Phase II trial of bortezomib, lenalidomide, and dexamethasone in patiens with high-risk smoldering myeloma
- Conditions
- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0006266
- Lead Sponsor
- Chonnam National University Hospital Hwasun Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 21
1.Age 19~75
2.High-risk smoldering multiple myeloma (2~3 of the followings)
- serum M-protein = 2 g/dL
- Serum free light chain ratio (involved/uninvolved) = 20
- Bone marrow plasma cells = 20%
3.Adequate organ function
- Absolute neutrophil count = 1.0 x 109/L
- Platele = 50 x 109/L
(= 30 x 109/L if myeloma involvement is > 50% in the bone marrow)
- Hemoglobin = 8.0 g/dL (?? ??)
- Creatinine clearance = 30 mL/minute
- Bilirubin ???? = 1.5 x upper normal limit
- AST and ALT = 3 x upper normal limit
4.Eastern Cooperative Oncology Group performance scale 0, 1 or 2
5.Expected survival > 3 months
6.Well-controlled HBV or HCV infection
7.Written informed consents
Active multiple myeloma
2.Low-intermediate risk SMM
3.Monoclonal gammopathy of undetermined significance
4.Prior treatment for SMM
5.Pregnant or lactating women
6.Myocardial infarct within 6 months, heart failure of NYHA Class III~IV, uncontrolled ventricular arrhythmia, history of severe coronary arterial disease
7.Uncontrolled hypertension or diabetes
8.Neuropathy grade 3~4
9.HIV infection
10.Patients with severe or uncontrolled medical conditions, abnormal laboratory findings, or psychiatric disorders
11.Hypersensitivity to the investigational products
12.Synchronous or metachronous malignant tumor other than SMM within 5 years
(except for adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, adequately resected differentiated thyroid cancer, intraepithelial carcinoma of the neck or breast, or prostate cancer that can be monitored for progress status without any treatment).
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progression free survival rate
- Secondary Outcome Measures
Name Time Method Overall response rate, complete response rate, progression free survival1 (time to MM development), progression free survival2 (progression free survival after starting definite treatment for active myeloma), overall survival, minimal residual disease negative convertion rate