A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
• Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy
• Cohort 1: 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
Locations
United States
Iowa
University of Iowa Hospital and Clinics
RECRUITING
Iowa City
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Michigan
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
SUSPENDED
New York
Pennsylvania
Thomas Jefferson University
SUSPENDED
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Wisconsin
Medical College Of Wisconsin
SUSPENDED
Milwaukee
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Austin Hospital
RECRUITING
Heidelberg
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2024-09-16
Estimated Completion Date:2026-11-30
Participants
Target number of participants:10
Treatments
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.