Phase I/II trial of subcutaneous bortezomib plus lenalidomide combined with dexamethasone combination therapy for relapsed or refractory multiple myeloma patients
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000013067
- Lead Sponsor
- Fukuoka Blood and Marrow Transplantation Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1) Peripheral neuropathy and neuropathic pain >=Grade 2(CTCAE ver.4.0). 2) Those who can not receive bortezomib subcutaneously at a dose of 1.3 mg/m2 3) History of hypersensitivity to lenalidomide, bortezomib, dexamethasone, mannitol or boron. 4) Nonsecretory multiple myeloma, solitary plasmacytoma, plasma cell leukemia or POEMS syndrome. 5) Known human immunodeficiency virus (HIV) infection or active hepatitis A, B or C. 6) Serious concurrent uncontrolled medical disorder. (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction diabetes, hypertension and infectious diseases) 7) History of active malignancy during the past 5 years 8) Psychoneurotic disorder, depression state or history 9) Pregnant or lactating female 10) Patients with pneumonia, pulmonary fibrosis or bilateral interstitial abnormalities. 11) 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 1) Phase I To determine the maximum tolerated dose (MTD) of subcutaneous bortezomib administrated once weekly, lenalidomide administrated for 3 weeks when combined with dexamethasone in a 28-day schedule. 2) Phase II To investigate the efficacy of a 8 cycles of subcutaneous bortezomib, lenalidomide and dexamethasone at the recommended dose level determined by the phase I trial.
- Secondary Outcome Measures
Name Time Method