Efficacy and safety of dose-escalating lenalidomide and dexamethasone (Rd) for unfit patients with relapsed or refractory multiple myeloma
- Conditions
- nfit patients with relapsed or refractory multiple myeloma
- Registration Number
- JPRN-UMIN000019917
- Lead Sponsor
- Gifu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Patients who have received treatment with lenalidomide (2) Patients who have hypersensitivity to lenalidomide or dexamethasone (3) non-secretory myeloma, solitary plasmacytoma, plasma cell leukemia, of POEMS syndrome patients (4) HBs antigen positive, HCV antibody-positive, HTLV-I antibody-positive cases, of HIV antibody-positive patients (5) Patients with a history of malignancy (6) Patients with pregnancy, patients who may be pregnant, or patients during lactation (7) uncontrolled liver dysfunction, renal dysfunction, cardiac dysfunction, lung dysfunction, diabetes, A high blood pressure, infections (8) patients with severe mental disorders (9) patients with deep vein thrombosis or pulmonary embolism (10) Patients who are regarded as inappropriate for participation to this clinical study by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The best response during 1 year from initiation of treatment.
- Secondary Outcome Measures
Name Time Method (1) Safety: Hematological toxicity of grade 4, non-hematological toxicity of grade 3 to 4 (2) Continuation rate of treatment (3) Total dosage of lenalidomide (4) Overall survival (5) Progression-free survival (the rate of patients who are not recognized as having progression or recurrence)