Multiple Myeloma, NeoplasmsNCT06924424
Aponermin, Pomalidomide, Dexamethasone for Patients With Relapsed/ Refractory Multiple Myeloma
A study testing Aponermin, pomalidomide, dexamethasone in people with Multiple Myeloma, Neoplasms, run by Peking University People's Hospital at 2 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Neoplasms
- What is being tested?
- Aponermin, pomalidomide, dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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
- Being tested
- Aponermin, pomalidomide, dexamethasone
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Apo-Pd for R/R MM | Experimental | Aponermin10mg/kg d1-5 ivgtt Pomalidomide 4mg d1-21 po Dex 20mg d1;d8;d15 po Receives: Drug: Aponermin, pomalidomide, dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response
Overall haematological response after 4 cycles of treatments
Measured: 4 months
Secondary outcomes (2)
PFS
Progression free survival, from initiation of Apo-Pd treatment to the occurrence of disease progression or death
Measured: 2 years
Adverse events
To determine safety of aponermin, pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma, NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924424
- Sponsor's protocol ID
- 2024-372-001
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aponermin, Pomalidomide, Dexamethasone for Patients With Relapsed/ Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06924424
- Acronym / sponsor ID
- 2024-372-001
- Conditions
- Multiple Myeloma, Neoplasms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apo-Pd for R/R MM | Experimental | Drug: Aponermin, pomalidomide, dexamethasoneAponermin10mg/kg d1-5 ivgtt Pomalidomide 4mg d1-21 po Dex 20mg d1;d8;d15 po |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aponermin, pomalidomide, dexamethasoneThree 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. | Drug | Apo-Pd for R/R MM |
Primary outcome
Overall Response
Time frame: 4 months
Overall haematological response after 4 cycles of treatments
2 secondary outcomes
PFS
Time frame: 2 years
Adverse events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aponermin, pomalidomide, dexamethasone in people with Multiple Myeloma, Neoplasms, run by Peking University People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.