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Epunamin Combined With DECP for Relapsed/Refractory Multiple Myeloma 48 Evidencia mundo real Observacional Supervivencia global
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...
Mostrar másMultiple Myeloma remains an incurable plasma cell malignancy, and patients with relapsed/refractory disease continue to face limited therapeutic options and poor clinical outcomes. Epunamin, in combination with a DECP-based regimen, may provide a novel therapeutic strategy in this setting. However, evidence from real-world clinical practice remains limited.
Methods:
This is a multicenter, single-arm, r...
Mostrar másA Multicenter Real-World Study Evaluating Epunamin in Combination With a DECP-Based Regimen for Relapsed/Refractory Multiple Myeloma
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DECP-Based Regimen
Multiple Myeloma
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Patients Receiving Epunamin Combined With DECP-Based Regimen Patients with relapsed/refractory Multiple Myeloma will receive Epunamin in combination with a DECP-based regimen as follows:
Epunamin 10 mg/kg administered on days 1-5, or days 1-3 and days 15-17 Cisplatin 10 mg/m² on days 1-4 Etoposide 40 mg/m² on days 1-4 Cyclophosphamide 300 mg/m² on days 1-4 Dexamethasone 20-40 mg on days 1-4 Each treatment cycle lasts 28 days. Patients achieving clinical benefit will receive a...Mostrar más | N/A |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Objective response rate (ORR) is defined as the proportion of evaluable patients who achieve complete response (CR) or partial response (PR) after treatment. | Formal efficacy evaluation will be performed at the end of cycle 4. M-protein and related laboratory parameters will be monitored during each treatment cycle, while bone marrow examination and serum free light chain assessment will be performed every 2 cycles to evaluate depth of response. | At the end of cycle 4 (approximately 4 months) Description |
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. -
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.
Shanxi Bethune HospitalShanxi