Phase II study of lenalidomide consolidation/maintenance therapy after autologous stem cell transplantation in patients with symptomatic multiple myeloma.
Not Applicable
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000004421
- Lead Sponsor
- Japan Study Group for Cell Therapy and Transplantation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
Not provided
Exclusion Criteria
1.Peripheral neuropathy (>=grade 2) 2.Prior high dose dexamethasone therapy caused severe adverse events as follows; Liver dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension, infection. 3.Patient was suspected pneumonia (Interstitial pneumonia) by high dose dexamethasone therapy. (Consult a respiratory specialist if necessary) 4.Those who are considered as inappropriate to register by attending physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Probability of CR+VGPR after lenalidomide plus dexamethasone consolidation therapy.
- Secondary Outcome Measures
Name Time Method 1.Probability of CR+VGPR after lenalidomide maintenance therapy. 2.time to progression (TTP) 3.2-years progression free survival (PFS) 4.2-years overall survival (OS) 5.Incidence of adverse events