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

NCT ID: NCT06924424

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-06-30

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

Conditions

Multiple Myeloma, Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apo-Pd for R/R MM

Aponermin10mg/kg d1-5 ivgtt Pomalidomide 4mg d1-21 po Dex 20mg d1;d8;d15 po

Group Type: EXPERIMENTAL

Aponermin, pomalidomide, dexamethasone

Intervention Type: DRUG

Three drugs combination for R/R MM. Aponermin, 10mg/kg d1-5 Pomalidomide 4mg d1-21 Dexamethasone 20mg d1,d8,d15 Each treatment cycle is 28 days.

Interventions

Aponermin, pomalidomide, dexamethasone

Three drugs combination for R/R MM. Aponermin, 10mg/kg d1-5 Pomalidomide 4mg d1-21 Dexamethasone 20mg d1,d8,d15 Each treatment cycle is 28 days.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Lu, MD

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

2024-372-001

Identifier Type: -

Identifier Source: org_study_id