Randomized phase II study of two induction treatments of melphalan, prednisolone, plus bortezomib, JCOG-MPB versus modified PETHEMA-MPB, in elderly patients or non-elderly patients refusing transplant with untreated symptomatic myeloma(JCOG1105, IMPROVE-MPB study)
Phase 2
- Conditions
- Elderly patients or non-elderly patients refusing transplant with untreated symptomatic myeloma
- Registration Number
- JPRN-UMIN000011180
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous malignancy 2) Active infection 3) Pregnant or nursing women 4) Psychiatric disease 5) Continuous systemic treatment with steroids for non-malignant disorders 6) Insulin-dependent or uncontrollable diabetes mellitus 7) Uncontrollable hypertension 8) HBs-Ag positive or HCV-Ab positive 9) HIV-Ab positive 10) Interstitial pneoumonia, pulmonary fibrosis, severe pulmonary emphysema, or severe pleural effusion on chest CT 11) Uncontrollable Glaucoma 12) Allergic history to borate or mannitol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate
- Secondary Outcome Measures
Name Time Method proportion of treatment completion, overall response rate, stringent complete response rate, overall survival, progression-free survival, time to next treatment, adverse events, serious adverse events, efficacy according to chromosomal translocation-associated protooncogene expression