Newly diagnosed multiple myeloma
Conditions
Interventions
Low-dose oral melphalan:Oral administration of MEL 200mg/m2
Injection melphalan of the expansion cohort:Intravenous administration of MEL 200 mg/m2
Median-dose oral melphalan:Oral administration of MEL 220mg/m2
High-dose oral melphalan:Oral administration of MEL 240mg/m2
Oral melphalan of the expansion cohort:The maximum oral MEL dose of tolerance
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 18 to 75 years old, regardless of gender; 1.Newly diagnosed myeloma patients undergoing ASCT; 2.Presence of measurable lesions including any of the following criteria: serum protein electrophoresis showing M protein (SPEP) >= 10g/L or 24-hour urine light chain >= 200mg or affected blood free light chain >= 100mg/L. Non secretory type uses the number of bone marrow plasma cells as an evaluation index, requiring a bone marrow plasma cell percentage of >= 30%; 3.Normal liver and kidney function; 4.Participants must personally sign an ethics committee approved informed consent before screening phase.
Exclusion criteria
Exclusion criteria: 1.Newly diagnosed with plasma cell leukemia, amyloidosis, and POEMS disease; 2.Active hepatitis B (HBV-DNA >= 1 × 10^3 copies/ml); 3.HIV infected individuals; 4.Active infections requiring intravenous antibiotic treatment; 5.Serious damage to important organ functions: respiratory failure, heart failure, decompensated liver dysfunction, renal dysfunction, etc; 6.Patients who use drugs or engage in long-term alcohol abuse, which affects the evaluation of research results; 7.Individuals with mental disorders/unable to obtain informed consent; 8.Patients who are allergic to research drugs; 9.The researcher has determined that they are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactJie Xu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed