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

NCT02624440 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-12-08

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

Clarithromycin

P.o. clarithromycin 250 mg twice daily

DRUG

Sulfamethoxazole/trimethoprim

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

DRUG

Observation

Observation without prophylactic antibiotic

Sponsors & Collaborators

  • Danish Myeloma Study Group

    collaborator OTHER

  • Henrik Gregersen

    lead OTHER

Principal Investigators

  • Henrik Gregersen, MD · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-07-31
Completion
2017-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624440 on ClinicalTrials.gov