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

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

Conditions

• De Novo Multiple Myeloma
• Anitocabtagene Autoleucel

Interventions

DRUG

Daratumumab

Daratumumab will be administered by subcutaneous (SC) injection.

DRUG

Isatuximab

Isatuximab will be administered IV.

DRUG

Bortezomib

Bortezomib dose will be calculated using the patient's actual body surface area at baseline and will be administered by SC injection.

DRUG

Lenalidomide

Lenalidomide will be administered by oral route (all cohorts at induction, and cohorts A and B at maintenance).

DRUG

Cyclophosphamide

As part of lymphodepleting therapy before CAR-T manufacture, administered IV.

DRUG

Fludarabine

As part of lymphodepleting therapy before CAR-T manufacture, administered IV

DRUG

Anitocabtagene Autoleucel

Single infusion IV

Sponsors & Collaborators

• PETHEMA Foundation

  lead OTHER

Principal Investigators

• María Victoria Mateos, MD PhD · Hospital Universitario de Salamanca (Salamanca)

• Jesús San Miguel, Professor · Clínica Universidad de Navarra (Pamplona)

• Juan José Lahuerta, MD PhD · Hospital Universitario 12 de Octubre (Madrid)

• Joan Bladé, MD PhD · Hospital Clínic i Provincial de Barcelona (Barcelona)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2028-03-31

Completion

2030-03-31

FDA Drug

Yes

Countries

• Spain

Study Locations