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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06550895
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cilta-cel — DRUG
    Cilta-cel infusion will be administered intravenously.
  • Talquetamab — DRUG
    Talquetamab will be administered subcutaneously.

Study Details

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).

Key Dates

Start date
Sep 16, 2024
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 26, 2027

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy
    Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.

Primary Outcome Measure

Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [ Time Frame: Up to 3 years and 5 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Norton Cancer InstituteLouisvilleKentucky40207-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Iowa City, IA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Iowa Hospital and Clinics· Iowa City, IANorton Cancer Institute· Louisville, KYBarbara Ann Karmanos Cancer Institute· Detroit, MIIcahn School of Medicine at Mount Sinai· New York, NYUniversity of Pennsylvania· Philadelphia, PA

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