Relapsed or Refractory Multiple Myeloma (RRMM)Phase 1/2NCT06484829
Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing Purinostat Mesylate 4 mg/m2, Purinostat Mesylate 6 mg/m2 and Purinostat Mesylate 8.4 mg/m2 in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
Primary Purpose Phase Ib. To determine the Maximum Tolerated Dose (MTD) and establish the Recommended Phase IIa Dose (RP2D) of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed or refractory multiple myeloma. Phase IIa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Purinostat Mesylate 4 mg/m2, Purinostat Mesylate 6 mg/m2 and Purinostat Mesylate 8.4 mg/m2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2024to 1 Apr 2026
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with multiple myeloma (MM) by reference to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2022);
- Those who have received at least one line of prior systemic antimyeloma therapy (which must include lenalidomide and proteasome inhibitors; see Appendix 4 for counts of myeloma treatment lines) and meet the definition of relapse or refractory; Definition of relapse: disease progression that occurs at least 60 days from the last treatment after the efficacy of a prior treatment regimen was evaluated at MR or better (except for those who relapsed more than 1 year after treatment); Definition of refractory: progression during prior therapy or progression within 60 days of the last treatment; or failure to achieve MR or better after at least 2 prior courses of therapy; or treatment intolerance.
- Age 18-75 years, male or female, if of childbearing potential subjects should be on effective contraception and must agree to comply with all contraceptive requirements:
- 1) Females of childbearing potential must agree to and comply with the contraceptive measures specified in the protocol: beginning 4 weeks prior to treatment with this product, two reliable methods of contraception are required concurrently for the duration of the treatment, during the dose suspension, and for 4 weeks after termination of the treatment (one highly effective method of contraception-tubal ligation, intrauterine device, hormonal (contraceptive pills, injections, patches, vaginal rings, or implants), or partner's vasectomy, and another effective contraceptive method - male rubber or synthetic condom, diaphragm or cervical cap). Effective contraception is needed even with a history of infertility unless due to hysterectomy; 2) Men of childbearing potential must use a rubber or synthetic condom at all times during sexual contact with women of childbearing potential beginning 4 weeks prior to treatment with this product, during the treatment period, during the dose suspension period, and for 4 weeks after termination of treatment, even if they have had a successful vasectomy; 4. Subjects with multiple myeloma who have measurable M protein, i.e., at least one of the following 3 measurements:
- Serum M protein ≥ 0.5 g/dL (5 g/L);
- Urine M protein ≥ 200 mg/24h;
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- Serum free light chain assay: in the case of an abnormal serum free light chain ratio (less than 0.26 or greater than 1.65), an affected free light chain level ≥10mg/dL (100mg/L); 5. Hematologic fulfillment of the following conditions:
- 1) ANC ≥ 1.0 x 109/L (without granulocyte colony-stimulating factor within 7 days), with no specific requirement for neutrophil count when ≥ 50% of the bone marrow is plasma cells; 2) PLT ≥75 × 109/L (no platelet transfusion or use of thrombopoietin within 7 days), and platelets ≥50 × 109/L were eligible for enrollment when ≥50% of plasma cells were present in the bone marrow; 3) Hemoglobin ≥ 80 g/L (no red blood cell suspension infusion or use of erythropoietin within 7 days); 6. Liver and kidney function tests fulfill the following conditions:
- TBIL ≤ 1.5 x ULN;
- ALT and AST are ≤ 2.5 x ULN;
- Glomerular filtration rate (GFR) ≥ 30mL/min/1.73m2 (Cockcroft-Gault formula) without the effects of dialysis therapy; 7. Ability to receive and have access to antithrombotic medications such as low molecular heparin sodium, heparin, warfarin or aspirin; 8. An ECOG (Appendix 2) score of 0-2 and an expected survival of ≥12 weeks; 9. Subjects voluntarily enrolled in the study and signed an informed consent form.
Who cannot join
- Those with prior antitumor therapy with histone deacetylase (HDAC) inhibitors (except cedarbenazine), antibody-coupled degradation agents (DAC), HSP90 inhibitors, or valproic acid; or those who, in the judgment of the investigator, are intolerant to treatment with the same type of drug as HDAC inhibitors, pomalidomide, thalidomide, lenalidomide, or the like (e.g., grade ≥3 rash during prior use, severe refractory myelosuppression, etc.);
- Those with disease progression following prior treatment with standard dose pomalidomide;
- Allergic reactions to the components of the test drug involved in this trial;
- A diagnosis of non-secretory MM (defined as a subject who is completely non-secretory or who has a small amount of free light chain but the affected light chain is less than 100 mg/L), or MM in combination with amyloidosis, or plasma cell leukemia, either primary or during the course of therapy
- Those with active new thrombosis or who are unable to receive antithrombotic therapy;
- Other malignant tumors within 5 years prior to screening, with the exception of cured carcinoma in situ (e.g., cervix, breast, bladder, etc.), basal cell carcinoma of the skin, squamous epithelial cell carcinoma of the skin, or early-stage prostate carcinoma (with clinical staging of Tla or T1b);
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- Those who have a combination of central nervous system disorders and require treatment for such disorders
- Peripheral neuropathy ≥ grade 3; and
- Co-morbidities requiring long-term treatment with immunosuppressive drugs or steroids; 10. active infectious diseases;
- Those with comorbid active infectious diseases, including the following:
- 1) Hepatitis B Surface Antigen (HbsAg) or Hepatitis B Core Antibody (HbcAb) positive with HBV-DNA quantification higher than the upper limit of normal value 2) Positive Hepatitis C Virus Antibody (HCV-Ab) with HCV RNA quantification above the upper limit of normal; 3) Human immunodeficiency virus antibody (HIV-Ab) or anti-syphilis spirochete antibody (TP-Ab) positive; 11. Subjects with any of the following:
- Cardiac insufficiency ≥ grade 3 by NYHA classification (Appendix 1) criteria;
- Myocardial infarction within 6 months;
- Poorly controlled angina, including variant angina, within 6 months;
- Clinically significant arrhythmia;
- ECG QTcF >450 ms (men) and QTcF >470 ms (women) (Fridericia formula);
- Echocardiographic indication of left ventricular ejection fraction <50%; 12. A combination of severe infectious disease requiring systemic intravenous antibiotic therapy 2 weeks prior to the first dose; 13. Those who have received an allogeneic hematopoietic stem cell transplant within 12 months, or those who have active graft-versus-host disease (GVHD) or GVHD requiring immunosuppressive therapy more than 12 months after the allogeneic hematopoietic stem cell transplant; 14. Who have participated in another clinical trial within 4 weeks prior to the first dose; 15. Those who have received other antitumor therapy (including herbal antitumor therapy, except for ≤20 mg/day of prednisone and its equivalent dose of steroid hormones) within 2 weeks prior to the first administration of the drug; 16. Those who have not recovered to Grade 1 or below from toxic reactions to prior antitumor therapy (except alopecia, malaise and those limited by entry criteria #6); 17. Those who have received major surgical treatment within 4 weeks prior to the first dose and have not fully recovered; 18. Women who are pregnant or breastfeeding; 19. Persons who, in the opinion of the investigator, have other factors that make them unsuitable for participation in the trial (e.g., uncontrolled active hypertension, uncontrolled active diabetes mellitus, poor adherence, substance abuse, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610000
JingZe Zuo, 028-85422654, huaxilunli@163.com
About this study
Official title: An Open-Label, Parallel-Controlled, Multi-Center Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of Purinostat Mesylate for Injection Combined With Pomalidomide Capsules and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
Primary Purpose Phase Ib. To determine the Maximum Tolerated Dose (MTD) and establish the Recommended Phase IIa Dose (RP2D) of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed or refractory multiple myeloma.
Phase IIa. To further evaluate the safety and tolerability of Purinostat Mesylate for Injection at the RP2D combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM).
Read more
Secondary Objectives Phase Ib
- To evaluate the safety and tolerability of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in the treatment of relapsed or refractory multiple myeloma.
- To assess the pharmacokinetic (PK) parameters of the combination therapy in patients with relapsed or refractory multiple myeloma.
- To observe the preliminary efficacy of the combination therapy in patients with relapsed or refractory multiple myeloma.
Phase IIa
- To evaluate the preliminary efficacy of the combination therapy in patients with relapsed and refractory multiple myeloma (RRMM).
- To characterize the population pharmacokinetic (PPK) profile of the combination therapy in patients with relapsed or refractory multiple myeloma (RRMM).
- Being tested
- Purinostat Mesylate 4 mg/m2, Purinostat Mesylate 6 mg/m2, Purinostat Mesylate 8.4 mg/m2
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purinostat Mesylate 4 mg/m2Drug
4 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone.
Purinostat Mesylate 6 mg/m2Drug
6 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone.
Purinostat Mesylate 8.4 mg/m2Drug
8.4 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | A: Treatment Cycle Regimen - Regimen A (2-Week On/1-Week Off) - 21-Day Cycle
Purinostat Mesylate for Injection: Intravenous infusion on Days 1, 4, 8, and 11 of each 21-day (3-week) cycle during the Continuation Dosing Phase Ib and Phase IIa;
Pomalidomide Capsules: Oral administration once daily at 4 mg for 14 consecutive days followed by a 7-day rest period, with each cycle lasting 21 days (3 weeks);
Dexamethasone Acetate Tablets: 20 mg orally administered on Days 1, 4, 8, and 11 of each treatment cycle. Receives: Drug: Purinostat Mesylate 4 mg/m2; Drug: Purinostat Mesylate 6 mg/m2; Drug: Purinostat Mesylate 8.4 mg/m2 |
| B group | Experimental | B: Treatment Cycle Regimen - Regimen B (3-Week On/1-Week Off) - 28-Day Cycle
Purinostat Mesylate for Injection: Intravenous infusion on Days 1, 4, 15, and 18 of each 28-day (4-week) cycle during the Continuation Dosing Phase 1b and Phase IIa;
Pomalidomide Capsules: Oral administration once daily at 4 mg for 21 consecutive days followed by a 7-day rest period, with each cycle lasting 28 days (4 weeks);
Dexamethasone Acetate Tablets: 20 mg orally administered on Days 1, 4, 15,and 18 of each treatment cycle. Receives: Drug: Purinostat Mesylate 4 mg/m2; Drug: Purinostat Mesylate 6 mg/m2; Drug: Purinostat Mesylate 8.4 mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
One or more unacceptable toxic reactions following administration of the drug, resulting in the inability to continue increasing the dose or prolonging the dosing cycle
Measured: Day 21/Day 28
Maximum Tolerated Dose (MTD)
The maximum dose or concentration of a drug that does not cause death in experimental animals in experiments other than acute toxicity animal experiments (short-term repetitive experiments, subchronic toxicity experiments, chronic toxicity experiments).
Measured: Day 21/Day 28
Objective remission rate (ORR)
Defined as the proportion of subjects achieving a strict complete remission (sCR) + complete remission (CR) + very good partial remission (VGPR) + partial remission (PR);
Measured: Day 21/Day 28
Secondary outcomes (5)
Complete Remission Rate (CRR)
Proportion of subjects with sCR+CR
Measured: Day 21/Day 28
Duration of efficacy (DOR)
Duration of first remission (PR and above) to disease progression or death;
Measured: Day 21/Day 28
Time to Relief (TTR)
Time from first dose to PR and beyond
Measured: Day 21/Day 28
Progression-free survival (PFS)
Time from first dose to disease progression or death
Measured: Day 21/Day 28
Overall survival (OS)
Time from first dose to death from all causes
Measured: Day 21/Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start25 Mar 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ting Niu, Doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484829
- Sponsor's protocol ID
- ZLPM-002-1.0
- Status last verified
- Mar 2025
- First submitted
- 21 May 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel-Controlled, Multi-Center Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of Purinostat Mesylate for Injection Combined With Pomalidomide Capsules and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06484829
- Acronym / sponsor ID
- ZLPM-002-1.0
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
Primary Purpose Phase Ib. To determine the Maximum Tolerated Dose (MTD) and establish the Recommended Phase IIa Dose (RP2D) of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed or refractory multiple myeloma.
Phase IIa. To further evaluate the safety and tolerability of Purinostat Mesylate for Injection at the RP2D combined with fixed-dose Pomalidomide Capsules and Dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM).
Secondary Objectives Phase Ib
- To evaluate the safety and tolerability of Purinostat Mesylate for Injection combined with fixed-dose Pomalidomide Capsules and Dexamethasone in the treatment of relapsed or refractory multiple myeloma.
- To assess the pharmacokinetic (PK) parameters of the combination therapy in patients with relapsed or refractory multiple myeloma.
- To observe the preliminary efficacy of the combination therapy in patients with relapsed or refractory multiple myeloma.
Phase IIa
- To evaluate the preliminary efficacy of the combination therapy in patients with relapsed and refractory multiple myeloma (RRMM).
- To characterize the population pharmacokinetic (PPK) profile of the combination therapy in patients with relapsed or refractory multiple myeloma (RRMM).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: Purinostat Mesylate 4 mg/m2, Drug: Purinostat Mesylate 6 mg/m2, Drug: Purinostat Mesylate 8.4 mg/m2A: Treatment Cycle Regimen - Regimen A (2-Week On/1-Week Off) - 21-Day Cycle Purinostat Mesylate for Injection: Intravenous infusion on Days 1, 4, 8, and 11 of each 21-day (3-week) cycle during the Continuation Dosing Phase Ib and Phase IIa; Pomalidomide Capsules: Oral administration once daily at 4 mg for 14 consecutive days followed by a 7-day rest period, with each cycle lasting 21 days (3 weeks); Dexamethasone Acetate Tablets: 20 mg orally administered on Days 1, 4, 8, and 11 of each treatment cycle. |
| B group | Experimental | Drug: Purinostat Mesylate 4 mg/m2, Drug: Purinostat Mesylate 6 mg/m2, Drug: Purinostat Mesylate 8.4 mg/m2B: Treatment Cycle Regimen - Regimen B (3-Week On/1-Week Off) - 28-Day Cycle Purinostat Mesylate for Injection: Intravenous infusion on Days 1, 4, 15, and 18 of each 28-day (4-week) cycle during the Continuation Dosing Phase 1b and Phase IIa; Pomalidomide Capsules: Oral administration once daily at 4 mg for 21 consecutive days followed by a 7-day rest period, with each cycle lasting 28 days (4 weeks); Dexamethasone Acetate Tablets: 20 mg orally administered on Days 1, 4, 15,and 18 of each treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosed with multiple myeloma (MM) by reference to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2022);
- Those who have received at least one line of prior systemic antimyeloma therapy (which must include lenalidomide and proteasome inhibitors; see Appendix 4 for counts of myeloma treatment lines) and meet the definition of relapse or refractory; Definition of relapse: disease progression that occurs at least 60 days from the last treatment after the efficacy of a prior treatment regimen was evaluated at MR or better (except for those who relapsed more than 1 year after treatment); Definition of refractory: progression during prior therapy or progression within 60 days of the last treatment; or failure to achieve MR or better after at least 2 prior courses of therapy; or treatment intolerance.
- Age 18-75 years, male or female, if of childbearing potential subjects should be on effective contraception and must agree to comply with all contraceptive requirements:
- 1) Females of childbearing potential must agree to and comply with the contraceptive measures specified in the protocol: beginning 4 weeks prior to treatment with this product, two reliable methods of contraception are required concurrently for the duration of the treatment, during the dose suspension, and for 4 weeks after termination of the treatment (one highly effective method of contraception-tubal ligation, intrauterine device, hormonal (contraceptive pills, injections, patches, vaginal rings, or implants), or partner's vasectomy, and another effective contraceptive method - male rubber or synthetic condom, diaphragm or cervical cap). Effective contraception is needed even with a history of infertility unless due to hysterectomy; 2) Men of childbearing potential must use a rubber or synthetic condom at all times during sexual contact with women of childbearing potential beginning 4 weeks prior to treatment with this product, during the treatment period, during the dose suspension period, and for 4 weeks after termination of treatment, even if they have had a successful vasectomy; 4. Subjects with multiple myeloma who have measurable M protein, i.e., at least one of the following 3 measurements:
- Serum M protein ≥ 0.5 g/dL (5 g/L);
Key exclusion criteria (17 listed)
- Those with prior antitumor therapy with histone deacetylase (HDAC) inhibitors (except cedarbenazine), antibody-coupled degradation agents (DAC), HSP90 inhibitors, or valproic acid; or those who, in the judgment of the investigator, are intolerant to treatment with the same type of drug as HDAC inhibitors, pomalidomide, thalidomide, lenalidomide, or the like (e.g., grade ≥3 rash during prior use, severe refractory myelosuppression, etc.);
- Those with disease progression following prior treatment with standard dose pomalidomide;
- Allergic reactions to the components of the test drug involved in this trial;
- A diagnosis of non-secretory MM (defined as a subject who is completely non-secretory or who has a small amount of free light chain but the affected light chain is less than 100 mg/L), or MM in combination with amyloidosis, or plasma cell leukemia, either primary or during the course of therapy
- Those with active new thrombosis or who are unable to receive antithrombotic therapy;
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 |
|---|---|---|
| Purinostat Mesylate 4 mg/m24 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone. | Drug | A group, B group |
| Purinostat Mesylate 6 mg/m26 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone. | Drug | A group, B group |
| Purinostat Mesylate 8.4 mg/m28.4 mg/m2 Purinostat Mesylate + 4mg Pomalidomide + 20mg Dexamethasone. | Drug | A group, B group |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Day 21/Day 28
One or more unacceptable toxic reactions following administration of the drug, resulting in the inability to continue increasing the dose or prolonging the dosing cycle
Maximum Tolerated Dose (MTD)
Time frame: Day 21/Day 28
The maximum dose or concentration of a drug that does not cause death in experimental animals in experiments other than acute toxicity animal experiments (short-term repetitive experiments, subchronic toxicity experiments, chronic toxicity experiments).
Objective remission rate (ORR)
Time frame: Day 21/Day 28
Defined as the proportion of subjects achieving a strict complete remission (sCR) + complete remission (CR) + very good partial remission (VGPR) + partial remission (PR);
5 secondary outcomes
Complete Remission Rate (CRR)
Time frame: Day 21/Day 28
Duration of efficacy (DOR)
Time frame: Day 21/Day 28
Time to Relief (TTR)
Time frame: Day 21/Day 28
Progression-free survival (PFS)
Time frame: Day 21/Day 28
Overall survival (OS)
Time frame: Day 21/Day 28
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 2 Apr 2025.
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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.
Ting Niu, Doctor principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Purinostat Mesylate 4 mg/m2, Purinostat Mesylate 6 mg/m2 and Purinostat Mesylate 8.4 mg/m2 in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 2 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 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Liangkun Sun, bachelor (15885742617, liangkunsun@zenitar.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Day 21/Day 28). The study lists 3 primary outcomes in all. 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 2 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.