NCT06924424

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Mar 2025Jun 2027

Study Start

First participant enrolled

March 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

April 6, 2025

Last Update Submit

April 6, 2025

Conditions

Multiple Myeloma, Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Overall Response

    Overall haematological response after 4 cycles of treatments

    4 months

Secondary Outcomes (2)

  • PFS

    2 years

  • Adverse events

    2 years

Study Arms (1)

Apo-Pd for R/R MM

EXPERIMENTAL

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

Drug: Aponermin, pomalidomide, dexamethasone

Interventions

Aponermin, pomalidomide, dexamethasoneDRUG

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.

Apo-Pd for R/R MM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms

Interventions

pomalidomideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 6, 2025

First Posted

April 11, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)