Safety and efficacy of lenalidomide, dexamethasone, and clarithromycin therapy in Japanese patients with multiple myeloma, a phase I/II study
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-UMIN000007918
- Lead Sponsor
- ara Hospital Kinki University School Of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method