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Clinical Study of Safety and Tolerability of Melphalan Hydrochloride for Injection in the Treatment of Relapsed or Relapsed and Refractory Multiple Myeloma

Fecha inicio: 26/6/2022
Fecha reclutamiento:
Fecha final:
  Enfermedad: Oncology: Multiple Myeloma

To evaluate the safety and tolerability of melphalan hydrochloride for injection in patients with relapsed or relapsed refractory multiple myeloma

País: China
Estado: En proceso
Fase: I
Promotor: CASI Pharmaceuticals {EntreMed} (Other Hospital/Academic/Medical Center)
Población de pacientes: Patients with relapsed or relapsed refractory multiple myeloma.
Área terapéutica: Oncology

Criterios de inclusión:
1. Age = 18 years old, male or female; 2. Relapsed or refractory multiple myeloma according to IMWG. There is no requirement for the number of previous treatment lines in this study 3. With any one of the following measurable indicators: serum protein electrophoresis (SPEP) = 1 g/dL (10 g/L), if IgA, IgD, IgE or IgM multiple myeloma subjects, = 0.5 g/dL (= 5 g/L); urine M protein = 200 mg/24h; serum free light chain (FLC) = 10 mg/dL and abnormal serum free light chain kappa/lambda ratio; 4. Life expectancy = 6 months; 5. ECOG score = 2; 6. ECG QT interval = 470 ms; 7. Neutrophil = 1.0*10^9/L, platelet = 75*10^9/L (or 50 *10^9/L if plasma cell infiltration in bone marrow more than 50%); 8. Tbil =1.5 ULN,AST and ALT=3.0 ULN (Gilbert syndrome except); 9. eGFR = 45 ml/min or creatinine = 2mg/dl 10. Understand the contents of this study and have signed the informed consent form.

Criterios de exclusión:
1. primary amyloidosis, MGUS, or smoldering multiple myeloma or plasma cell leukemia (according to the World Health Organization criteria: peripheral blood = 5%) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin) ; 2. primary refractory disease (i.e., no at least MR response to any prior therapy); 3. combined clinically significant comorbidities (investigator judged); 4. the presence of active infection; 5. history of other malignant tumors (except multiple myeloma) within 3 years before signing the informed consent; 6. Pregnant or lactating women; 7. radiotherapy or other anti-myeloma treatment within 14 days before signing the informed consent;

Género: Both
Edad: Adults; Older Adults
Medicación: Anticancer, alkylating
Duración del tratamiento: No disponible

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