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

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 \[V\]), imm

Trial Details

NCT ID

NCT07045909

Phase

PHASE2

Sponsor

PETHEMA Foundation

Status

RECRUITING

Cancer Type

Newly Diagnosed Multiple Myeloma

Interventions

Daratumumab
Isatuximab
Bortezomib
Lenalidomide
Cyclophosphamide
Fludarabine

Locations (sample)

Badalona, Spain|41.45004,2.24741
Barcelona, Spain|41.38879,2.15899
Madrid, Spain|40.4165,-3.70256
Madrid, Spain|40.4165,-3.70256
Pamplona, Spain|42.81687,-1.64323

Key Eligibility Criteria

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.
Measurable disease at screening per IMWG, defined as any of the following:

For full eligibility, visit ClinicalTrials.gov.

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