Status:
UNKNOWN
Clinical Study of Safety and Tolerability of Melphalan Hydrochloride for R/R MM
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
CASI Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 myelom...
Detailed Description
The escalation method was as follows: 1 subject in each dose group was evaluated for safety by the investigator, and another 2 subjects were evaluated with the permission of the investigator: if none ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old, male or female;
- Relapsed or refractory multiple myeloma according to IMWG. There is no requirement for the number of previous treatment lines in this study
- 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;
- Life expectancy ≥ 6 months;
- ECOG score ≤ 2;
- ECG QT interval ≤ 470 ms;
- 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%);
- Tbil ≤1.5 ULN，AST and ALT≤3.0 ULN （Gilbert syndrome except);
- eGFR ≥ 45 ml/min or creatinine ≤ 2mg/dl
- Understand the contents of this study and have signed the informed consent form.
Exclusion
- 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) ;
- primary refractory disease (i.e., no at least MR response to any prior therapy);
- combined clinically significant comorbidities (investigator judged);
- the presence of active infection;
- history of other malignant tumors (except multiple myeloma) within 3 years before signing the informed consent;
- Pregnant or lactating women;
- radiotherapy or other anti-myeloma treatment within 14 days before signing the informed consent;
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05438394
Start Date
October 13 2022
End Date
December 31 2023
Last Update
April 14 2023
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044