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ACTIVE NOT RECRUITING
NCT05123131
PHASE2

Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma

Sponsor: Cancer Trials Ireland

View on ClinicalTrials.gov

Summary

This study aims to evaluate the stringent Complete Response (sCR) rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved sCR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.

Official title: Isa-RVD Study: Phase II, Multi-centre, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of the Combination Regimen Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2022-04-01

Completion Date

2027-12-15

Last Updated

2025-07-08

Healthy Volunteers

No

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.

Locations (5)

Aarhus University Hospital

Aarhus, Denmark

Beaumont Hospital

Dublin, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

St James's Hospital

Dublin, Ireland

University Hospital Waterford

Waterford, Ireland