Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
10 participants
INTERVENTIONAL
2014-03-31
2014-12-31
Brief Summary
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Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Lactobacillus brevis CD2 lozenges
Lactobacillus brevis CD2
Interventions
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Lactobacillus brevis CD2
Eligibility Criteria
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Inclusion Criteria
* Karnofsky Performance Score ≥ 70%.
* Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy
* Patients eligible to receive high-dose chemotherapy as part of conditioning regimen
* Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)
* Serum creatinine \< 1.8mg/dl
* Total bilirubin \< 2mg/dl
* Liver enzymes within three times of normal limit
* Expected survival \> 6 months.
Exclusion Criteria
* Patients with history of HIV infection
* Patients who have taken any other investigational product in last 4 weeks
* Patients having untreated symptomatic dental infection
* Patients with WHO Grade 3 or 4 oral Mucositis
* Other serious concurrent illness
* Inconclusive hematological diagnosis
* Patients with signs and symptoms of systemic infections
* Patient's/guardian's refusal to sign informed consent
18 Years
65 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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sabrina giammarco
MD
Locations
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Policlinico Universitario "A. GEMELLI"
Rome, Rome, Italy
Countries
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Facility Contacts
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Other Identifiers
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001/14
Identifier Type: -
Identifier Source: org_study_id
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