Targeting complete response by Upfront Bortezomib followed by Autologous transplantation and consolidataion therapy
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000002442
- Lead Sponsor
- Division of Hematology, Saitama Medical Center, Jichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 47
Not provided
Exclusion criteria 1. Patients with a past history of allergy to the drug described in the protocol 2. Patients diagnosed with smoldering myeloma or MGUS 3. Patients who cannot 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 (excluding 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 peripheral neurogenic pain (Ctcae v3.0 JCOG/JSCO ver.) 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 (high-resolution CT) regardless of the presence or absence of symptoms (these patients should be enrolled after consultation with a respiratory specialist or a 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 on account of nephropathy other than the underlying disease 14. Women who are or may be pregnant or are nursing 15. Other patients who are, in the opinion of the caring investigator, unfit for enrollment in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of achivement of CR or more (sCR, CR) 100 days after autologous stem cell transplantation
- Secondary Outcome Measures
Name Time Method Distribution of all response after treatment, The ratio of patients who complete the treatment protocol 3 year progression free survival 3 year overall survival safety