Evaluation of the Feasible dose of Lenalidomide as maintenance therapy after Allogeneic hematopoietic stem cell Transplantation for multiple myeloma
Phase 1
- Conditions
- multiple myeloma (including plasma cell leukemia)
- Registration Number
- JPRN-UMIN000010470
- Lead Sponsor
- Division of Hematology, Saitama Medical Center, Jichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with poorly controlled in spite of the continuous use of insulin (2) Patients with poorly controlled hypertension (3) Patients with poorly controlled active infection (4) Patients with coexistence of malignancy (5) Patients who are or may be pregnant or are nursing (6) Patients with serious mental disorder (7) Patients with HBs antigen or HBe antigen positive (8) Patients with HIV antibody positive (9) Patients who are allergic to lenalidomide or thalidomide (10) Patients with active acute or chronic GVHD (11) Patients with platelet count < 30,000/uL or neutrophil count < 1,000/u
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: dose limiting toxicity and maximum tolerated dose Phase II: the rate of improvement of remission status after 4 cycles lenalidomide maintenance therapy
- Secondary Outcome Measures
Name Time Method 1) adverse event frequencies 2) acute and chronic GVHD 3) a continuous administration period 4) 1-year overall survival after transplantation 5) 1-year progression-free survival after transplantation 6) T,NK-cells recovery and activation status