Active, not recruiting
- Dec 24, 2021

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)

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.

Sponsor

Poitiers University Hospital

Collaborator

Intergroupe Francophone du Myelome

IFM

Sanofi

ClinicalTrials.gov 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

Click here to see details on ClinicalTrials.gov

IFM - Intergroupe Francophone du Myélome (myelome.fr)

Dexamethasone : National Cancer Institute

Isatuximab : National Cancer Institute

Dexamethasone : National Cancer Institute

Bortezomib : National Cancer Institute

Drug: Isatuximab

Drug: Lenalidomide

Drug: Bortezomib

Drug: Dexamethasone

Experimental: Isatuximab/Lenalidomide/Dexamethasone/Bortezomib