Study on APG-2575 Combined with New Treatments for Patients with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Ascentage Pharma Group Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04942067

Provider View

This clinical trial is testing a new drug, APG-2575, combined with other treatments to see if it is safe and effective for patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a new drug, APG-2575, when used with other treatments in patients with multiple myeloma that has come back or is not responding to treatment. The study will have two parts: one to find the best dose and another to see how well it works. Patients will receive APG-2575 along with other medications in cycles, and researchers will monitor their health and response to the treatment.

Description

This clinical trial is testing a new drug called APG-2575 in combination with other treatments for patients with multiple myeloma that has returned or is not responding to treatment. The study has two parts: finding the best dose and seeing how well the treatment works.

In one part of the study, patients will receive APG-2575 with other drugs, pomalidomide and dexamethasone, to find the highest dose that can be safely given. The treatment will be given in cycles, with APG-2575 taken daily and the other drugs taken on specific days of a 28-day cycle.

Researchers will start with a lower dose of APG-2575 and gradually increase it in different groups of patients to find the best dose that is both safe and effective. They will closely monitor patients for any side effects and adjust the dose as needed.

The goal is to determine the most effective dose of APG-2575 when combined with other treatments and to see if this combination can help control multiple myeloma in patients whose disease has returned or is not responding to other treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have relapsed or refractory multiple myeloma, meaning the disease has returned or not responded to previous treatments.
  • Have been treated with at least one but no more than four previous therapies for multiple myeloma.
  • Have measurable disease based on specific medical tests.
  • Be in good overall health with a life expectancy of at least 6 months.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women must not be pregnant and must agree to use effective birth control during the study.
  • Men and women must agree to use effective birth control during the study and for 90 days after the last dose.
  • Be able to complete questionnaires with or without assistance (for AL amyloidosis patients only).

Exclusion Criteria

  • Have newly diagnosed multiple myeloma or have not received any treatment for it.
  • Have received cancer treatment within 2 weeks before starting the study.
  • Have had a stem cell transplant from a donor.
  • Plan to have a stem cell transplant during the study.
  • Have received BCL-2-directed therapy within 4 weeks before starting the study.
  • Have intolerance to pomalidomide, daratumumab, or lenalidomide.
  • Have uncontrolled active infections, including hepatitis B or C, or HIV.
  • Have severe nerve damage not caused by AL amyloidosis.
  • Have certain other blood disorders or conditions.
  • Have had major surgery or radiation therapy within 14 days before starting the study.
  • Have had a recent infection requiring treatment within 14 days before starting the study.
  • Have received live vaccines within 4 weeks before starting the study.
  • Have another active cancer within the past year, except for certain skin cancers or carcinoma in situ.
  • Require treatment with certain strong medications.
  • Have known bleeding disorders or a history of stroke or brain bleeding within 6 months before starting the study.
  • Have any other condition that would make participation in the study unsuitable.

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