Study on AZD0120 for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Stem Cell Transplant
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07764978
This clinical trial is testing a new treatment approach for patients with newly diagnosed multiple myeloma who cannot undergo a stem cell transplant. The study compares the effectiveness and safety of standard treatments followed by the new drug AZD0120 against standard treatments alone.
Patient Parameters
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Program Overview
The purpose of this study is to see if adding a new drug, AZD0120, to standard treatment regimens can help patients with newly diagnosed multiple myeloma live longer without their disease getting worse. The study focuses on patients who are not eligible for a stem cell transplant. Researchers will compare the outcomes of patients receiving standard treatments followed by AZD0120 to those receiving standard treatments alone, looking at how long patients remain free from disease progression and how many achieve a complete response with no minimal residual disease.
Description
This study is designed to evaluate whether adding AZD0120 to standard induction treatments (IsaVRd or DRd) can improve outcomes for patients with newly diagnosed multiple myeloma who are not eligible for a stem cell transplant. The main goal is to see if this approach can extend the time patients live without their disease worsening and increase the rate of complete responses without minimal residual disease at 9 months after starting treatment. Participants will be randomly assigned to receive either the standard treatment followed by AZD0120 or the standard treatment alone. The study will assess the safety and effectiveness of these treatments through regular health checks and evaluations.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of multiple myeloma.
- Must have measurable disease based on specific protein levels in the blood or urine.
- Must be ineligible for a stem cell transplant but have adequate organ function for CAR-T cell treatment.
- Must be suitable for at least one of the standard treatment regimens (IsaVRd or DRd).
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must have adequate organ and bone marrow function.
Exclusion Criteria
- Have active or previous involvement of the central nervous system by multiple myeloma.
- Have other specific blood disorders like primary amyloidosis or plasma cell leukemia.
- Have significant neurological or psychiatric conditions that pose a risk.
- Have any other serious medical conditions that increase risk or interfere with treatment.
- Have a history of other cancers unless disease-free for at least 2 years.
- Have a history of other blood cancers besides multiple myeloma.
- Test positive for HIV, hepatitis B, or active hepatitis C.
- Have significant heart disease.
- Have chronic obstructive pulmonary disease (COPD) with low lung function.
- For those receiving IsaVRd: Have severe peripheral neuropathy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85234 | Gilbert | Arizona |
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 85719 | Tucson | Arizona |
| Research Site | 92868 | Orange | California |
| Research Site | 90404 | Santa Monica | California |
| Research Site | 80045 | Aurora | Colorado |
| Research Site | 80218 | Denver | Colorado |
| Research Site | 06510 | New Haven | Connecticut |
| Research Site | 33156 | Coral Gables | Florida |
| Research Site | 33606 | Tampa | Florida |
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