A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Description

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

Conditions

Multiple Myeloma

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Study Overview

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Study Details

Study overview

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa Hospital and Clinics, Iowa City, Iowa, United States, 52242

Louisville

Norton Cancer Institute, Louisville, Kentucky, United States, 40207

Detroit

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Milwaukee

Medical College Of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
  • * Cohorts 1 and 3: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy. Cohort 2: Be newly diagnosed MM and considered ineligible for high-dose chemotherapy with autologous stem cell transplant (ASCT)
  • * Cohorts 1 and 3: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
  • * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • * Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening
  • * Cohorts 1 and 3: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy. Cohort 2: Received any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
  • * Cohorts 1 and 3: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment
  • * Cohort 2: Received a strong cytochrome P450 (CYP450) inducer within 5 half-lives prior to daratumumab, lenalidomide and dexamethasone (DRd) induction therapy
  • * Receive live, attenuated vaccine within 4 weeks of enrollment
  • * Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2027-02-15