ELISA in Relapsed/Refractory MM

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 1, 2026

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2028

Conditions
Relapsed Refractory Multiple Myeloma (RRMM)Relapsed Refractory Multiple Myeloma
Interventions
DRUG

elranatamab

"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"

DRUG

Isatuximab 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"

DEVICE

Isatuximab 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.

Trial Locations (2)

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

Massachusetts General Hospital

OTHER