Status:
ACTIVE_NOT_RECRUITING
Aponermin, Pomalidomide, Dexamethasone for Patients With Relapsed/ Refractory Multiple Myeloma
Lead Sponsor:
Peking University People's Hospital
Conditions:
Multiple Myeloma, Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to evaluate the efficacy and safety of a three drug combination therapy of aponermin, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple myeloma
Eligibility Criteria
Inclusion
- RRMM patients who have received 1-3 line treatment;
- Age above 18 years old, male or female not limited;
- ECOG score ≤ 2;
- Expected survival period is greater than 3 months;
- For female patients, (1) they have been menopausal for at least 24 months before the screening visit, or have undergone surgical contraception; (2) Women with fertility must have two negative urine HCG pregnancy tests within 72 hours before starting to take the study drug; For male patients must agree to absolute abstinence or effective barrier contraception throughout the entire study treatment period until 28 days after the last study drug treatment, and have no sperm donation behavior;
- The patient understands the purpose and steps of this trial, voluntarily participates in this trial, and signs a written informed consent form.
Exclusion
- Allergic or intolerant to the investigational drug or its components;
- Received any experimental drug treatment within 4 weeks;
- Simultaneously suffering from other tumors, or having undergone anti-tumor treatment (including major surgery) in the past 4 weeks;
- Currently, there are poorly controlled heart diseases, such as heart function grade III or IV (NYAH classification),uncontrolled atrial fibrillation, unstable angina, and myocardial infarction within the 12 months prior to enrollment;
- Suffering from mental illness;
- Accompanied by severe lung infection, skin and soft tissue infection, or urinary tract infection;
- There was a serious thrombotic event before treatment;
- Unable or unwilling to receive prophylactic antithrombotic therapy;
- Serious, uncontrolled medical disorders or active infections;
- Researchers determine situations that are not suitable for inclusion.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06924424
Start Date
March 1 2025
End Date
June 30 2027
Last Update
April 11 2025
Active Locations (2)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Henan Cancer Hospital
Zhengzhou, Henan, China