A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 80 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

ciltacabtagene autoleucel. A preparation of autologous T lymphocytes that are transduced, ex vivo, with LCAR-B38M, a lentiviral vector expressing a chimeric antigen receptor (CAR) containing two bispecific anti-B-cell maturation antigen (BCMA) variable fragments of llama heavy-chain murine antibodies fused to the signaling domain of 4-1BB (CD137), with potential immunostimulating and antineoplastic activities. The antigen-binding region of the CAR is a non-scFv structure targeting two distinct regions of BCMA. Upon intravenous administration back into the patient, ciltacabtagene autoleucel are directed to cells expressing BCMA, bind to two different epitopes on BCMA and induce selective toxicity in BCMA-expressing tumor cells. BCMA, a tumor-associated antigen (TAA) and a receptor for both a proliferation-inducing ligand (APRIL) and B-cell activating factor (BAFF), is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and plays a key role in plasma cell survival. BCMA is overexpressed on malignant plasma cells. NCI Drug Dictionary

Treatments listed in the registry

• Cilta-cel (Drug): Cilta-cel will be administered as intravenous infusion.
• Cyclophosphamide (Drug): Cyclophosphamide will be administered as intravenous infusion.
• Induction therapy (Drug): 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 (Drug): Fludarabine will be administered as intravenous infusion.

Na · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• leukapheresis: Part of the study plan

Main goals

• Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion (At least 12 months after Cilta-cel infusion on Day 1)

Other goals

• Overall MRD-negative CR Rate
• CR or better status
• Progression Free Survival (PFS)
• Overall Survival (OS)
• Number of Participants with Adverse Event (AE) by Severity
• Number of Participants with Abnormalities in Laboratory Parameters
• Levels of Cilta-cel T-Cell Expansion, and Persistence
• Number of Participants with Anti-Cilta-Cel Antibodies
• Percentage of Participants with Presence of Replication-competent Lentivirus (RCL)

Planned enrollment: 60 (estimated).

• University of California San Francisco, San Francisco, California
• Atrium Health, Charlotte, North Carolina
• Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center, Winston-Salem, North Carolina
• Cleveland Clinic, Cleveland, Ohio

13 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07149857
• NCI Drug Dictionary: C148498

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 24, 2026. Public record; not medical advice.