Clinical trial to evaluate efficacy and safety of cyclophosphamide, bortezomib and dexamethasone (CBD) induction and autologous stem cell transplantation for patients for newly diagnosed multiple myeloma (NBMT-ASCT1201)
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000008399
- Lead Sponsor
- Toyohashi Municipal Hospital Division of Hematology and Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 54
Not provided
1. multiple myeloma defined by IMWG criteria 2. symptomatic multiple myeloma defined by IMWG 3. no previous anti-myeloma chemotherapy 4. aged >20 and <65 5. PS(ECOG) 0-2 6. existence of measurable disease (one of the following) 1) serum M protein > 1g/dL 2) 24-hr urine M protein > 200 mg 7. voluntary written informed consent 1. plasma cell leukemia 2. severe renal damage: serum Cr > grade 3 even after correction of dehydration and hypercalcemia 3. severe cardiac dysfunction 1) LEVF < 50% 2) angina pectoris or acute myocardial infarction within 6 months of enrollment 3) congestive heart failure requiring medical treatment 4) arrhythmia requiring medical treatment. 4. severe respiratory dysfunction 1) SpO2 < 92% 2) interstitial pneumonitis 3) Chronic Obstructive Pulmonary Disease 4) active pneumonia 5. sever liver dysfunction 1) AST,ALT elevation > grade 2 (5xULN) 2) Total bilirubin elevation > grade 2 (3xULN) 6. infection 1) HIV positive 2) HBs antigen positive 7. peripheral neuropathy > grade 2 8. poor controlled diabetes mellitus even after treatment, having one or more of the following 1) HbA1c >8.0%, 2)fasten blood sugar > 160 mg/dL, 3) blood sugar after 2h of eating > 220 mg/dL 9. others 1) active opportunistic infection 2) active double cancer 3) doctor judged adequate to enroll the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year progression free survival
- Secondary Outcome Measures
Name Time Method 1.incidence of adverse events 2.incidence of therapy related mortality 3. pretreatment risk factors for prognosis 1) ISS 3, 2) serum LDH level, 3) cytogenetic abnormality, 4) t(4;14), t(14;16) or deletion of 17q proved by FISH analysis 4. treatment response 1) after CBD induction, 2) 12 weeks after ASCT 3)after consolidation, 4) after maintenance, and 5)at best response 5.time to progression 6. relapse free survival 7. overall survival 8. incidence of secondary primary malignancy 9.impact of response on prognosis 1) pre high-dose therapy, 2) post high dose therapy, 3) post consolidation