Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 18, 2022

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2031

Conditions
Multiple MyelomaCancer
Interventions
DRUG

Isatuximab

Pharmaceutical form: Solution for infusion Route of administration: Intravenous Isatuximab:10 mg/kg intravenous or 1400 mg subcutaneous (SC) via on-body delivery system (OBDS) will be administered in cycles 1-24.

DRUG

Lenalidomide

"Pharmaceutical form: Capsule for oral use, Route of administration: Oral Lenalidomide capsule will be given oral, the dose will be adjusted according to glomerular filtration rate (GFR): 15 mg daily if GFR \> 60 mL/min, 5 mg daily if GFR 30-60 mL/min, 2.5 mg daily if GFR \< 30 mL/min. Note that dialysis-dependence comprises an exclusion criterion for this study.~Lenalidomide will be continued until disease progression, excessive toxicity or death."

DRUG

Dexamethasone

Pharmaceutical form: Tablet for oral use, Route of administration: Oral Dexamethasone tablet will be given oral: 20 mg given on days 1, 8, 15 and 22 of cycles 1-8. Administration may continue beyond cycle 8, if needed, for the prevention of infusion reactions.

Trial Locations (5)

27599

RECRUITING

University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, Chapel Hill

27710

RECRUITING

Duke Comprehensive Cancer Center, Durham

28204

RECRUITING

Levine Cancer Institute, Charlotte

28401

RECRUITING

Novant Health New Hanover Regional Medical Center, Wilmington

43210

RECRUITING

The Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors
collaborator

Genzyme, a Sanofi Company

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER