A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Phase 2RecruitingNCT07149857

Janssen Research & Development, LLC60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

Cilta-celDRUG

Cilta-cel will be administered as intravenous infusion.

CyclophosphamideDRUG

Cyclophosphamide will be administered as intravenous infusion.

Induction therapyDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (20)

University of California San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion

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.

Time frame: At least 12 months after Cilta-cel infusion on Day 1

Secondary Outcomes

Overall MRD-negative CR Rate

Overall MRD-negative CR is defined as the percentage of participants who achieve MRD-negative CR with a sensitivity of 10\^-5 at any time after enrollment but prior to PD or subsequent anti-myeloma therapy.

Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

CR or better status

CR or better is defined as the percentage of participants who achieve a CR or stringent complete response (sCR) according to the most recent international myeloma working group (IMWG) criteria.

Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

Progression Free Survival (PFS)

PFS is defined as the time from the date of enrollment to the date of first documented PD, as defined in the most recent IMWG criteria, or death due to any cause, whichever occurs first.

Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

Overall Survival (OS)

OS is measured from the date of enrollment to the date of the participant's death.

Time frame: Up to 3 years and 4 months

Number of Participants with Adverse Event (AE) by Severity

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

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