Clinical Trial

Isa-Pom-Dex in Elderly/Frail Subjects With RRMM

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2023-06-09; most recent amendment 2026-06-05.
Status change: Suspended → Active, Not Recruiting 2025-04-21
Status change: Recruiting → Suspended 2025-03-21
Status change: Not Yet Recruiting → Recruiting 2024-01-24
Trial Details
NCT Number NCT05911321
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: Genzyme, a Sanofi Company
Conditions Multiple Myeloma, Relapse, Refractory, Aging, Co-morbidity
Enrollment 6 participants
Start Date 2023-12-05
Primary Completion 2025-06-18 (estimated)
Study Completion 2028-03-26 (estimated)
Updated on ClinicalTrials.gov 2026-06-09