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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria
* Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (\>=)1.0 grams per deciliter (g/dL) or urine M-protein level \>= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain \>= 10 mg/dL and abnormal serum free light chain ratio
* Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment
* Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved \>= partial response (PR) on the most recent disease assessment to be enrolled
* Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1
* Must be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria
* Frailty index of \>= 2 according to Myeloma Geriatric Assessment score
* Known allergies, hypersensitivity, or intolerance to study intervention or its active agents
* Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib
* Participants who require continuous supplemental oxygen
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 (17)
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
Cleveland Clinic
Cleveland
Ohio
Recruiting
Royal Prince Alfred Hospital
Camperdown
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 the USA
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.
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