Bortezomib consolidation in patients with myeloma following treatment with high-dose melphalan and autologous stem cell support. A randomised NMSG trial (15/05)

ordic Myeloma Study Group0 个研究点目标入组 400 人开始时间: 2007年10月31日最近更新: 2012年3月19日

试验速览

暂无简介。

•·Symptomatic myeloma diagnosis according to criteria in study protocol attachment 3
•·ASCT is performed or has been performed in the last five weeks (time limit two weeks for patients randomised at 2nd transplantation) as a part of primary therapy
•·Signed informed consent given prior to any study related activities have been performed
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•·Prior exposure to bortezomib
•·Allogeneic transplantation scheduled as a part of the primary treatment
•·Neuropathy > Grade 2 (neurological symptoms interfering with ADL)
•·Non-secreting myeloma
•·Other concurrent disease making bortezomib treatment unsuitable
•·Positive pregnancy test (only applicable for women with childbearing potential)
•·Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
•·Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
•·History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] <100 mmHg and/or sitting diastolic blood pressure [DBP] <60 mmHg)
•·Serious medical or psychiatric illness likely to interfere with participation in this clinical study
•·Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study

发起方

ordic Myeloma Study Group