Tests ciltacabtagene autoleucel in people with multiple myeloma
Tests cilta-cel, a cell therapy, with different preparation treatments in adults with multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Key facts
- Where
- Badalona, Barcelona, Madrid, Pamplona, Salamanca, Santander, and Sevilla, SpainSee the 8 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed multiple myeloma who cannot have high-dose chemotherapy with stem cell transplant and who responded to initial induction therapy.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Newly diagnosed multiple myeloma with measurable disease at diagnosis (M-protein in blood or urine, or high free light chains). Ongoing response of at least partial response (PR) to induction therapy.
- Earlier treatment
- Must have had at least 3 and no more than 5 cycles of induction therapy (DRd or VRd at first). Must not be a candidate for high-dose chemotherapy with stem cell transplant because of age, other health conditions, or refusing it.
- Biomarker or test result
- Serum M-protein 1.0 g/dL or more, or urine M-protein 200 mg/24 hours or more, or involved serum free light chain 10 mg/dL or more with an abnormal free light chain ratio.
Main reasons for not taking part
- Frailty index of 2 or more on the Myeloma Geriatric Assessment score
- Known allergy or intolerance to the study treatment or its active agents
- Ongoing grade 2 or higher non-blood side effects from induction therapy (grade 2 nerve damage from bortezomib is allowed)
- Needing continuous extra oxygen
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07149857, who can take part
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Clínica Universidad de navarraPamplona, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07149857EU 2025-521975-30-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel
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.
Inclusion: 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: Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib; Known allergies, hypersensitivity, or intolerance to study intervention or its active agents; Frailty index of >= 2 according to Myeloma Geriatric Assessment score; Participants who require continuous supplemental oxygen.