Phase III Study Comparing AZD0120 and Stem Cell Transplant in Newly Diagnosed Multiple Myeloma Patients Eligible for Transplant
Sponsor: AstraZeneca
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
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85234 | Gilbert | Arizona |
| Research Site | 85338 | Goodyear | Arizona |
| Research Site | 85028 | Phoenix | Arizona |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 92868 | Orange | California |
| Research Site | 94110 | San Francisco | California |
| Research Site | 94305-5824 | Stanford | California |
| Research Site | 80218 | Denver | Colorado |
| Research Site | 32224 | Jacksonville | Florida |
| Research Site | 33612 | Tampa | Florida |
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