Efficacy and safety of VRd (bortezomib, lenalidomide, dexamethasone) induction therapy, autologous hematopoietic stem cell transplantation, KRd (carfilzomib, lenalidomide, dexamethasone) consolidation and lenalidomide maintenance therapy for newly-diagnosed multiple myeloma (phase II study).
Not Applicable
- Conditions
- ewly-diagnosed multiple myeloma
- Registration Number
- JPRN-UMIN000036375
- Lead Sponsor
- Tokyo-Kita Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who are allergic to drugs used by this protocol study 2) Patients with severe cardiac dysfunction 3) Patients with active and uncontrolled infections 4) Patients with HBs antigen (+) or HCV antibody (+). 5) Patients with uncontrolled malignancies 6) Pregnant women, women who could be pregnant or women who is breast feeding 7) Patients with uncontrolled gastric ulcer 8) Past history of renal transplantation 9) Past history of pulmonary embolism, cardiac infarction and/or brain infarction 10) Patients with uncontrolled diabetes 11) severe psychiatric disorders 12) Patients with other inadequate conditions determined by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate after KRd consolidation therapy
- Secondary Outcome Measures
Name Time Method 1.Overall survival rate 2.Progression-free survival rate 3.Response rates after each regimes 4.Best response rate 5.Number of CD34 positive cell yield by PBSCH 6.Adverse events of each regimens