A clinical phase I study to define recommended dose of cyclophosphamide in combination with bortezomib and dexamethasone(C-BD) for relapsed and refractory multiple myeloma
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000001347
- Lead Sponsor
- Center for Supporting Hematology-Oncology Trial(C-SHOT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
Exclusion criteria includes; 1.Cardiovascular diseases 1) Angina pectoris, and acute myocardial infarction within recent 6 months 2) congestive heart failure which requires treatment 3) arrhythmia which requires treatment 2. Respiratory diseases 1) interstitial pneumonitis 2)COPD 3)infections more than twice which in a previous year 3. infectious diseases 1) HIV infection 2) HBsAg positive 3) HBsAb and/or HBcAb posive 4) anti HCV positive 4. neuropathy 1) peripheral neuropathy grade>= 2 2) neural pain due to peripheral neuropaty 5. diabetes mellitus 6. allergy to cyclophosphamide 7.active double cancer 8.subjects who are not likely to participate in the study for any reason in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method definition of recommended dose for cyclophosphamide in C-BD regimen
- Secondary Outcome Measures
Name Time Method