Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Mult
The goal of this clinical trial is to learn if anitocabtagene autoleucel following induction therapy works to treat adult participants with newly diagnosed multiple myeloma. The main objectives of this clinical trial are: * To determine the incidence and severity of all adverse events (AEs). * To determine the proporti
| Condition(s) | De Novo Multiple Myeloma, Anitocabtagene Autoleucel |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to learn if anitocabtagene autoleucel following induction therapy works to treat adult participants with newly diagnosed multiple myeloma. The main objectives of this clinical trial are: * To determine the incidence and severity of all adverse events (AEs). * To determine the proportion of patients achieving undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10 to -5) at 12 months (+/- 3 months) after enrollment. Participants will receive induction therapy with a quadruplet regimen including a proteasome inhibitor (Bortezomib \[V\]), immunomodulatory drug (Lenalidomide \[R\]), dexamethasone \[d\] and anti-CD38 monoclonal antibody (Daratumumab \[D\] or Isatuximab \[Isa\]) followed by anitocabtagene autoleucel. Participants in Cohorts A |
| Who can participate | Inclusion Criteria: 1. Newly diagnosed Multiple Myeloma according to the IMWG criteria published in 2014. 1. For cohort A, patients will ≤ 70 years of age. 2. For the cohorts B and C, patients will be ≤ 80 years of age. 2. Measurable disease at screening per IMWG, defined as any of the following: 1. Serum M-protein level ≥ 1 g/dL or urine M-protein level ≥ 200 mg/24 hours; or 2. Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio. * Note: Local laboratory results may be used to establish measurable disease at screening if the results are ≥ 125% of requirements. 3. Only participants who are candidates to receive either D-VRd or Isa-VRd induction regimens, as determined by the investigator, should be con |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | PETHEMA Foundation |
| Locations | Badalona, Spain; Barcelona, Spain; Madrid, Spain; Madrid, Spain; Pamplona, Spain; Salamanca, Spain (+4 more sites) |
| Start date | 2025-06-30 |
| NCT ID | NCT07045909 |
| Official listing | https://clinicaltrials.gov/study/NCT07045909 |