Efficacy and safety of intensified induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma: a phase2 study
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000016440
- Lead Sponsor
- Clinical Research Support Center Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 53
Not provided
1. Non-secretory MM, plasma cell leukemia, POEMS syndrome, and Waldenstrom Macroglobulinemia. 2. Patients with amyloidosis. 3. Patients who have been undergoing surgery or radiation treatment within 14 days before participating the study. 4. Patients who received prednisolone more than 30mg/day within 14 days before participation. 5. Involvement of central nervus system with myeloma cells 6. Patients HIV-positive, HBs antigen positive, and HCV antibody positive (except HCV-PCR negative). 7. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 8. Patients with a history of active malignancy during the past 5 years. 9. Patients with psychiatric disorders such as schizophrenia etc. 10. Pregnant women, pre-menopausal women, and lactating women. 11. History of hypersensitivity to mannitol or boron. 12. Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary 13. 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
- Secondary Outcome Measures
Name Time Method