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

Phase 1

Active, not recruiting

• Conditions: multiple myeloma; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-002187-32-DK
• Lead Sponsor: Danish Myeloma Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-10
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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
F.1.3.1 Number of subjects for this age range 80

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified