Targeting Complete Response in Younger transplant-eligible Multiple myeloma patients with Bortezomib and Lenalidomide treatment after relapse with autologous stem cell transplantatio
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000013704
- Lead Sponsor
- Division of Hematology, Saitama Medical Center, Jichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 41
Not provided
1) Patients with a past history of allergy to the drug described in the protocol 2) Patients daiagnosed plasma cell neoplasm other than symptomatic multiple myeloma 3) Patients who cannnot be expected to live for more than 3 months 4) Patients who have had a complication of active double cancer* within the past 5 years *Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment, or lesions corresponding to intramucosal carcinoma (cervical carcinoma presenting in FIGO stage I) 5) HBs antigen, HCV antibody or HIV antibody positive patients 6) Patients with grade 2 or severer peripheral neuropathy or peripherl neurogenic pain (CTCAE v4.0) 7) Patients who have or suspected of having a serious active infection 8) Patients with serious mental disorders 9) Patients with serious pulmonary dysfunction 10) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality (e.g. a shadow of ground-glass opacity) on CT scan regardless of the presence or absence of symptoms (these patients should be enrolled after consultation with a respiratory specialist or radiologist) 11) Patients who have serious cardiac dysfunction or present with ECG or a chest diagnostic image that indicates treatment 12) Patients who are complicated by poorly controlled diabetes mellitus 13) Patients who are receiving hemodialysis 14) Patients who have serious liver dysfunction 15)Women who are or may be pregnant or are nursing 16) Other patients who are, in the opinion of the caring investigator, unfit for enrolloment in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of achivement of CR or more after VRD therapy
- Secondary Outcome Measures
Name Time Method 1) Distribution of all response after treatment 2) The ratio of patients who complete the treatment protocol 3) 2 year progression free survival 4) 2 year overall suvival 5) safety