Elimination of Minimal Residual Disease After Transplant

PHASE2RecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

June 26, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

July 31, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

Dexamethasone

Dexamethasone will be used for the double purpose of premedication and therapeutic effect. On Day 1 of Cycle 1, subjects will be administered 40 mg dexamethasone as an IV infusion. On Days 8, 15, 22 of Cycle 1 and Days 1 and 15 of Cycles 2-4, dexamethasone will be given as a single oral dose of 40 mg. For Cycles 5-12, dexamethasone will be given as a single oral dose of 4 mg on Days 1 and 15.

DRUG

Isatuximab

Following premedication (if applicable), subjects will be given isatuximab 10 mg/kg body weight as an intravenous (IV) infusion on Days 1, 8, 15, and 22 (i.e., weekly) during Cycle 1 and on Days 1 and 15 (i.e., Q2W) during Cycles 2-12.

DRUG

Lenalidomide

On Days 1-21 for all 12 cycles, lenalidomide will be given to subjects as a single daily oral dose.

Trial Locations (1)

53226

RECRUITING

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee

All Listed Sponsors
lead

Medical College of Wisconsin

OTHER