A phase II study of subcutaneous injection of bortezomib in combination with oral cyclophosphamide and dexamethasone (sVCD) for relapsed or refractory multiple myeloma
Phase 2
Recruiting
- Conditions
- relapsed or refractory multiple myeloma
- Registration Number
- JPRN-UMIN000006490
- Lead Sponsor
- Kyushu Hematology Organization for Treatment (KHOT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
Not provided
Exclusion Criteria
1.History of allergic reactions to compounds containing mannitol, bortezomib, or boron. 2.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. 3.Active infection requiring treatment 4.Active hepatitis B or C. 5.Under treatment for a cancer other than multiple myeloma 6.Impaired kidney function requiring dialysis, liver function, cardiac function or pulmonary function. 7.Non-secretory myeloma, plasmacytoma, plasma cell leukemia, and POEMS syndrome. 8.Peripheral neuropathy > grade 2 9.Pregnant, lactation or potential
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to assess the efficacy of sVCD therapy for up to 6 cycles in patients with multiple myeloma who are relapsed or refractory to prior treatment.
- Secondary Outcome Measures
Name Time Method The soconday objective is to assess the safety of subcutaneous injection of bortezomib and sVCD therapy.