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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

NCT06577025 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2030-09-02
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06577025 on ClinicalTrials.gov