RecruitingPhase 2NCT06517017

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

Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study

Sponsor

University of Utah

Enrollment

40 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Plasma Cell Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a gentler, slower-escalating version of a three-drug combination (isatuximab + lenalidomide + dexamethasone) for newly diagnosed multiple myeloma patients who are considered "ultra-frail" — too fragile for standard aggressive treatment due to age, weakness, or other health conditions. The "go-slow" approach gradually increases the dose to improve tolerability. **You may be eligible if...** - You are 18 or older - You have a newly diagnosed multiple myeloma (a blood cancer affecting plasma cells) or plasma cell leukemia - You have had at most 1 prior cycle of myeloma treatment - You are considered too frail for standard intensive therapy - Female patients of childbearing potential must have a negative pregnancy test or evidence of surgical sterilization **You may NOT be eligible if...** - You have already received more than 1 cycle of prior myeloma treatment - You have certain serious infections, severe organ failure, or other conditions incompatible with these medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsatuximab

Subcutaneous isatuximab will be administered weekly on a 28-day cycle during the first two cycles, and every two weeks of a 28-day cycle thereafter. Dexamethasone will be administered on the days of isatuximab administration and can be discontinued after two cycles of therapy, or continued at discretion of investigator. Lenalidomide, will be added after two cycles of therapy have been completed.