Clarithromycin in Multiple Myeloma Induction Therapy

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrik Gregersen
• Collaborator: Danish Myeloma Study Group
• Treatments: Clarithromycin

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 treatment

• Signed informed consent given prior to any study related activities

• Age > 18 years

Exclusion Criteria:

• Allogeneic transplantation scheduled as a part of the treatment

• Myeloma treatment prior to entry in the study, except radiotherapy, bisphosphonates/denosumab or corticosteroids for symptom control

• Concurrent disease making clarithromycin treatment unsuitable

• Positive pregnancy test (only applicable for women with childbearing potential)

• Known or suspected hypersensitivity or intolerance to clarithromycin

• 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 infarction 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 investigator, would make the patient inappropriate for entry into the study