KRDI in Transplant-Eligible MM

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 10, 2020

Primary Completion Date

July 30, 2022

Study Completion Date

March 30, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

Carfilzomib

"* Induction: protocol determine dose,via IV on 3 days per cycle up to 8 cycles, dependent on Upfront Stem Transplant or Deferring Stem Cell Transplant determination~* Maintenance: protocol determine dose,via IV on 2 days per cycle- Maintenance Cycle until progressive disease (PD) or unacceptable toxicity"

DRUG

Isatuximab

"* Induction: At predetermined dose, via IV up to 8 cycles, dependent on Upfront Stem Transplant or Deferring Stem Cell Transplant determination:~ \-- Cycles 1 and 2 once per week, Cycles 3-4 every other week, Cycles 5 and 6 every other week, Cycles 7 and 8 once every 4 weeks.~* Maintenance: At predetermined dose, via IV, once per cycle, Maintenance Cycle until progressive disease (PD) or unacceptable toxicity"

DRUG

Lenalidomide

\- Induction Predetermined Dose, oral, days 1-21 of up to 8 cycles, dependent on Upfront Stem Transplant or Deferring Stem Cell Transplant determination Maintenance: At predetermined dose, oral days 1-21 per cycle until progressive disease (PD) or unacceptable toxicity

DRUG

Dexamethasone

Induction: Predetermined dosage, oral, Predetermined times per cycle up to 8 cycles dependent on Upfront Stem Transplant or Deferring Stem Cell Transplant determination Maintenance: orally or IV will be administered as a preinfusion medication prior to isatuximab dosing

Trial Locations (3)

02115

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

Massachusetts General Hospital

OTHER