Clarithromycin, Sulfamethoxazole/Trimethoprim or Observation in Newly Diagnosed Multiple Myeloma
SUTRICA
A Randomized, Open-label Phase III Study of Clarithromycin, Sulfamethoxazole/Trimethoprim or Observation in Combination With Standard Therapy in Patients With Newly Diagnosed Multiple Myeloma
2 other identifiers
interventional
300
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Jan 2013
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 4, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedDecember 8, 2015
December 1, 2015
3.5 years
December 4, 2015
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic
One year
Secondary Outcomes (5)
Response rates in the group of patients treated with clarithromycin compared to the other patients in the study
One year
Comparison of adverse events assessed by CTCAE v4.0 in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic
6 months
Comparison of overall survival between patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic
Three years
Quality of life assessed by EORTC QLQ-MY20
One year
Quality of life assessed by EORTC QLQ-C30
One year
Study Arms (3)
Clarithromycin
EXPERIMENTALp.o. clarithromycin 250 mg twice daily for 180 days
Sulfamethoxazole/trimethoprim
EXPERIMENTALp.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily for 180 days
Observation
EXPERIMENTALObservation without prophylactic antibiotic treatment
Interventions
The choice of myeloma standard treatment is at the discretion of the treating investigator guided by the national Danish guidelines for treatment of multiple myeloma
P.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henrik Gregersenlead
- Danish Myeloma Study Groupcollaborator
Study Sites (8)
Department of Hematology, Aalborg University Hospital
Aalborg, 9000, Denmark
Department of Hematology, Aarhus University Hospital
Aarhus, 8000, Denmark
Department of Hematology, Rigshospitalet
Copenhagen, 2100, Denmark
Department of Hematology, Esbjerg Sygehus
Esbjerg, 6700, Denmark
Department of Hematology, Herlev Hospital
Herlev, 2730, Denmark
Department of Hematology, Hospitalsenheden Vest
Holstebro, 7500, Denmark
Department of Hematology, Odense University Hospital
Odense, 5000, Denmark
Department of Hematology, Roskilde Hospital
Roskilde, 4000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Gregersen, MD
Aalborg University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
December 4, 2015
First Posted
December 8, 2015
Study Start
January 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2017
Last Updated
December 8, 2015
Record last verified: 2015-12