Aponermin, Pomalidomide, Dexamethasone for Patients With Relapsed/ Refractory Multiple Myeloma

Not Applicable

Active, not recruiting

• Conditions: Multiple Myeloma, Neoplasms
• Interventions: Drug: Aponermin, pomalidomide, dexamethasone

• Registration Number: NCT06924424
• Lead Sponsor: Peking University People's Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-06
• Study First Submitted QC: 2025-04-06
• Last Update Submitted: 2025-04-06
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. RRMM patients who have received 1-3 line treatment;
2. Age above 18 years old, male or female not limited;
3. ECOG score ≤ 2;
4. Expected survival period is greater than 3 months;
5. 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;
6. The patient understands the purpose and steps of this trial, voluntarily participates in this trial, and signs a written informed consent form.

Exclusion Criteria

1. Allergic or intolerant to the investigational drug or its components;
2. Received any experimental drug treatment within 4 weeks;
3. Simultaneously suffering from other tumors, or having undergone anti-tumor treatment (including major surgery) in the past 4 weeks;
4. 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;
5. Suffering from mental illness;
6. Accompanied by severe lung infection, skin and soft tissue infection, or urinary tract infection;
7. There was a serious thrombotic event before treatment;
8. Unable or unwilling to receive prophylactic antithrombotic therapy;
9. Serious, uncontrolled medical disorders or active infections;
10. Researchers determine situations that are not suitable for inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apo-Pd for R/R MM	Aponermin, pomalidomide, dexamethasone	Aponermin10mg/kg d1-5 ivgtt Pomalidomide 4mg d1-21 po Dex 20mg d1;d8;d15 po

Primary Outcome Measures

Name	Time	Method
Overall Response	4 months	Overall haematological response after 4 cycles of treatments

Secondary Outcome Measures

Name	Time	Method
PFS	2 years	Progression free survival, from initiation of Apo-Pd treatment to the occurrence of disease progression or death
Adverse events	2 years	To determine safety of aponermin, pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China