Study on AZD4045 for Treating Relapsed or Refractory Multiple Myeloma

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07681596

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, AZD4045, alone and in combination with other treatments, for adults with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of AZD4045, a new treatment for adults with relapsed or refractory multiple myeloma (RRMM). The study will test AZD4045 both on its own and in combination with other drugs, daratumumab and aldesleukin, to determine the best dose for future research.

Description

This study is designed to assess how safe and effective AZD4045 is for treating multiple myeloma that has come back or hasn't responded to other treatments. The study will also look at how the drug moves and works in the body. Participants will receive AZD4045 either by itself or with other medications, daratumumab and aldesleukin, to see how well it works and to find the best dose for future studies.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of multiple myeloma.
  • Must meet at least one of the following disease criteria:
    • Serum M-protein level of 1.0 g/dL or higher.
    • Urine M-protein of 200 mg/24 hours or higher.
    • Serum immunoglobulin free light chain of 10 mg/dL or higher and an abnormal kappa lambda ratio.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must provide a bone marrow sample for testing.
  • Must have adequate organ and bone marrow function.
  • Must have received at least three prior types of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
  • Must have evidence of disease progression based on specific criteria during or after the most recent treatment.

Exclusion Criteria

  • History of severe immune-related side effects from previous CAR-T cell therapy or similar treatments.
  • Ongoing side effects from previous cancer treatments that haven't improved, except for hair loss or mild nerve damage.
  • Known active or past involvement of the central nervous system by multiple myeloma.
  • Certain other blood disorders or conditions like amyloidosis or plasma cell leukemia.
  • History of other blood cancers, regardless of remission status.
  • History of other cancers unless disease-free for at least 2 years.
  • Significant neurological or psychiatric conditions.
  • Positive for HIV, chronic or active hepatitis B, or active hepatitis C.
  • Significant heart disease or conditions affecting heart function.
  • Any other serious medical condition that could interfere with treatment or evaluation.
  • Recent live vaccine, major surgery, or participation in another clinical study.
  • Known severe allergies to study drugs.
  • Recent treatment with CAR-T, CAR-NK, or BCMA-targeted therapies.
  • Recent stem cell transplant or radiation therapy.
  • Recent use of certain cancer treatments before starting the study.

Locations

FACILITYZIPCITYSTATE
Research Site91010DuarteCalifornia
Research Site80218DenverColorado
Research Site33612TampaFlorida
Research Site30322AtlantaGeorgia
Research Site63110St LouisMissouri
Research Site07601HackensackNew Jersey
Research Site44195ClevelandOhio
Research Site37203NashvilleTennessee
Research Site77030HoustonTexas
Research Site53226MilwaukeeWisconsin

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