A Phase 1/2 study of induction therapy with Thalidomide, Melphalan and Prednisolone for newly diagnosed multiple myeloma patients ineligible for hematopoietic stem cell transplantatio
- Conditions
- ewly diagnosed multiple myeloma ineligible for hematopoietic stem cell transplantation
- Registration Number
- JPRN-jRCT2080222743
- Lead Sponsor
- Fujimoto Pharmaceutical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
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
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 < 2,000 /mm3, Neutrophil < 1,000 /mm3 or Platelet < 50,000 /mm3
7. Serum creatinine > 3.0 x ULN
8. Serum AST or ALT > 3.0 x ULN
9. Patients under uncontrollable conditions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate (CR + PR) based on the EBMT criteria
- Secondary Outcome Measures
Name Time Method 1. Assessment of effectiveness<br>(1)Response rate at each assessment time point<br>(2)Time to response<br>(3)Duration of response<br>2. Assessment of safety <br>(1)Laboratory test<br>(2)Vital signs, body weight and electrocardiographic test<br>(3)Clinical findings<br>(4)Adverse events