multiple myeloma (including plasma cell leukemia)
Conditions
Interventions
Lenalidomide maintenance therapy starts between 100 and 365 days after allogeneic stem cell transplantation. Three dose-levels (5 mg/every other day, 5 mg/day, 10 mg/day) will be investigated. Within
Sponsors
Division of Hematology, Saitama Medical Center, Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with symptomatic multiple myeloma (including plasma cell leukemia), and more than 100 days after allogeneic hematopoietic stem cell transplantation (2) Regardless of the period from diagnosis to maintenance therapy, pretreatment, conditioning regimen, and graft source (3) Age at agreement acquisition between 18 and 65 years old (4) ECOG performance status being 0 or 1 (5) Patients who have the following laboratory values 14 days before enrollment 1. SpO2 >= 94% 2. Creatinine clearance >= 30 ml/min 3. Total bilirubin <= 2 mg/dl 4. AST and ALT <= 3 x upper limit of normal 5. Normal electrocardiogram 6. Ejection fraction >= 45% (6) The agreement in the document obtained from the person himself about participation in this study (Parental consent is required if patients are < 20 yaers old.)
Exclusion criteria
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/uL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShun-ichi Kimura
Saitama Medical Center, Jichi Medical University Division of Hematology
Outcome results
None listed