drugset / Trial / NCT06517017

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

NCT06517017

Phase 2 Recruiting 40 enrolled University of Utah Sanofi · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-10-09
Primary completion
2026-11
Completion
2027-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule
Subject Isatuximab Monoclonal antibody Subcutaneous
Subject Lenalidomide Other / unclassified