Multiple MyelomaPhase 2SUTRICANCT02624440
Clarithromycin, Sulfamethoxazole/Trimethoprim or Observation in Newly Diagnosed Multiple Myeloma
A Phase 2 study testing Standard myeloma treatment, Clarithromycin and Sulfamethoxazole/trimethoprim in people with Multiple Myeloma and Infection, run by Henrik Gregersen at 8 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Infection
- What is being tested?
- Standard myeloma treatment, Clarithromycin and Sulfamethoxazole/trimethoprim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 8 sitesDenmark
- Study dates
- Jan 2013to Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites, 8 recruiting
- Recruiting
Department of Hematology, Aalborg University Hospital
Aalborg, 9000
Henrik Gregersen, MD
- Recruiting
Department of Hematology, Aarhus University Hospital
Aarhus, 8000
Niels Frost Andersen, MD
- Recruiting
Department of Hematology, Rigshospitalet
Copenhagen, 2100
Annette Juul Vangsted, MD
- Recruiting
Department of Hematology, Esbjerg Sygehus
Esbjerg, 6700
Per Trøllund Pedersen
- Recruiting
Department of Hematology, Herlev Hospital
Herlev, 2730
Carsten Helleberg, MD
- Recruiting
Department of Hematology, Hospitalsenheden Vest
Holstebro, 7500
Robert Schou Pedersen
- Recruiting
Department of Hematology, Odense University Hospital
Odense, 5000
Niels Abildgaard, MD
- Recruiting
Department of Hematology, Roskilde Hospital
Roskilde, 4000
Ulf Christian Frølund, MD
About this study
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
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.
Read the 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
- Conditions
- Multiple Myeloma, Infection
- Being tested
- Standard myeloma treatment, Clarithromycin, Sulfamethoxazole/trimethoprim, Observation
- Keywords
- Multiple Myeloma, Infection, Clarithromycin, Trimethoprim-Sulfamethoxazole Combination
- Medical subject headings
- Multiple Myeloma, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard myeloma treatmentDrug
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
ClarithromycinDrug
P.o. clarithromycin 250 mg twice daily
Sulfamethoxazole/trimethoprimDrug
P.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily
ObservationDrug
Observation without prophylactic antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin | Experimental | p.o. clarithromycin 250 mg twice daily for 180 days Receives: Drug: Standard myeloma treatment; Drug: Clarithromycin |
| Sulfamethoxazole/trimethoprim | Experimental | p.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily for 180 days Receives: Drug: Standard myeloma treatment; Drug: Sulfamethoxazole/trimethoprim |
| Observation | Experimental | Observation without prophylactic antibiotic treatment Receives: Drug: Standard myeloma treatment; Drug: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic
Measured: One year
Secondary outcomes (5)
Response rates in the group of patients treated with clarithromycin compared to the other patients in the study
Measured: One year
Comparison of adverse events assessed by CTCAE v4.0 in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic
Measured: 6 months
Comparison of overall survival between patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic
Measured: Three years
Quality of life assessed by EORTC QLQ-MY20
Measured: One year
Quality of life assessed by EORTC QLQ-C30
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJan 2013
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Gregersen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Myeloma Study Group
- Responsible party
- Sponsor-investigator, Henrik Gregersen, Aalborg University Hospital
- Investigators
- Henrik Gregersen, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624440
- Sponsor's protocol ID
- DMSG#01/12
- Other IDs
- 2012-004424-38
- Acronym
- SUTRICA
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2015
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02624440
- Acronym / sponsor ID
- SUTRICA / DMSG#01/12
- Conditions
- Multiple Myeloma, Infection
- Keywords
- Multiple Myeloma, Infection, Clarithromycin, Trimethoprim-Sulfamethoxazole Combination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Henrik GregersenUniversity, hospital or other
- Collaborators
- Danish Myeloma Study Group
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin | Experimental | Drug: Standard myeloma treatment, Drug: Clarithromycinp.o. clarithromycin 250 mg twice daily for 180 days |
| Sulfamethoxazole/trimethoprim | Experimental | Drug: Standard myeloma treatment, Drug: Sulfamethoxazole/trimethoprimp.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily for 180 days |
| Observation | Experimental | Drug: Standard myeloma treatment, Drug: ObservationObservation without prophylactic antibiotic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard myeloma treatmentThe 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, Observation, Sulfamethoxazole/trimethoprim |
| ClarithromycinP.o. clarithromycin 250 mg twice daily | Drug | Clarithromycin |
| Sulfamethoxazole/trimethoprimP.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily | Drug | Sulfamethoxazole/trimethoprim |
| ObservationObservation without prophylactic antibiotic | Drug | Observation |
Primary outcome
Comparison of frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic
Time frame: One year
5 secondary outcomes
Response rates in the group of patients treated with clarithromycin compared to the other patients in the study
Time frame: One year
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
Comparison of overall survival between patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic
Time frame: Three years
Quality of life assessed by EORTC QLQ-MY20
Time frame: One year
Quality of life assessed by EORTC QLQ-C30
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Gregersen, MD principal investigator
Aalborg University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard myeloma treatment, Clarithromycin and Sulfamethoxazole/trimethoprim in people with Multiple Myeloma and Infection, run by Henrik Gregersen at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanne Kjaer (+45 97663884, smk@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of frequency of infections in patients treated with clarithromycin, sulfamethoxazole/trimethoprim or observed without prophylactic antibiotic (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.