Phase III Study Comparing AZD0120 and Stem Cell Transplant in Newly Diagnosed Multiple Myeloma Patients Eligible for Transplant

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07735637

This study is comparing the effectiveness of a new treatment, AZD0120, with the standard stem cell transplant in patients newly diagnosed with multiple myeloma who can undergo a transplant. The study will measure how long patients live without the disease getting worse and the rate of complete response without minimal residual disease at 9 months.

Patient Parameters

Program Overview

The study aims to compare the effectiveness of AZD0120 with the standard stem cell transplant in patients with newly diagnosed multiple myeloma who are eligible for a transplant. It will look at how long patients can live without the disease progressing and the rate of complete response at 9 months. The study will last up to 13 years, with participants in the AZD0120 group being followed for 15 years. Participants will receive either AZD0120 with maintenance treatment or undergo a stem cell transplant with maintenance treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of newly diagnosed multiple myeloma (NDMM).
  • Have measurable disease at diagnosis based on specific protein levels in blood or urine.
  • Completed 4 to 6 cycles of initial therapy with approved regimens like anti-CD38+VRd, DVTd, DRd, or VRd.
  • Achieved stable disease or better after initial therapy.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Eligible for high-dose melphalan treatment followed by a stem cell transplant.
  • Have adequate organ and bone marrow function.

Exclusion Criteria

  • Have or had cancer spread to the central nervous system or signs of brain involvement.
  • Have primary amyloidosis, active plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS syndrome.
  • Have significant neurological or psychiatric conditions.
  • Have a medical condition that poses a high risk for treatment complications.
  • Required additional therapy due to inadequate response to initial treatment.
  • Have had prior T-cell engager therapy, CAR-T, or CAR-NK cell therapy targeting any cancer.
  • Have had prior therapy targeting BCMA and CD19.

Locations

FACILITYZIPCITYSTATE
Research Site85234GilbertArizona
Research Site85338GoodyearArizona
Research Site85028PhoenixArizona
Research Site90095Los AngelesCalifornia
Research Site92868OrangeCalifornia
Research Site94110San FranciscoCalifornia
Research Site94305-5824StanfordCalifornia
Research Site80218DenverColorado
Research Site32224JacksonvilleFlorida
Research Site33612TampaFlorida

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