Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VD (Velcade, Dexamethasone) Induction Followed by HDT With ASCT and thalidomide maintenance for Newly Diagnosed MM
- Conditions
- ewly Diagnosed Multiple Myeloma
- Registration Number
- JPRN-UMIN000002611
- Lead Sponsor
- Ochanomizu blood study committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Not provided
1. History of allergic reaction attributable to compounds containing boron or mannitol 2. Known hypersensitivity to thalidomide or dexamethasone 3. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 4. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 5. Acute severe infection requiring antibiotic therapy 6. Previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin) 7. Pregnancy or breastfeeding 8. Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion) 9. Previous renal transplantation 10. Recurrent deep vein thrombosis or pulmonary embolism 11. Uncontrolled diabetes mellitus 12. Receipt of extensive radiation therapy within 4 weeks ((Extensive means RT to more than 2 anatomic sites).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the response rate of patients given sequential VAD and VD induction followed by high dose therapy with autologous stem cell transplantation 2.To assess the toxicities of sequential VAD and VD induction chemotherapy, high dose therapy with autologous stem cell transplantation
- Secondary Outcome Measures
Name Time Method