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

Primary Purpose

Multiple Myeloma, Infection

Status

Unknown status

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Standard myeloma treatment

Clarithromycin

Sulfamethoxazole/trimethoprim

Observation

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Infection, Clarithromycin, Trimethoprim-Sulfamethoxazole Combination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Hematology, Aalborg University HospitalRecruiting
Department of Hematology, Aarhus University HospitalRecruiting
Department of Hematology, RigshospitaletRecruiting
Department of Hematology, Esbjerg SygehusRecruiting
Department of Hematology, Herlev HospitalRecruiting
Department of Hematology, Hospitalsenheden VestRecruiting
Department of Hematology, Odense University HospitalRecruiting
Department of Hematology, Roskilde HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Clarithromycin

Sulfamethoxazole/trimethoprim

Observation

Arm Description

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

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

Observation without prophylactic antibiotic treatment

Outcomes

Primary Outcome Measures

Comparison of frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic

Secondary Outcome Measures

Response rates in the group of patients treated with clarithromycin compared to the other patients in the study

Comparison of adverse events assessed by CTCAE v4.0 in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic

Comparison of overall survival between patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic

Quality of life assessed by EORTC QLQ-MY20

Quality of life assessed by EORTC QLQ-C30

Full Information

NCT ID

NCT02624440

First Posted

December 4, 2015

Last Updated

December 4, 2015

Sponsor

Henrik Gregersen

Collaborators

Danish Myeloma Study Group

1. Study Identification

Unique Protocol Identification Number

NCT02624440

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Henrik Gregersen

Collaborators

Danish Myeloma Study Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma, Infection

Keywords

Multiple Myeloma, Infection, Clarithromycin, Trimethoprim-Sulfamethoxazole Combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clarithromycin

Arm Type

Experimental

Arm Description

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

Arm Title

Sulfamethoxazole/trimethoprim

Arm Type

Experimental

Arm Description

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

Arm Title

Observation

Arm Type

Experimental

Arm Description

Observation without prophylactic antibiotic treatment

Intervention Type

Drug

Intervention Name(s)

Standard myeloma treatment

Intervention Description

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

Intervention Name(s)

Clarithromycin

Intervention Description

P.o. clarithromycin 250 mg twice daily

Intervention Type

Drug

Intervention Name(s)

Sulfamethoxazole/trimethoprim

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Observation

Intervention Description

Observation without prophylactic antibiotic

Primary Outcome Measure Information:

Title

Comparison of frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic

Time Frame

One year

Secondary Outcome Measure Information:

Title

Response rates in the group of patients treated with clarithromycin compared to the other patients in the study

Time Frame

One year

Title

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

Title

Comparison of overall survival between patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic

Time Frame

Three years

Title

Quality of life assessed by EORTC QLQ-MY20

Time Frame

One year

Title

Quality of life assessed by EORTC QLQ-C30

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sanne Kjaer

Phone

+45 97663884

smk@rn.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Ulla Kjaer

Phone

+45 97663882

u.kjaer@rn.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik Gregersen, MD

Organizational Affiliation

Aalborg University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Hematology, Aalborg University Hospital

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henrik Gregersen, MD

Facility Name

Department of Hematology, Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niels Frost Andersen, MD

Facility Name

Department of Hematology, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Annette Juul Vangsted, MD

Facility Name

Department of Hematology, Esbjerg Sygehus

City

Esbjerg

ZIP/Postal Code

6700

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Per Trøllund Pedersen

Facility Name

Department of Hematology, Herlev Hospital

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carsten Helleberg, MD

Facility Name

Department of Hematology, Hospitalsenheden Vest

City

Holstebro

ZIP/Postal Code

7500

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Schou Pedersen

Facility Name

Department of Hematology, Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niels Abildgaard, MD

Facility Name

Department of Hematology, Roskilde Hospital

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulf Christian Frølund, MD

12. IPD Sharing Statement

Learn more about this trial

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

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