Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.
Phase 2
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000009750
- Lead Sponsor
- Shimousa blood study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1. Non-secretory MM and plasmacell leukemia. 2. Patients with HIV antibody positive, HBs antigen posiive or HCV antibody positive 3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 4. Patients with a history of active malignancy during the past 5 years. 5. Patients with psychiatric disorders such as schizophrenia etc. 6. Pregnant women, pre-menopausal women, and lactating women. 7. Patient was suspected pneumonia (Interstitial pneumonia). 8. Those who are considered as inappropriate to register by attending physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CR/VGPR rate after 4 cycles of VCD therapy
- Secondary Outcome Measures
Name Time Method 1) Incidence of adverse events after 4 cycles of VCD therapy 2) Efficacy of peripheral blood stem cell harvest 3) Time to progression 4) Overall survival at two years after treatment 5) Treatment efficacy at two years after treatment 6) Incidence of adverse event at two years after treatment 7) Relationship between treatment efficacy at 4 cycles of VCD treatment and progression free survival (PFS)