Investigation of the maximum optimal dosage and efficacy of lenalidomide for the treatment of relapsed and refractory multiple myeloma.
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000010178
- Lead Sponsor
- Kurume University Hospital Division of Hematology and Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
Not provided
1) previously administered lenalidomide 2) hypersensitive reaction for lenalidomide, thalidomide and dexamethazone 3) non-secretory myeloma, solitary plasmacytoma, plasmacell leukemia and POEMS syndrome 4) CTCAE more than grade 3 neutropenia, thrombocytopenia 5) HBsAg is positive 6) HCV is positive, HIV is positive 7) uncontrollable liver dysfunction, renal insufficiency, cardiac dysfunction, respiratory dysfunction, diabetus mellitus, hypertension and infection 8) double cancer 9) psychoneurotic disorder, depression state or history 10) a case for difficult to collect QoL score 11) pregnant female, possible pregnancy or durling lactation 12) pulomonary fibrosis and interstitial pneumonitis interstitial shadow on chest CT, even if no sympton 13) physicians' decision
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method safety and quality of life