Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed symptomatic multiple myeloma: a phase2 study
Not Applicable
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000007216
- Lead Sponsor
- Japan Study Group for Cell Therapy and Transplantation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
Not provided
Exclusion Criteria
1. Non-secretory MM and plasmacell leukemia. 2. Patients HIV-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. History of hypersensitivity to mannitol or boron. 8. Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary 9. 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 Probability of CR after consolidation therapy.
- Secondary Outcome Measures
Name Time Method 1. Probability of CR + sCR after induction therapy. 2. Probability of CR + sCR after autologous stem cell transplantation. 3. Probability of sCR after consolidation therapy. 4. Probability of CR + sCR after maintenance therapy. 5. 2-years progression free survival (PFS) 6. 2-years overall survival (OS) 7. Time to progression (TTP) 8. Incidence of adverse events. 9. Probability of molecular remission (mCR) after autologous stem cell transplantation, consolidation therapy, and maintenance therapy. 10. Detection of minimal residual disease (MRD) in autologous grafts.