Who is eligible for clinical trial NCT07149857?

Participants must meet protocol criteria for Multiple Myeloma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07149857 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-27

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel (NCT07149857)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (5 items).

Location: University of California San Francisco — San Francisco, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (17 Sites)

University of California San Francisco — San Francisco, California
Moffitt Cancer Center — Tampa, Florida
University of Iowa Hospital and Clinics — Iowa City, Iowa
Memorial Sloan Kettering Cancer Center — New York, New York
Cleveland Clinic — Cleveland, Ohio
Royal Prince Alfred Hospital — Camperdown,
Austin Hospital — Heidelberg,
Fiona Stanley Hospital — Murdoch,
Princess Alexandra Hospital — Woolloongabba,
Hosp. Univ. Germans Trias I Pujol — Badalona,
Hosp Univ Vall D Hebron — Barcelona,
Hosp. Clinic de Barcelona — Barcelona,
Hosp. Univ. 12 de Octubre — Madrid,
Clinica Univ. de Navarra — Pamplona,
Hosp Clinico Univ de Salamanca — Salamanca,
Hosp. Univ. Marques de Valdecilla — Santander,
Hosp. Virgen Del Rocio — Seville,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗