Safety and Efficacy of Bortezomib inaddtion to Adriamycin and Intermediate-Dose Dexamethasone (iPAD) in Subjects with Relapse/Refractory Multiple Myeloma with Primary Therapies ; A PhaseI/II, Multicentre, Open-Label, Single-Arm Study
Not Applicable
- Conditions
- Relapse/Refractory Multiple Myeloma
- Registration Number
- JPRN-UMIN000001210
- Lead Sponsor
- Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine, Fukuoka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
1.Use of bortezomib in the previous treatment. 2.History of allergic reactions to compounds containing mannitol, bortezomib, or boron 3.Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to study protocol. 4.Active infection requiring treatment 5.Active hepatitis B or C. 6.Under treatment for a cancer other than multiple myeloma 7.Impaired kidney function requiring dialysis, liver function, cardiac function or pulmonary function. 8.Non-secretory myeloma, plasmacytoma, plasma cell leukemia, and POEMS syndrome. 9.Peripheral neuropathy> grade 2 10.Pregnant, lactation or potential
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Complete remission rate
- Secondary Outcome Measures
Name Time Method PR rate PFS Time to response OS