Isatuximab + Dexamethasone + Lenalidomide for Multiple Myeloma
(UltraFrailMM Trial)

Recruiting in Palo Alto (17 mi)

Overseen byGhulam Rehman Mohyuddin, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for ultra-frail patients with multiple myeloma who often have difficulty tolerating standard treatments. It's designed to test if starting treatment slowly improves their ability to stick with the therapy and enhances their quality of life.

Inclusion Criteria

IMWG defined frailty score ≥ 3. IMWG definition available here: http://www.myelomafrailtyscorecalculator.net

I agree to use a latex condom during sex throughout the study, even though I've had a vasectomy.

I agree to follow the birth control requirements and participate in the Lenalidomide REMS program.

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Exclusion Criteria

Receiving other investigational agents

I am severely allergic to certain drugs or ingredients used in this study.

Any condition that would, in the Investigator's judgment, compromise the subject's ability to understand the subject information, give informed consent, and/or contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, subjects may not receive the drug through a feeding tube, social/ psychological issues, etc.)

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Treatment Details

Interventions

Isatuximab (Monoclonal Antibodies)

Trial OverviewThe study tests a 'go-slow' approach using Isatuximab and Dexamethasone initially, then gradually introducing Lenalidomide from the third cycle onwards. The aim is to see if this method reduces early treatment mortality and increases adherence in frail patients.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Combination TreatmentExperimental Treatment1 Intervention

Isatuximab

Isatuximab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Sarclisa for:

Multiple myeloma

🇺🇸 Approved in United States as Sarclisa for:

Multiple myeloma in combination with pomalidomide and dexamethasone for adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
Multiple myeloma in combination with carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
Newly diagnosed multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for adults who are not eligible for autologous stem cell transplant