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Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma

NCT07624513 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2026-06-03

No results posted yet for this study

Summary

The purpose of the study is to determine the best treatment approach based on the risk profile of the cancer cells and on how the disease responds to treatment. This is a randomized research study evaluating treatment for transplant-eligible participants with newly diagnosed multiple myeloma. Induction therapy in this study includes the drugs isatuximab, iberdomide, bortezomib, and dexamethasone. After induction therapy, participants will receive consolidation and maintenance therapy that is adapted based on their risk profile and response to treatment.

The research study procedures include: screening for eligibility, study visits, blood and bone marrow tests, disease assessments, treatment with study drugs, and follow-up visits.

It is expected that about 720 participants will take part in this study.

Conditions

Interventions

DRUG

Isatuximab

Supplied by Sanofi-Aventis (Sanofi); used in induction and maintenance/consolidation strategies in this protocol; administered subcutaneously in the maintenance tables provided; not administered in Arm C.

DRUG

Iberdomide

Supplied by Bristol Myers Squibb/Celgene (BMS); used across induction and maintenance phases; administered orally.

DRUG

Bortezomib (B)

Commercial supply; used in induction and Arm G maintenance; administered subcutaneously in Arm G on Days 1 and 15 of each 28-day cycle.

DRUG

Dexamethasone

Commercial supply; used in induction; may be administered intravenously or orally at investigator discretion; excluded from Arm G.

DRUG

Melphalan

Commercial supply; used as conditioning therapy for Arm E before PBSC infusion/ASCT; administered intravenously.

DRUG

Linvoseltamab

Supplied by Regeneron; used in Arm F consolidation for 8 cycles before maintenance therapy.

DEVICE

On Body Delivery System (OBDS)

Device: On Body Delivery System (OBDS) - Sanofi-Aventis device used with isatuximab administration; abdominal/periumbilical single-site application with post-dose needle retraction and lock-out.

Sponsors & Collaborators

Principal Investigators

  • Clifton C. Mo, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2033-10-01
Completion
2038-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624513 on ClinicalTrials.gov