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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma, Neoplasms
• Intervention / Treatment: Drug: Aponermin, pomalidomide, dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apo-Pd for R/R MM; Aponermin10mg/kg d1-5 ivgtt Pomalidomide 4mg d1-21 po Dex 20mg d1;d8;d15 po	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response	Overall haematological response after 4 cycles of treatments	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Pomalidomide
• Other Study ID Numbers: 2024-372-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No