Unfit patients with relapsed or refractory multiple myeloma
Conditions
Interventions
Lenalidomide 10mg daily on day 1-21 every 28 days, Dexamethasone 20mg a week on day 1, 8, 15, and 22 every 28 days Lenalidomide dose will be escalated from 10mg to 25mg (5mg per cycle) if there are n
Sponsors
Gifu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Multiple myeloma diagnosed in the criteria of IMWG (2) Patients aged 20 years old and over with autologous stem cell transplantation ineligible multiple myeloma (3) There is no treatment experience with lenalidomide, relapsed or refractory multiple myeloma patients with medical history over the past 1 regimen (bortezomib intolerance, also including patients paraprotein relapse) (4) Patients who have been judged by the initial dose of the attending physician is necessary loss of lenalidomide (5) Patients with ECOG of Perfomance Status (PS) 0-3 (6) Patients who keep the function of major organs, it meets the following criteria 1. Neutrophil count 1,000 / mm3 or more 2. Platelets 50,000 / mm3 or more 3. Serum total bilirubin value is less than three times of the facility upper limit of normal 4. Serum AST, ALT value is less than five times of the facility upper limit of normal (7) 6 months or more of survival can be expected (8) Creatinine clearance 30 mL / min or more (9) Patients who can comply with lenalidomide drug management procedures (RevMate) (10) In patients receiving notice, that consent in writing was obtained from his participation in the study
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The best response during 1 year from initiation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| (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) | — |
Countries
Japan
Contacts
Public ContactJunichi Kitagawa
Gifu University Hospital Department of hematology
Outcome results
None listed