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 个研究点目标入组 54 人开始时间: 2012年7月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

发起方

Toyohashi Municipal Hospital Division of Hematology and Oncology