A randomized placebo-controlled phase II study of clarithromycin or placebo combined with VCD induction therapy prior to high-dose melphalan with stem cell support in patients with newly diagnosed multiple myeloma

Danish Myeloma Study Group0 个研究点开始时间: 2014年7月10日最近更新: 2016年10月10日

适应症

试验速览

暂无简介。

•Myeloma diagnosis according to IMWG criteria
•Treatment demanding disease
•High-dose melphalan with stem cell support scheduled as a part of the treat-ment
•Signed informed consent given prior to any study related activities
•Age > 18 years
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•Allogeneic transplantation scheduled as a part of the treatment
•Myeloma treatment prior to entry in the study, except radiotherapy, bisphos-phonates/denusumab or corticosteroids for symptom control
•Concurrent disease making clarithromycin treatment unsuitable
•Positive pregnancy test (only applicable for women with childbearing poten-tial)
•Known or suspected hypersensitivity or intolerance to claritromycin
•Prolonged QT corrected (QTc) interval ( > 500 msec on screening ECG)
•Concurrent treatment with cabergoline, fluconazole, ketoconazole, pimozide, quetiapine, sirolimus, verapamil, tacrolimus, ergot alkaloid, simvastatin or other statins
•Uncontrolled or severe cardiovascular disease including myocardial infarc-tion within 6 months of enrolment, uncontrolled angina or known cardiac amyloidosis
•Severe renal dysfunction (estimated creatinine clearance <10 mL/min)
•Serious medical or psychiatric illness which, in the judgment of the investi-gator, would make the patient inappropriate for entry into the study

发起方

Danish Myeloma Study Group