Clarithromycin, Sulfamethoxazole/Trimethoprim or Observation in Newly Diagnosed Multiple Myeloma

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect of prophylactic antibiotics in multiple myeloma. One third of patients will received treatment with clarithromycin, one third of patients will receive treatment with sulfamethoxazole/trimethoprim and one third will be observed without prophylactic antibiotics. All patients receive concurrent anti-myeloma treatment.

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

Details

• Lead Sponsor: Henrik Gregersen
• Collaborator: Danish Myeloma Study Group
• Treatments: Clarithromycin; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• Myeloma diagnosis according to IMWG criteria

• Treatment demanding disease

• Signed informed consent given prior to any study related activities, except bone marrow samples for diagnosis, FISH, biobanking, and skeletal x-ray

• Age > 18 years

Exclusion Criteria:

• Allogeneic transplantation scheduled as a part of the treatment

• High-dose melphalan with stem cell support scheduled as a part of the treatment

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

• Concurrent disease making clarithromycin or sulfamethoxazole/trimethoprim treatment unsuitable

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

• Known or suspected hypersensitivity or intolerance to claritromycin, sulfamethoxazole or trimethoprim

• Prolonged QT corrected (QTc) interval ( > 500 msec on screening ECG)

• Concurrent treatment with cabergoline, fluconazole, ketoconazole, pimozide, quetiapine, sirolimus, verapamil, tacrolimus, ergot alkaloid or methotrexate

• 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