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) - CBD induction and ASCT for patients with newly diagnosed MM patients (NBMT-ASCT1201)

Toyohashi Municipal Hospital Division of Hematology and Oncology0 sites54 target enrollmentJuly 23, 2012

Overview

No summary available.

Registry

who.int

Start Date

July 23, 2012

End Date

December 23, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Toyohashi Municipal Hospital Division of Hematology and Oncology

•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