Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma

Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.

NCT Number	NCT06517017
Lead Sponsor	University of Utah Collaborators: Sanofi
Conditions	Multiple Myeloma, Plasma Cell Leukemia
Enrollment	40 participants
Start Date	2025-10-09
Primary Completion	2026-11 (estimated)
Study Completion	2027-11 (estimated)
Updated on ClinicalTrials.gov	2025-11-28