Epunamin plus DECP for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ShanxiBethuneH
  Taiyuan, Shanxi, China Recruiting

Study contacts

• Study coordinator: Tian Weiwei Tian Weiwei, PhD
• Email: tianweiwei@yesh.net
• Phone: +156-13485304136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.