Clinical Study of Safety and Tolerability of Melphalan Hydrochloride for R/R MM

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is an investigator-initiated clinical study to evaluate the safety and tolerability of melphalan hydrochloride for injection in patients with relapsed or relapsed refractory multiple myeloma. Using the "3 + 3" dose escalation principle, 3-6 subjects per dose were enrolled, depending on the dose limiting toxicity (DLT) observed in the first cycle of chemotherapy for each subject. After completing the 21-day assessment of the first cycle of chemotherapy, if there was no DLT, the study started for the next dose group.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborator: CASI Pharmaceuticals, Inc.
• Treatments: Melphalan

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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;