MInimal Residual Disease Adapted Strategy

Summary

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).

Timeline

Start

2021-12-08

Primary completion

2024-09-30

Completion

2028-09-30

Outcome

Missed primary endpoint

paper the percentage with a premaintenance MRD-negative status at 10-6 sensitivity was not significantly higher with ASCT than with Isa-KRd. PMID 40459097 ↗

paper the percentage with a premaintenance MRD-negative status at 10-6 sensitivity was not significantly higher with tandem ASCT than with single ASCT. PMID 40459097 ↗

Publications

• Perrot A, Lambert J, Hulin C, Pieragostini A, Karlin L, Arnulf B, Rey P, Garderet L, Macro M, Escoffre-Barbe M, Gay J, Chalopin T, Gounot R, Schiano JM, Mohty M, Leleu X, Manier S, Mariette C, Chaleteix C, Braun T, De Prijck B, Avet-Loiseau H, Mary JY, Corre J, Moreau P, Touzeau C; MIDAS Study Group. Measurable Residual Disease-Guided Therapy in Newly Diagnosed Myeloma. N Engl J Med. 2025 Jul 31;393(5):425-437. doi: 10.1056/NEJMoa2505133. Epub 2025 Jun 3.
• Perrot A, Touzeau C, Lambert J, Hulin C, Caillot D, Karlin L, Arnulf B, Rey P, Garderet L, Macro M, Escoffre Barbe M, Gay J, Chalopin T, Gounot R, Schiano JM, Tiab M, Mohty M, Kuhnowski F, Fontan J, Manier S, Orsini-Piocelle F, Vincent L, Rigaudeau S, Leleu X, Hebraud B, Flet L, Malfuson JV, Jacquet C, Chaoui D, Meuleman N, Abarah W, Montes L, Benramdane R, Sonntag C, Zerazhi H, Danu A, Allangba O, Dib M, Roussel M, Cereja S, Depaus J, Branche N, Demarquette H, Richez V, Cherel B, Frenzel L, Vekemans MC, Bigot N, Avet-Loiseau H, Corre J, Moreau P. Isatuximab, carfilzomib, lenalidomide, and dexamethasone induction in newly diagnosed myeloma: analysis of the MIDAS trial. Blood. 2025 Jul 3;146(1):52-61. doi: 10.1182/blood.2024026230.
• Mohan M, Gundarlapalli S, Szabo A, Yarlagadda N, Kakadia S, Konda M, Jillella A, Fnu A, Ogunsesan Y, Yarlagadda L, Thalambedu N, Munawar H, Graziutti M, Al Hadidi S, Alapat D, Thanendrarajan S, Zangari M, van Rhee F, Schinke C. Tandem autologous stem cell transplantation in patients with persistent bone marrow minimal residual disease after first transplantation in multiple myeloma. Am J Hematol. 2022 Jun 1;97(6):E195-E198. doi: 10.1002/ajh.26530. Epub 2022 Mar 21. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isatuximab	Monoclonal antibody	10 mg/kg	Intravenous

Indications