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ACTIVE NOT RECRUITING
NCT06577025
PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2024-08-20

Completion Date

2030-09-02

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

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.

Locations (16)

City of Hope

Duarte, California, United States

University of California San Francisco

San Francisco, California, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Peter MacCallum Cancer Centre

Melbourne, Australia

The Alfred Hospital

Melbourne, Australia

Instituto D Or de Pesquisa e Ensino

Salvador, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Universitatsklinikum Wurzburg

Würzburg, Germany

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain