multiple myeloma
Conditions
Interventions
lemalidomide treatment
Sponsors
Kurume University Hospital Division of Hematology and Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) relapse and refractory multiple myeloma without previously treated lenalidomide 2) assessable M proteinemia or M proteinuira 3) preserved mail organ function and implement the following criteria 4) promising more than 3 months living 5) menopausal female and male and female are enable to prevent conception by the adequate methods, including the surgical conception 6) complete informed concent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and quality of life | — |
Countries
Japan
Contacts
Public ContactKoichi Osaki
Kurume University Hospital Hematology and Oncology
Outcome results
None listed