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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Daratumumab

    Drug

    Daratumumab will be administered by subcutaneous (SC) injection.

  • Isatuximab

    Drug

    Isatuximab will be administered IV.

  • Bortezomib

    Drug

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

  • Lenalidomide

    Drug

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

  • Cyclophosphamide

    Drug

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

  • Fludarabine

    Drug

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

  • Anitocabtagene Autoleucel

    Drug

    Single infusion IV

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Cohort AExperimental treatment 6 interventions
Group B: Cohort BExperimental treatment 6 interventions
Group C: Cohort CExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of all adverse events (AEs)

To characterize the safety of anitocabtagene autoleucel following induction therapy (incidence of treatment-emergent adverse events).

Time frame
3 years
2

Undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10-5) at 12 months (+/- 3 months) after enrollment.

To further characterize the efficacy profile of anitocabtagene autoleucel following induction therapy. MRD measured by Next Generation Flow Cytometry (NGF, with a sensitivity level of 10-6).

Time frame
12 months

Secondary outcomes

1

Undetectable minimal residual disease (MRD) negative CR rate (minimum 10-5) at 2, 6, 12, 18 and 24 months after CAR T infusion and sustained undetectable minimal residual disease (uMRD) annually.

To further characterize the efficacy profile of anitocabtagene autoleucel following induction therapy. MRD measured by Next Generation Flow Cytometry.

Time frame
2 years
2

Stringent complete response (sCR) or complete response (CR) rate, as assessed by investigators according to the International Myeloma Working Group (IMWG) criteria.

CR measured by cytomorphplogy and flow cytometry.

Time frame
6 months
3

Overall MRD negativity (minimum 10e-5)

MRD measured by Next Generation Flow Cytometry.

Time frame
3 years
4

Rate of conversion from undetectable to detectable MRD as well as biochemical progression rate.

MRD measured by Next Generation Flow Cytometry. Biochemical progression by measuring serum and/or urine monoclonal protein alone or with clinical features suggestive of progression including CRAB (C, hypercalcemia; R, renal failure; A, anemia; B, bone disease) symptoms.

Time frame
3 years

Other outcomes

Sponsors and contacts

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PETHEMA Foundation

Lead sponsor

Source ClinicalTrials.gov
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