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

Multiple Myeloma Clinical Trial

— SUTRICA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02624440
• Other study ID #: DMSG#01/12
• Secondary ID: 2012-004424-38
• Status: Recruiting
• Phase: Phase 2
• First received: December 4, 2015
• Last updated: December 4, 2015
• Start date: January 2013
• Est. completion date: July 2017

Study information

• Verified date: December 2015
• Source: Aalborg Universitetshospital
• Contact: Sanne Kjaer
• Phone: +45 97663884
• Email: smk[@]rn.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Description:

There is a need for improvement of the prognosis in elderly myeloma patients. The patients are fragile due to age and severe comorbidity. Infections are frequent during the course of initial myeloma treatment and contribute to the high morbidity and mortality in elderly patients. Furthermore infections often lead to delay in myeloma treatment and to dose reduction. The use of primary antibiotic prophylaxis might influence the frequency of these complications. In the study myeloma patients who are ineligible for high-dose melphalan with stem cell support are randomised to either p.o. clarithromycin 250 mg twice daily for 180 days, p.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily for 180 days or observation without prophylactic antibiotics. All patients receive concurrent myeloma treatment at the discretion of the treating physician. The choice of anti-myeloma treatment has to be settled before randomization. The study evaluates the frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Standard myeloma treatment
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
• Clarithromycin
P.o. clarithromycin 250 mg twice daily
• Sulfamethoxazole/trimethoprim
P.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily
• Observation
Observation without prophylactic antibiotic

Locations

Country	Name	City	State
Denmark	Department of Hematology, Aalborg University Hospital	Aalborg
Denmark	Department of Hematology, Aarhus University Hospital	Aarhus
Denmark	Department of Hematology, Rigshospitalet	Copenhagen
Denmark	Department of Hematology, Esbjerg Sygehus	Esbjerg
Denmark	Department of Hematology, Herlev Hospital	Herlev
Denmark	Department of Hematology, Hospitalsenheden Vest	Holstebro
Denmark	Department of Hematology, Odense University Hospital	Odense
Denmark	Department of Hematology, Roskilde Hospital	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Henrik Gregersen	Danish Myeloma Study Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic		One year	No
Secondary	Response rates in the group of patients treated with clarithromycin compared to the other patients in the study		One year	No
Secondary	Comparison of adverse events assessed by CTCAE v4.0 in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic		6 months	No
Secondary	Comparison of overall survival between patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic		Three years	No
Secondary	Quality of life assessed by EORTC QLQ-MY20		One year	No
Secondary	Quality of life assessed by EORTC QLQ-C30		One year	No