Actively Recruiting
Epunamin Combined With DECP for Relapsed/Refractory Multiple Myeloma
Led by Shanxi Bethune Hospital · Updated on 2026-03-27
48
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Multiple Myeloma remains an incurable hematologic malignancy, and outcomes for relapsed/refractory multiple myeloma (RRMM) remain unsatisfactory despite advances in therapy. This study aims to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in a real-world clinical setting. Methods: This multicenter, single-arm, real-world observational study will enroll 48 patients aged 18-75 years with RRMM diagnosed according to revised IMWG criteria who have received at least one prior systemic treatment. Eligible patients must have an ECOG performance status of 0-3, adequate treatment compliance, and written informed consent. Key exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved prior treatment toxicity above grade 1; grade ≥2 peripheral neuropathy or grade 1 with pain; severe infection within 14 days; plasma cell leukemia; psychiatric disorders affecting compliance; pregnancy or lactation; recent other malignancies; hypersensitivity to study drugs; HIV infection; participation in another clinical trial within 30 days; or any condition deemed unsuitable by investigators. Endpoints: The primary endpoint is overall response rate (ORR) after four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), assessed according to revised IMWG criteria. Statistical Analysis: Continuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Normally distributed data will be analyzed using Student's t-test or ANOVA, while non-normally distributed data will use rank-sum tests. Categorical variables will be analyzed using chi-square or Fisher's exact tests, and ordinal variables by Ridit analysis or nonparametric tests. Survival outcomes including progression-free survival (PFS) and overall survival (OS) will be estimated using Kaplan-Meier analysis and compared by log-rank test. A two-sided P value \<0.05 will be considered statistically significant. Study Period: October 2025 to September 2027.
CONDITIONS
Official Title
Epunamin Combined With DECP for Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years with relapsed/refractory Multiple Myeloma diagnosed by revised IMWG criteria
- Have received at least one prior systemic treatment regimen
- Eastern Cooperative Oncology Group Performance Status score of 0 to 3
- Able to understand treatment changes and manage therapy and follow-up with good adherence
- Provided written informed consent
You will not qualify if you...
- Severe cardiac, pulmonary, hepatic, or renal dysfunction (e.g., left ventricular ejection fraction <50%, severe chronic respiratory disease, high liver enzymes, or low kidney function)
- Unresolved toxicities from prior chemotherapy above grade 1
- Peripheral neuropathy grade 2 or higher, or grade 1 with pain
- Major surgery, radiotherapy, or severe infection requiring antibiotics within 14 days before enrollment
- High-risk plasma cell leukemia with ≥20% plasma cells in blood
- Psychiatric disorders or cognitive impairments affecting compliance
- Pregnant or breastfeeding women, or patients unwilling to use contraception
- Diagnosis or treatment of another malignancy within 2 years before enrollment
- Known allergies to study drugs (Epunamin, Dexamethasone, Cisplatin, Etoposide, Cyclophosphamide)
- HIV positive
- Participation in another clinical trial within 30 days before or during the study
- Any condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
ShanxiBethuneH
Taiyuan, Shanxi, China, 030000
Actively Recruiting
Research Team
T
Tian Weiwei Tian Weiwei, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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