NCT04287855

Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma. Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase

Conditions

• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
DRUG	Isatuximab	Isatuximab by IV route - Cycle 1 : 10mg/kg on days 1, 8, 15 and 22 per 28 days cycle. After cycle 1 : 10mg/kg on days 1 and 15 per 28 days cycle
DRUG	Carfilzomib	Carfilzomib by IV route - Cycle 1 : 20/27 mg/m² on days 1-2, 8-9, 15-16 per 28 days cycle. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle.
DRUG	Pomalidomide	Pomalidomide by oral route - Cycle 1-2 : 3mg on days 1 to 21 per 28 days cycle. After cycle 2 : 4mg on days 1 to 21 per 28 days cycle.
DRUG	Dexamethasone	Dexamethasone by oral route - Cycle 1-13 : 40/20 mg on days 1, 8, 15 and 22. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle.

Timeline

• Start date: 2020-08-28
• Primary completion: 2025-04-15
• Completion: 2026-04-15
• First posted: 2020-02-27
• Last updated: 2023-01-10

Locations

1 site across 1 country: France