refractory/resistant multiple myeloma
Conditions
Interventions
The administration of lenalidomide (15 mg/day, days 1-21, po), and dexamethasone (20 mg/day day 1, 8, 15, 22, po) in each cycle.(28 days). If the patients achieve PR and more state, total 6 cycles wi
Sponsors
Saitama Medical Center,Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group(IMWG) (2) patients with aged more than 15 years old who diagnosed ineligible for autologous stem cell transplantation at induction therapy (3) refractory/resistant multiple myeloma patients who were untreated with lenalidomide, and has a history of more than one regimen (4) performance status:0-3 *neutrophil count; more than 1,000/mm3 *platelet count; more than 50,000/mm3 *total billbin in serum; 3 times less than normal upper limit *AST, ALT in serum; 5 times less than normal upper limit (6) be expected to be alive more than 6 months (7) creatinin clearance>=60ml/min (8) without a history of deep vein thrombosis and pulmonary thrombosis (9) patients who are observed RevMate (10) Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.
Exclusion criteria
Exclusion criteria: (1)Patients with a past history of receiving lenalidomide (2)Patients with a past history of allergy to lenalidomide and thalidomide (3) Patients with non-secretary myeloma, solitary myeloma, plasma cell leukemia, or POEMS syndrome (4) HBs antigen,or HCV antibody positive patients (5) HTLV-1 antibody,or HCV antibody positive patients (6) Patients with a history of malignancies (7) Womeb with pregnancy or during lactation (6) be expected to be alive more than 6 months (7) creatinine clearance>=60ml/min (8) without a history of deep vein thrombosis and pulmonary thrombosis (9) patients who are observed RevMate (10) Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information. (8) Patients with uncontrolled dysfunction of liver, kidney, heart, diabetes, hypertension, and infection (9) Patients with serious abalienation (10) Patients with deep vein thrombosis or pulmonary thrombosis (11) Other patients who are in the opinion of the caring investigator, unfit for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response after 6 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. lenalidomide concentration in serum 2. the incidence of DLT 3. the incidence of adverse events 4. the persistent ratio after 6 cycles 5. TTP | — |
Countries
Japan
Contacts
Public ContactReiko Watanabe
Saitama Medical Center,Saitama Medical University Department of Hematology
Outcome results
None listed