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NOT YET RECRUITING
NCT07903272
PHASE3

A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare how well Ramantamig plus Daratumumab (ramantamig-D) works compared with a treatment that includes Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd), followed by high-dose therapy, autologous stem cell transplantation (using the participant's own stem cells), and maintenance treatment with Daratumumab and Lenalidomide (DR) in participants with newly diagnosed multiple myeloma (NDMM), a blood cancer affecting plasma cells, who are eligible for transplant.

Official title: A Phase 3 Randomized Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) and Daratumumab and Lenalidomide (DR) Maintenance (DVRd + High-dose Therapy [HDT] + ASCT + DR) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2026-12-14

Completion Date

2037-01-11

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Ramantamig

Ramantamig will be administered as subcutaneous (SC) injection.

DRUG

Daratumumab

Daratumumab will be administered as SC injection.

DRUG

Bortezomib

Bortezomib will be administered as SC injection.

DRUG

Lenalidomide

Lenalidomide will be administered orally.

DRUG

Dexamethasone

Dexamethasone will be administered orally or intravenously (IV).

DRUG

HDT+ASCT

HDT and ASCT will be performed as per standard of care.