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  • Active, not recruiting

NCT04751877: Phase 3 - Isa-Rd +/- Bortezomib Non Frail NTE Myeloma Elderly Patients IFM2020-05

Updated: Feb 10

  • (IFM 2020-05)

  • BENEFIT IFM 2020-05

  • Study of Isatuximab+Lenalidomide+Dexamethasone With/Without Bortezomib in de Novo Non Frail NTE Multiple Myeloma Elderly Patients (IFM2020-05)

IFM 2020

The association lenalidomide and dexamethasone (Rd) has significantly improved the easiness of treating the NTE population and all drugs seem to be possible to combine to Rd. In that extent, proteasome inhibitors have always been one of the most impactful family of agents in MM, and as expected Bortezomib plus Rd has become a very relevant and commonly used regimen in NTE NDMM. These groundbreaking results have favored the development of 2 randomized phase 3 studies for registration of combination of antiCD38Mab (Daratumumab (Cepheus, NCT03652064), Isatuximab (Imroz, NCT03319667) +Rd +Velcade in comparison to VRd. Both studies have used as a comparator the VRd regimen which is today one of the safest, active and popular triplet based Rd regimen, approved, and therefore the best control arm possibly for these studies.

However, as much as there has been no direct head to head comparison of VRd to Dara Rd, when looking at the data from Maia it is anticipated that DRd will become a standard of care, and might challenge strongly VRd. Yet, multiple questions remain still, anticipating the change in backbone from VRd to antiCD38 +Rd becoming the new standard of care for NTE NDMM patients. The investigators have therefore planned to answer the critical question of the role of proteasome inhibitors in NTE non frail NDMM when considering anti CD38 +Rd as the backbone.



IFM Identifier: NCT04751877

Official Title: Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years)

First Posted : February 12, 2021

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Drug: Isatuximab

Drug: Lenalidomide

Drug: Bortezomib

Drug: Dexamethasone


Experimental: Isatuximab/Lenalidomide/Dexamethasone/Bortezomib

Active Comparator: Isatuximab/Lenalidomide/Dexamethasone


IFM 2020

French Study


Poitiers, France, 86000



NCT03710603: Phase 3 (Perseus) EMN17 - Dara-VRd Vs VRd - Daratumumab, VELCADE, Len, Dex VS VELCADE, Len, Dex in NDMM

NCT03652064: Phase 3 (CEPHEUS) MMY3019 - Dara-VRd Vs VRd - Bortezomib, Lenalidomide, Dex and +/- Daratumumab - NDMM

NCT04566328: Phase 3 (EQUATE) - EAA181 - Dara-VRd Vs Dara-Rd - Testing the Use of Combination Therapy in NDMM

NCT02195479: Phase 3 (ALCYONE) Dara-VMP Vs VMP - Bortezomib, Melphalan, Prednisone & Daratumumab

NCT02541383: Phase 3 (CASSIOPEIA) Dara-VTd Vs VTd - Bortezomib, thalidomide, dex +/-Daratumumab before & after ASCT

NCT02874742: Phase 2 (GRIFFIN) - Dara-VRd Vs VRd - Daratumumab, Len., Bortezomib & Dex in NDMM

NCT04268498: Phase2 (ADVANCE) Dara-KRd - Daratumumab, Carfilzomib, Lenalidomide, Dex NDMM Multiple Myeloma

NCT03290950: Phase 2 (Manhattan) Dara-KRd - A Study of Daratumumab in Patients With NDMM wKRd-D

NCT02252172: Phase 3 (MAIA) Dara-Rd Vs Rd - Dara, Lena & Dex VS Len & Dex in previously untreated Myeloma

NCT03729804: Phase 3 (COBRA) - KRd Vs VRd in Patients with Newly Diagnosed Multiple Myeloma

NCT04096066: Phase 3 KRd Vs Rd - A Trial That Compare Two Treatments TIE - NDMM

NCT01402284: Phase 2 - KRd - Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients


NCT04483739: Phase 3 (Iskia) - Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Eligible for ASCT

NCT03319667: Phase 3 (IMROZ) - Isa-VRd Vs VRd - Isatuximab, Bortezomib, Lenalidomide and Dex NDMM


NCT04923893: Phase 3 (CARTITUDE-5) VRd --> Cilta-cel Vs VRd --> Rd - NDMM- (No ASCT planned)

NCT05257083: Phase 3 (CARTITUDE-6) DVRd -> Ciltacabtagene Autoleucel Vs DVRd -> Transplant ASCT- NDMM


NCT01850524: Phase 3 (TOURMALINE-MM2) Ixa-Rd Vs Rd - Oral Ixazomib + Lenalidomide/Dex Vs Placebo + Len/Dex NDMM


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