Multiple myeloma
Conditions
Interventions
Low-dose lenalidomide plus dexamethasone (rd) therapy consists of lenalidomide 10 mg/day (day 1-21) and dexamethasone 20 mg/week (day 1, 8, 15, 22). Each cycle is repeated every 4 weeks. This treatmen
Sponsors
Department of Hematology and Rheumatology, Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has given voluntary written informed consent 2. Patient was diagnosed with symptomatic multiple myeloma based on IMWG criteria or multiple myeloma on SWOG criteria 3. Quantifiable serum or urine monoclonal protein value 4. Patient is 65 years old or older at study entry or younger patients between 20 and 64 years old who are not candidate to autologous stem cell trasnplantation 5. Patient has a performance status (ECOG) of 0 to 2 6. Patient was treated with melphalan/prednisone as initial therapy. Not meeting criteria for PD. Any of the following: * < 10% reduction of serum or urine monoclonal protein during MP therapy * Less than PR after 3 cycles of MP * Less than VGPR after 6 cycles of MP * After 9 cycles of MP in patients with a VGPR/CR/sCR after 6 cycles of MP * Interruption of MP therapy due to toxicity
Exclusion criteria
Exclusion criteria: 1. Acute myocardial infarction within 6 months or deep venous thrombosis/pulmonary thrombosis within 3 years before study entry 2. Active tuberculous disease 3. Poorly controlled insulin-dependent diabetes mellitus 4. Serious psychiatric illness 5. Pregnant or lactating females 6. Any of the following laboratory abnormalities: * Absolute neutrophil count <= 1.0 x 10~9/L * Platelet count <= 50 x 10~9/L * Aspartate transaminase (AST) > 5.0 x the upper limit of normal (ULN) * Alanine transaminase (ALT) > 5.0 x the ULN * Serum creatinine >= 3 mg/dl 7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years 8. Positive for HIV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| TTP ORR CR OS safety | — |
Countries
Japan
Contacts
Public ContactYasushi Onishi
Tohoku University Hospital Department of Hematology and Rheumatology
Outcome results
None listed