Newly diagnosed multiple myeloma ineligible for hematopoietic stem cell transplantation
Conditions
Interventions
investigational material(s)
Generic name etc : Thalidomide, Melphalan, Prednisolone
INN of investigational material : Thalidomide, Melphalan, Prednisolone
Therapeutic category code : 429 Other antitu
Sponsors
Fujimoto Pharmaceutical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria 1. Patients with symptomatic multiple myeloma as of IMWG diagnostic criteria 2. Patients with multiple myeloma received no prior treatment with chemical therapeutics. 3. Patients older than 65, or those between 20 and 64 ineligible for hematopoetic stem cell transplantation 4. Serum M-protein >= 500 mg/dL or urinary M-protein excretion >= 200 mg/24h 5. ECOG Performance Status (PS) 0-2 or 3 with osteolytic lesions 6. Patients who have submitted the informed consent to Thalidomide Education and Risk Management System
Exclusion criteria
Exclusion criteria: 1. Patients who have received any thalidomide preparation 2. Patients who have received other drugs for multiple myeloma treatment 3. Patients in pregnancy or lactation 4. Patients who have the medical history of deep vein thrombosis / pulmonary embolism 5. Patients who are positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody 6. White blood cell 3.0 x ULN 8. Serum AST or ALT > 3.0 x ULN 9. Patients under uncontrollable conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate (CR + PR) based on the EBMT criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of effectiveness (1)Response rate at each assessment time point (2)Time to response (3)Duration of response 2. Assessment of safety (1)Laboratory test (2)Vital signs, body weight and electrocardiographic test (3)Clinical findings (4)Adverse events | — |
Outcome results
None listed