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Active, Not Recruiting

NCT Number: NCT06924424

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Aponermin, pomalidomide, dexamethasone

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.

Primary outcomes

  1. Overall Response

    Time frame: 4 months

    Overall haematological response after 4 cycles of treatments

Secondary outcomes

  1. PFS

    Time frame: 2 years

    Progression free survival, from initiation of Apo-Pd treatment to the occurrence of disease progression or death

  2. Adverse events

    Time frame: 2 years

    To determine safety of aponermin, pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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