NCT05257083

A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 759 (actual)
• Sponsor: Stichting European Myeloma Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

Detailed description

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel \[cilta-cel\]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT). Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	Daratumumab will be administered SC.
DRUG	Bortezomib	Bortezomib will be administered SC.
DRUG	Lenalidomide	Lenalidomide will be administered orally.
DRUG	Dexamethasone	Dexamethasone will be administered orally.
DRUG	Cilta-cel	Cilta-cel will be administered intravenously
DRUG	Cyclophosphamide	Cyclophosphamide will be administered intravenously.
DRUG	Fludarabine	Fludarabine will be administered intravenously.

Timeline

• Start date: 2023-10-10
• Primary completion: 2033-06-01
• Completion: 2040-08-01
• First posted: 2022-02-25
• Last updated: 2026-03-17

Locations

106 sites across 16 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Greece, Israel, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study