enalidomide/dexamethasone Salvage Therapy with stepwise Evatuation for Practical Dose Finding Study
- Conditions
- refractory/resistant multiple myeloma
- Registration Number
- JPRN-UMIN000011568
- Lead Sponsor
- Saitama Medical Center,Saitama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall response after 6 cycles
- Secondary Outcome Measures
Name Time Method 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