NCT05889221

Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Isatuximab was developed on a sub-cutaneous (SC) administration format. SC administration is expected to be more convenient for the patient, with a much shorter duration of administration compared to the currently approved IV route. The SC Isatuximab RP2D fixed dose was determined at 1400 mg in a phase1b assessing SC Isatuximab in combination with pomalidomide and dexamethasone in RRMM patients. A similar activity and a favorable safety administration profile compared to the IV formulation, was shown in this trial, as expected (Moreau et al, ASH 2021; Quach et al, ASCO 2022). This data should be confirmed in the ongoing IRAKLIA/EFC15951 phase 3 study, that compared in the RRMM, isatuximab plus pomalidomide and dexamethasone IV versus SC. Whether isatuximab SC, fixed 1400 mg dose, will show similar efficacy and safety profile as to anti-CD38Rd+V remains to be demonstrated. The investigators have planned to study the combination of SC isatuximab plus VRd (IsVRd) in patients with NDMM NTE in a phase 2 study across IFM (Intergroupe Francophone du Myeloma) centers in France to compare indirectly this data to the data obtained from studies that have studied this association in that population with the IV isatuximab formulation.

Conditions

• Multiple Myeloma
• Myeloma Multiple
• Myeloma

Interventions

Type	Name	Description
OTHER	Drug and medical device	Isatuximab will be administered in the hospital by an healthcare professional in the periumbilical region at a single site, using an investigational device injector; injection site will be rotated from one administration to the other.

Timeline

• Start date: 2023-10-23
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2023-06-05
• Last updated: 2024-09-05

Locations

1 site across 1 country: France