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NCT07149857PHASE2Recruiting

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Janssen Research & Development, LLC

Start Date

10/3/2025

Completion Date

4/6/2029

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 Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

Cilta-cel

DRUG

Cyclophosphamide

DRUG

Induction therapy

DRUG

Fludarabine

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Conditions

Multiple Myeloma

Locations

University of California San Francisco

San Francisco, California 94143

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

University of Iowa Hospital and Clinics

Iowa City, Iowa 52242

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Royal Prince Alfred Hospital

Camperdown, 2050

Australia

Austin Hospital

Heidelberg, 3084

Australia

Fiona Stanley Hospital

Murdoch, 6150

Australia

Princess Alexandra Hospital

Woolloongabba, 4102

Australia

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916

Spain

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp. Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Clinica Univ. de Navarra

Pamplona, 31008

Spain

Hosp Clinico Univ de Salamanca

Salamanca, 37007

Spain

Hosp. Univ. Marques de Valdecilla

Santander, 39008

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain