Overview

A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor

Status:
Not yet recruiting

Trial end date:
2026-01-01

Target enrollment:

Participant gender:

Summary

This is an investigator-initiated (IIS), phase 2, prospective, open-label, multinational study, designed to be conducted in approximately 14 sites. Eligible patients will initially receive six 28-day cycles of isatuximab, pomalidomide, and low-dose dexamethasone. Following this phase: Patients who achieve ≥VGPR will be randomized in a 1:1 ratio to receive isatuximab, given either Q2W or once monthly, plus pomalidomide and low-dose dexamethasone. Patients with Phase: Phase 2

Details

Lead Sponsor:

Hellenic Society of Hematology

Collaborator:

Sanofi

Treatments:

Acetaminophen
Dexamethasone
Diphenhydramine
Pomalidomide
Promethazine
Ranitidine
Ranitidine bismuth citrate