31
Participants
Start Date
June 26, 2023
Primary Completion Date
June 30, 2026
Study Completion Date
July 31, 2026
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.
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.
Lenalidomide
On Days 1-21 for all 12 cycles, lenalidomide will be given to subjects as a single daily oral dose.
RECRUITING
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee
Medical College of Wisconsin
OTHER