Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07764978

This Phase III study evaluates AZD0120's efficacy and safety in NDMM patients ineligible for ASCT. It compares IsaVRd/DRd induction followed by AZD0120 to continuous IsaRd/DRd therapy, focusing on progression-free survival and MRD-negative CR rate. Eligible participants are adults with measurable MM, ECOG 0-2, and adequate organ function. Interventions include AZD0120, daratumumab, dexamethasone, isatuximab, lenalidomide, bortezomib, cyclophosphamide, and fludarabine.

Patient Parameters

Program Overview

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.

Description

The primary objective is to demonstrate the superiority of IsaVRd or DRd induction followed by a single administration of AZD0120 compared to IsaVRd or DRd induction followed by continuous IsaRd or DRd in terms of progression-free survival (PFS) according to IMWG 2016 criteria, and as assessed by Blinded Independent Central Review (BICR) and miminal residual disease (MRD) negative complete response (CR) rate at 9 months post-randomisation in participants with NDMM who are ineligible to receive ASCT as initial therapy.

Eligibility Criteria

Inclusion Criteria

  1. Participants must be 18 years or older, at the time of signing the ICF.
  2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
  3. Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.
  4. Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
  5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
  6. ECOG performance status Grade of 0 to 2.
  7. Participant must have adequate organ and bone marrow function.

Exclusion Criteria

  1. Participant has active or prior CNS or meningeal involvement of MM.

  2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.

  3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.

  4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.

  5. Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.

  6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status.

  7. Participant is positive for any of the following:

    1. HIV: Known to be seropositive for HIV (including any history of HIV).
    2. Chronic or active hepatitis B.
    3. Active hepatitis C: Hepatitis C infection.
    4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations.

  8. Participant has clinically significant cardiovascular disease.

  9. Participant has COPD with an FEV1 < 50% of predicted normal.

  10. Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain.

Locations

FACILITYZIPCITYSTATE
Research Site85234GilbertArizona
Research Site85054PhoenixArizona
Research Site85719TucsonArizona
Research Site92868OrangeCalifornia
Research Site90404Santa MonicaCalifornia
Research Site80045AuroraColorado
Research Site80218DenverColorado
Research Site06510New HavenConnecticut
Research Site33156Coral GablesFlorida
Research Site33606TampaFlorida

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