Actively Recruiting
A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
60
Participants Needed
17
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Documented diagnosis of newly diagnosed multiple myeloma with measurable disease at diagnosis
- Not eligible for high-dose chemotherapy with stem cell transplantation due to advanced age, comorbid conditions, or refusal
- Received at least 3 and no more than 5 cycles of induction therapy with DRd, VRd, or DVRd
- Achieved partial response or better on most recent disease assessment
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Willing and able to follow lifestyle restrictions in the protocol
You will not qualify if you...
- Frailty index of 2 or higher according to Myeloma Geriatric Assessment score
- Known allergies, hypersensitivity, or intolerance to study treatments or their active agents
- Grade 2 or higher ongoing non-hematologic toxicity from induction therapy, except grade 2 peripheral neuropathy due to bortezomib
- Requirement for continuous supplemental oxygen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
3
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
5
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
Royal Prince Alfred Hospital
Camperdown, Australia, 2050
Actively Recruiting
7
Austin Hospital
Heidelberg, Australia, 3084
Actively Recruiting
8
Fiona Stanley Hospital
Murdoch, Australia, 6150
Actively Recruiting
9
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Actively Recruiting
10
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
11
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
12
Hosp. Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
13
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
14
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Actively Recruiting
15
Hosp Clinico Univ de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
16
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
17
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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