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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

August 28, 2020

Primary Completion Date

April 15, 2025

Study Completion Date

April 15, 2026

Conditions
Multiple Myeloma in RelapseMultiple Myeloma, Refractory
Interventions
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.

Trial Locations (1)

86000

CHU Poitiers, Poitiers

Sponsors

Collaborators (3)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Celgene

INDUSTRY

collaborator

Amgen

INDUSTRY

collaborator

Intergroupe Francophone du Myelome

NETWORK

lead

Poitiers University Hospital

OTHER