NCT06577025

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete response/stringent complete response (CR/sCR) and a positron emission tomography/computed tomography (PET/CT) scan that does not show any signs of cancer at 5 years. MRD negativity and CR/sCR is defined as no detectable signs of remaining cancer cells after the treatment. This study will also characterize how well the treatments administered work in the study through progression-free survival (PFS). PFS is defined as the length of time during and after the treatment of a disease, that a participant lives with the disease, but it does not get worse.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cilta-cel	Cilta-cel infusion will be administered intravenously.
DRUG	Talquetamab	Talquetamab will be administered subcutaneously.
DRUG	Daratumumab	Daratumumab will be administered subcutaneously as a part of DVRd induction and Tal-D or Tec-D consolidation.
DRUG	Teclistamab	Teclistamab will be administered subcutaneously.
DRUG	Bortezomib	Bortezomib will be administered subcutaneously as a part of induction.
DRUG	Lenalidomide	Lenalidomide will be administered orally as a part of induction.
DRUG	Dexamethasone	Dexamethasone will be administered orally as a part of induction.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered intravenously as a part of conditioning regimen.
DRUG	Fludarabine	Fludarabine will be administered intravenously as a part of conditioning regimen.

Timeline

• Start date: 2024-08-20
• Primary completion: 2030-07-31
• Completion: 2030-09-02
• First posted: 2024-08-29
• Last updated: 2026-04-13

Locations

16 sites across 5 countries: United States, Australia, Brazil, Germany, Spain

Regulatory

• FDA-regulated drug study