Posted : June 22, 2021

https://clinicaltrials.gov/ct2/show/NCT04934475

IFM

https://www.myelome.fr/

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Isatuximab : National Cancer Institute

Isatuximab : MedlinePlus Drug Information

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Drug: Isatuximab

Drug: Carfilzomib

Drug: Revlimid

Drug: Dexamethasone

ASCT

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Locations

France