Health Trials

Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)

ConditionsDe Novo Multiple MyelomaAnitocabtagene Autoleucel
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPETHEMA Foundation

About this trial

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 and B will receive lenalidomide maintenance therapy following infusion with anitocabtagene autoleucel.

Eligibility criteria

Qualifiers

Newly diagnosed Multiple Myeloma according to the IMWG criteria published in 2014.

For cohort A, patients will ≤ 70 years of age.

For the cohorts B and C, patients will be ≤ 80 years of age.

Serum M-protein level ≥ 1 g/dL or urine M-protein level ≥ 200 mg/24 hours; or

Disqualifiers

Active or prior history of central nervous system (CNS) or meningeal involvement of MM.

Cardiac atrial or cardiac ventricular MM involvement.

Diagnosis of primary amyloidosis (AL), monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia (PCL), active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or Waldenstrom's macroglobulinemia at the time of screening.

Localized skin cancer (melanoma and nonmelanoma) that has been completely resected and considered curative within the last 24 months is eligible.

Trial design

Treatments tested in this trial

  • Daratumumab
  • Isatuximab
  • Bortezomib
  • Lenalidomide
  • Cyclophosphamide
  • Fludarabine
  • Anitocabtagene Autoleucel

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators

PETHEMA Foundation

Lead sponsor

Source ClinicalTrials.gov