Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

June 24, 2025

Study Completion Date

December 15, 2027

Conditions
Multiple Myeloma
Interventions
DRUG

Isatuximab

Isatuximab (IV): 10 mg/kg on Days 1, 8, 15, 22, 29 in Cycle 1; from Cycle 2 onwards, it will be given on Days 1, 15, 29.

DRUG

Bortezomib

Bortezomib (SQ): 1.3 mg/m² on Days 1, 4, 8, 11, 22, 25, 29, and 32.

DRUG

Lenalidomide

Lenalidomide (PO): 25 mg/day (10 mg/day for patients with creatinine clearance \[CrCl\] ≥30 to \<60 mL/min) from Day 1 to Day 14 and from Day 22 to Day 35 of each cycle.

DRUG

Dexamethasone (IV)

Dexamethasone (IV on the days of Isatuximab and PO on other days): 20 mg/day on Days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23, 25, 26, 29, 30, 32, and 33. If patients are ≥75 years old, dexamethasone will be administered on Days 1, 4, 8, 11, 15, 16, 22, 25, 29 and 32.

Trial Locations (5)

Unknown

Aarhus University Hospital, Aarhus

Beaumont Hospital, Dublin

Mater Misericordiae University Hospital, Dublin

St James's Hospital, Dublin

University Hospital Waterford, Waterford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Dana-Farber Cancer Institute

OTHER

lead

Cancer Trials Ireland

NETWORK