A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Condition(s) studied
Investigational drug(s) / intervention(s)
Cilta-cel: Cilta-cel will be administered as intravenous infusion.
Cyclophosphamide: Cyclophosphamide will be administered as intravenous infusion.
Induction therapy: Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd), will will be administered.
Fludarabine: Fludarabine will be administered as intravenous infusion.
Study summary
The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.
Eligibility
Primary outcome measure(s)
- Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion — At least 12 months after Cilta-cel infusion on Day 1
Participants in CR or better who achieve MRD-negative status at 12 months after cilta-cel infusion with a sensitivity of 10\^-5, prior to progressive disease (PD) or subsequent anti-myeloma therapy will be reported.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Francisco | San Francisco | California | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Active Not Recruiting |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | Active Not Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Active Not Recruiting |
| Atrium Health | Charlotte | North Carolina | Recruiting |
| Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center | Winston-Salem | North Carolina | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Royal Prince Alfred Hospital | Camperdown | Australia | Recruiting |
| Monash Medical Centre | Clayton | Australia | Recruiting |
| Austin Hospital | Heidelberg | Australia | Recruiting |
| Fiona Stanley Hospital | Murdoch | Australia | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Australia | Recruiting |
| Hosp. Univ. Germans Trias I Pujol | Badalona | Spain | Recruiting |
| Hosp Univ Vall D Hebron | Barcelona | Spain | Recruiting |
| Hosp. Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hosp. Univ. 12 de Octubre | Madrid | Spain | Recruiting |
| Clinica Univ. de Navarra | Pamplona | Spain | Recruiting |
| Hosp Clinico Univ de Salamanca | Salamanca | Spain | Recruiting |
| Hosp. Univ. Marques de Valdecilla | Santander | Spain | Recruiting |
| Hosp. Virgen Del Rocio | Seville | Spain | Recruiting |
More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07149857 on ClinicalTrials.gov ↗ ← All trials in Spain