EUCTR2014-002187-32-DK
Active, not recruiting
Phase 1
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 sitesJuly 10, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- multiple myeloma
- Sponsor
- Danish Myeloma Study Group
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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