Epunamin plus DECP for relapsed or refractory multiple myeloma
A Multicenter Real-World Study Evaluating Epunamin in Combination With a DECP-Based Regimen for Relapsed/Refractory Multiple Myeloma
This will test whether adding Epunamin to a DECP chemotherapy regimen helps people with relapsed or refractory multiple myeloma have better treatment responses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanxi Bethune Hospital Academic / other |
| Drugs / interventions | chemotherapy, Cyclophosphamide |
| Locations | 1 site (Taiyuan, Shanxi) |
| Trial ID | NCT07497165 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, single-arm real-world observational project enrolling 48 patients aged 18–75 with relapsed or refractory multiple myeloma who have had at least one prior systemic therapy. Participants with ECOG performance status 0–3 and adequate organ function will receive Epunamin combined with a DECP-based regimen and be followed for response and safety. The primary endpoint is overall response rate after four treatment cycles, with secondary endpoints including deeper response categories and safety/tolerability. Major exclusions include severe cardiac, pulmonary, hepatic or renal dysfunction, unresolved prior toxicities, significant peripheral neuropathy, active severe infection, plasma cell leukemia, recent other malignancy, HIV, pregnancy, or lactation.
Who should consider this trial
Good fit: Adults 18–75 years old with relapsed or refractory multiple myeloma by IMWG criteria who have received at least one prior systemic therapy, have ECOG 0–3, and meet organ function and consent requirements are ideal candidates.
Not a fit: Patients with severe organ dysfunction, unresolved prior treatment toxicities, grade ≥2 peripheral neuropathy, plasma cell leukemia, active severe infection, pregnancy, or recent other malignancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, the combination could increase response rates and offer an additional treatment option for patients with relapsed or refractory multiple myeloma.
How similar studies have performed: Combining novel agents with multiagent chemotherapy has produced benefits in some prior myeloma programs, but Epunamin itself appears novel and lacks large published trial evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adults aged 18 to 75 years with relapsed/refractory Multiple Myeloma diagnosed according to revised IMWG criteria. Received at least one prior systemic treatment regimen. Eastern Cooperative Oncology Group Performance Status score of 0-3. Able to understand treatment-related changes and management options during therapy and follow-up, with good treatment adherence and follow-up compliance. Provided written informed consent. - Exclusion Criteria: Severe dysfunction of major organs, including cardiac, pulmonary, hepatic, or renal impairment, defined as left ventricular ejection fraction \<50%, diffusion capacity for carbon monoxide \<50% of predicted value due to chronic respiratory disease, serum bilirubin \>2 mg/dL, alanine aminotransferase or aspartate aminotransferase \>2.5 × upper limit of normal, or estimated glomerular filtration rate \<30 mL/min. Toxicities from prior chemotherapy not recovered to baseline or grade ≤1. Peripheral neuropathy grade ≥2, or grade 1 with pain. Major surgery, radiotherapy, infection requiring systemic antibiotic treatment, or other severe infection within 14 days before enrollment. High-risk plasma cell leukemia with peripheral blood plasma cells ≥20%. Psychiatric disorders, cognitive impairment, or other conditions affecting self-control or study compliance. Pregnant or breastfeeding women, or fertile patients unwilling to use adequate contraception during the study. Male patients unwilling to use effective contraception or refrain from sperm donation during treatment and for 3 months after the last dose. Diagnosis or treatment of another malignancy within 2 years before enrollment. Known hypersensitivity to Epunamin, Dexamethasone, Cisplatin, Etoposide, or Cyclophosphamide. Human Immunodeficiency Virus Infection positive. Participation in another clinical trial within 30 days before enrollment or during the study period. Any condition considered unsuitable for participation by the investigator.
Where this trial is running
Taiyuan, Shanxi
- ShanxiBethuneH — Taiyuan, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Tian Weiwei Tian Weiwei, PhD
- Email: tianweiwei@yesh.net
- Phone: +156-13485304136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.