Open-labeled, multicenter phase II study of bortezomib maintenence theraphy in transplant-ineligible multiple myeloma patients who have major response to induction chemotheraphy

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 78 人开始时间: 待定最近更新: 2020年4月21日

试验速览

暂无简介。

•1)Patients who have diagnosed with multiple myeloma based on diagnostic criteria according to International myeloma working group (IMWG) and are able to judge participation voluntarily in clinical trial
•2)Patients having grade 1 or lesser peripheral neuropathy
•3)Patients who complete initial therapy for 6-12 months, that treatment have been maintained during the period including best response (best response is defined as sustained status of response for at least two cycles after reaching the minimal M peak level)
•4)Patients who achieved major response including complete response, very good partial response and partial response after first induction chemotherapy
•5)ECOG performance criteria: 0, 1, 2
•6)Adequate hematologic function with absolute neutrophil count = 1,000/mm3, platelet count =75,000/mm3
•7)Adequate hepatic function with serum aspartate aminotransferase, alanine aminotransferase < 3 times the upper limit of normal, serum total bilirubin < 2 times the upper limit of normal,
•8)A negative serum or urine pregnancy test prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause
•9)Informed consent

•1)Patients who presented relapse or refractory to induction treatment
•2)Patients who plan to perform autologous stem cell transplantation
•3)Patients who received an extensive radiation therapy within 4 weeks
•4)Pregnant or lactating women
•5)Seriously abnormal hepatic function with serum aspartate aminotransferase, alanine aminotransferase = 3 times the upper limit of normal; or serum total bilirubin = 2 times the upper limit of normal,
•6)Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
•7)Patients who received major surgery within 14 days
•8)Multiple myeloma which involved central nervous system
•9)Active uncontrolled infection or infection need to administrate intravenously antibiotics within 14 days
•10) Patients who had diagnosed with Waldenstrom’s macroglobulinemia, POEMS syndrome, plasma cell leukemia, Al amyloidosis, myelodysplastic syndrome, or myeloproliferative neoplasm
•11) Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
•12)Ongoing or active infection, known to be Human Immunodeficiency Virus (HIV) positive, clinically active hepatitis B or C
•13) Have history of sensitive Bortezomib, Boron, mannitol
•14)Acute respiratory distress syndrome or pericardial disease

发起方

The Catholic University of Korea, Seoul St. Mary's Hospital