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Trial record 24 of 398 for:    CLARITHROMYCIN

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

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ClinicalTrials.gov Identifier: NCT02624440
Recruitment Status : Unknown
Verified December 2015 by Henrik Gregersen, Aalborg University Hospital.
Recruitment status was:  Recruiting
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Danish Myeloma Study Group
Information provided by (Responsible Party):
Henrik Gregersen, Aalborg University Hospital

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Infection Drug: Standard myeloma treatment Drug: Clarithromycin Drug: Sulfamethoxazole/trimethoprim Drug: Observation Phase 2

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: Clarithromycin
p.o. clarithromycin 250 mg twice daily for 180 days
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

Experimental: Sulfamethoxazole/trimethoprim
p.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily for 180 days
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: Sulfamethoxazole/trimethoprim
P.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily

Experimental: Observation
Observation without prophylactic antibiotic treatment
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: Observation
Observation without prophylactic antibiotic




Primary Outcome Measures :
  1. Comparison of frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Response rates in the group of patients treated with clarithromycin compared to the other patients in the study [ Time Frame: One year ]
  2. Comparison of adverse events assessed by CTCAE v4.0 in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic [ Time Frame: 6 months ]
  3. Comparison of overall survival between patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic [ Time Frame: Three years ]
  4. Quality of life assessed by EORTC QLQ-MY20 [ Time Frame: One year ]
  5. Quality of life assessed by EORTC QLQ-C30 [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624440


Contacts
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Contact: Sanne Kjaer +45 97663884 smk@rn.dk
Contact: Ulla Kjaer +45 97663882 u.kjaer@rn.dk

Locations
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Denmark
Department of Hematology, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Principal Investigator: Henrik Gregersen, MD         
Department of Hematology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Niels Frost Andersen, MD         
Department of Hematology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Annette Juul Vangsted, MD         
Department of Hematology, Esbjerg Sygehus Recruiting
Esbjerg, Denmark, 6700
Principal Investigator: Per Trøllund Pedersen         
Department of Hematology, Herlev Hospital Recruiting
Herlev, Denmark, 2730
Principal Investigator: Carsten Helleberg, MD         
Department of Hematology, Hospitalsenheden Vest Recruiting
Holstebro, Denmark, 7500
Principal Investigator: Robert Schou Pedersen         
Department of Hematology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Principal Investigator: Niels Abildgaard, MD         
Department of Hematology, Roskilde Hospital Recruiting
Roskilde, Denmark, 4000
Principal Investigator: Ulf Christian Frølund, MD         
Sponsors and Collaborators
Henrik Gregersen
Danish Myeloma Study Group
Investigators
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Principal Investigator: Henrik Gregersen, MD Aalborg University Hospital

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Responsible Party: Henrik Gregersen, Consultant, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT02624440     History of Changes
Other Study ID Numbers: DMSG#01/12
2012-004424-38 ( EudraCT Number )
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by Henrik Gregersen, Aalborg University Hospital:
Multiple Myeloma
Infection
Clarithromycin
Trimethoprim-Sulfamethoxazole Combination
Additional relevant MeSH terms:
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Clarithromycin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
Trimethoprim
Sulfamethoxazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents