Clinical trial · Interventional
Clarithromycin, Sulfamethoxazole/Trimethoprim or Observation in Newly Diagnosed Multiple Myeloma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infection | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clarithromycin | Drug | — | UNRESOLVED |
| Observation | Drug | — | UNRESOLVED |
| Standard myeloma treatment | Drug | — | UNRESOLVED |
| Sulfamethoxazole/trimethoprim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Clarithromycin
- description
- p.o. clarithromycin 250 mg twice daily for 180 days
- interventionNames
- Drug: Standard myeloma treatment
- Drug: Clarithromycin
- type
- EXPERIMENTAL
- label
- Sulfamethoxazole/trimethoprim
- description
- p.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily for 180 days
- interventionNames
- Drug: Standard myeloma treatment
- Drug: Sulfamethoxazole/trimethoprim
- type
- EXPERIMENTAL
- label
- Observation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available