A feasible study of lenalidomide for multiple myeloma in maintenance use at post autologous peripheral blood stem cell transplantatio
Phase 1
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000012100
- Lead Sponsor
- Ochanomizu blood study committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Known hypersensitivity to lenalidomide (2) Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 2 (3) Uncontroled infectious diseases (4) HBs antigen, HCV antibody positive (5) HTLV-I antibody, HCV antibody positive (6) Pregnancy or breastfeeding (7) Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimation of "feasible initial dose level"
- Secondary Outcome Measures
Name Time Method (1) DLT frecquencies (2) Adverse event frequencies (3) A continuous administration period (4) A complete response rate after lenalidomide administration (3 months) (5) Time to progression