MedDataX Logo

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

NCT ID: NCT02624440

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clarithromycin

p.o. clarithromycin 250 mg twice daily for 180 days

Group Type EXPERIMENTAL

Standard myeloma treatment

Intervention Type DRUG

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

Intervention Type DRUG

P.o. clarithromycin 250 mg twice daily

Sulfamethoxazole/trimethoprim

p.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily for 180 days

Group Type EXPERIMENTAL

Standard myeloma treatment

Intervention Type DRUG

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

Sulfamethoxazole/trimethoprim

Intervention Type DRUG

P.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily

Observation

Observation without prophylactic antibiotic treatment

Group Type EXPERIMENTAL

Standard myeloma treatment

Intervention Type DRUG

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

Observation

Intervention Type DRUG

Observation without prophylactic antibiotic

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Clarithromycin

P.o. clarithromycin 250 mg twice daily

Intervention Type DRUG

Sulfamethoxazole/trimethoprim

P.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily

Intervention Type DRUG

Observation

Observation without prophylactic antibiotic

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Myeloma Study Group

OTHER

Sponsor Role collaborator

Henrik Gregersen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Henrik Gregersen

Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Henrik Gregersen, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Hematology, Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Department of Hematology, Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Department of Hematology, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Department of Hematology, Esbjerg Sygehus

Esbjerg, , Denmark

Site Status RECRUITING

Department of Hematology, Herlev Hospital

Herlev, , Denmark

Site Status RECRUITING

Department of Hematology, Hospitalsenheden Vest

Holstebro, , Denmark

Site Status RECRUITING

Department of Hematology, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Department of Hematology, Roskilde Hospital

Roskilde, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sanne Kjaer

Role: CONTACT

[email protected]
+45 97663884

Ulla Kjaer

Role: CONTACT

[email protected]
+45 97663882

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-004424-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DMSG#01/12

Identifier Type: -

Identifier Source: org_study_id