Multiple Myeloma
Conditions
Interventions
Lenalidomide 25mg/day (days 1-21), Dexamethasone 20mg/day (days 1, 8, 15, 21), Clarithromycin 200mg twice a day (days 1-28) in a 28-day cycle
Lenalidomide 25mg/day (days 1-21), Dexamethasone 20mg/day
Sponsors
Nara Hospital Kinki University School Of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ;Japanese patient with primary refractory or relapsed/refractory multiple myeloma ;Agree in writing to voluntarily participate in the study by have been obtained ;ECOG performance status: 0-2 ;Measurable serum or urine M-protein ;Agree to register and follow RevMate
Exclusion criteria
Exclusion criteria: Cardiac infarction within 6 months Deep vein thrombosis or pulmonary embolism within 3 years Tuberculosis,herpes simplex keratitis, mycosis, or other active infections at baseline Uncontrollable diabetes mellitus, hypertension, peptic ulcer, or glaucoma Posterior capsule opacification Patients with mental illness Those who are considered as inappropriate to register by attending physicians Pregnant or breast feeding females Grade 2 or more peripheral neuropathy Any of following laboratory abnormalities Absolute neutrophil count < 1000 Platelet count< 75000 Creatinine clearance < 60 mL/ min Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for > 3 years Radiotherapy within 14 days Wound by recent organ surgery HIV-positive Known hypersensitivity to dexamethasone Known hypersensitivity to macrolides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose, Best response rate, Duration of response, Progression-free survival | — |
Countries
Japan
Contacts
Public Contacthitoshi hanamoto
Nara Hospital Kinki University School Of Medicine Department of Hematology
Outcome results
None listed