RecruitingPhase 2NCT06832865

ELISA in Relapsed/Refractory MM

A Phase 2 Study of Elranatamab in Combination With Isatuximab (ELISA) in Relapsed and Refractory Multiple Myeloma

Sponsor

Massachusetts General Hospital

Enrollment

30 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsed Refractory Multiple Myeloma (RRMM)

Summary

This is an open-label phase 2 study of elranatamab in combination with isatuximab administered subcutaneously in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy and who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). The subcutaneous injection method of isatuximab administration, including the device used to administer isatuximab, is investigational.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called ELISA) is testing a combination of drugs — elranatamab, isatuximab, and lenalidomide — in patients with relapsed/refractory multiple myeloma (a blood cancer that has come back or stopped responding to previous treatments). Patients must have already tried at least two prior treatment regimens. **You may be eligible if...** - You have multiple myeloma that has relapsed (come back) or is refractory (stopped responding to treatment) - You have had at least 2 prior lines of therapy, including both an immunomodulatory drug (IMiD) and a proteasome inhibitor - You have measurable cancer activity in blood or urine tests - Prior treatment with anti-CD38 therapy is allowed, but you must not be currently resistant to it **You may NOT be eligible if...** - You have previously received an anti-BCMA T cell engager therapy - You are refractory (no longer responding) to an anti-CD38 antibody - Your organ function does not meet required levels 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

DRUGelranatamab

Subcutaneously injected study drug, usually into the abdomen or lower stomach. Each vial of elranatamab contains a sufficient amount of product to ensure an extractable volume of 1.9 mL at a concentration of 40 mg/mL. The dosing is as follows: * Cycle 1 Day 1: 12 mg/0.3 mL * Cycle 1 Day 4: 32 mg/0.8 mL * Cycle 1 Day 8, 15, 22: 76 mg/1.9 mL * Cycles 2-6, Day 1 and 15: 76 mg/1.9 mL * Cycles 7+, Day 1: 76 mg/1.9 mL

DRUGIsatuximab SC

Isatuximab (SAR650984) is an IgG1 derived monoclonal antibody binding selectively the human CD38 membrane protein. Subcutaneously (SC) injected study drug with each vial containing 140 mg/mL (1400 mg/10mL) isatuximab. Isatuximab SC will be injected using the investigational OBDS and in the following doses: * Cycles 2-6, Day 1 and 15: 1400 mg/10 mL * Cycles 7+ Day 1: 1400 mg/10 mL

DEVICEIsatuximab SC-OBDS

The On Body Delivery System (OBDS) also called Isatuximab SC Wearable Injection System, is a sterile, single-use, disposable, elastomeric, user-filled investigational medical device. The OBDD has a reservoir for the drug product (isatuximab). A self-contained, integrated needle (with manual insertion and automatic retraction mechanism) is provided within the OBDS. The OBDS will be used to inject isatuximab each time the participant receives isatuximab in this study. Study drug administration will be done by trained medical professionals in the clinic. The OBDS device will be prepared by the medical professional, placed on the abdomen using the adhesive (sticky) pads that are on the device, the study drug (isatuximab) will be injected, and then the device will be removed.