Multiple myeloma MedDRA version: 18.0 Level: LLT Classification code 10021804 Term: Infection bacterial System Organ Class: 100000004862 MedDRA version: 16.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851
Conditions
Interventions
Product Name: Clarithromycin
Pharmaceutical Form: Tablet
Other descriptive name: CLARITHROMYCIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Product Name:
Sponsors
Department of Haematology, Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion 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 or biobanking, and skeletal x-ray • 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 280
Exclusion criteria
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 amyloi-dosis • Severe renal dysfunction (estimated creatinine clearance <10 mL/min) • Serious medical or psychiatric illness which, in the judgment of the investiga-tor, would make the patient inappropriate for entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observation;Secondary Objective: • To assess very good partial response and other markers of effect in the group of patients treated with clarithromycin compared to the other patients • To assess the tolerability of clarithromycin and sulfamethoxazole/trimethoprim combined with standard therapy in patients with newly diagnosed multiple myeloma • To estimate overall survival in the three treatment groups • To assess quality of life;Primary end point(s): To compare the frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observation. ;Timepoint(s) of evaluation of this end point: The statistical analysis of data will start in the autumn of 2016 when the last included patient has been followed for nine months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess very good partial response and other markers of effect in the group of patients treated with clarithromycin compared to the other patients To assess the tolerability of clarithromycin and sulfamethoxa-zole/trimethoprim combined with standard therapy in patients with newly diagnosed multiple myeloma. To estimate overall survival in the three treatment groups. To assess quality of life ;Timepoint(s) of evaluation of this end point: The statistical analysis of data will start in the autumn of 2016 when the last included patient has been followed for nine months after randomization | — |
Countries
Denmark
Contacts
Public ContactClinical Research Unit
Henrik Gregersen, Department of Haematology, Aalborg University Hospital
Outcome results
None listed