Clinical trial · Interventional
Clarithromycin in Multiple Myeloma Induction Therapy
A Randomized Placebo-controlled Phase II Study of Clarithromycin or Placebo Combined With VCD Induction Therapy Prior to High-dose Melphalan With Stem Cell Support in Patients With Newly Diagnosed Multiple Myeloma
NCT02573935CI-TRIAL-00023952CLAIMterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Suspected side effects to the combination of clarithromycin and VCD (bortezomib, cyclophosphamide and dexamethasone)
Summary
Brief summary (as posted)
This study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clarithromycin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| VCD induction therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Clarithromycin
- description
- Clarithromycin combined with VCD induction therapy
- interventionNames
- Drug: Clarithromycin
- Drug: VCD induction therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo combined with VCD induction therapy
- interventionNames
- Drug: Placebo
- Drug: VCD induction therapy
Primary outcomes (1)
- measure
- Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo
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 * High-dose melphalan with stem cell support scheduled as a part of the treatment * Signed informed consent given prior to any study related activities * Age \> 18 years Exclusion Criteria: * Allogeneic transplantation scheduled as a part of the treatment * Myeloma treatment prior to entry in the study, except radiotherapy, bisphosphonates/denosumab or corticosteroids for symptom control * Concurrent disease making clarithromycin treatment unsuitable * Positive pregnancy test (only applicable for women with childbearing potential) * Known or suspected hypersensitivity or intolerance to clarithromycin * Prolonged QT corrected (QTc) interval ( \> 500 msec on screening ECG) * Concurrent treatment with cabergoline, fluconazole, ketoconazole, pimozide, quetiapine, sirolimus, verapamil, tacrolimus, ergot alkaloid, simvastatin or other statins * 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 (3)
- BACKGROUNDGay F, Rajkumar SV, Coleman M, Kumar S, Mark T, Dispenzieri A, Pearse R, Gertz MA, Leonard J, Lacy MQ, Chen-Kiang S, Roy V, Jayabalan DS, Lust JA, Witzig TE, Fonseca R, Kyle RA, Greipp PR, Stewart AK, Niesvizky R. Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma. Am J Hematol. 2010 Sep;85(9):664-9. doi: 10.1002/ajh.21777. PMID 20645430
- DERIVEDNielsen LK, Klausen TW, Jarden M, Frederiksen H, Vangsted AJ, Do T, Kristensen IB, Frolund UC, Andersen CL, Abildgaard N, Gregersen H. Clarithromycin added to bortezomib-cyclophosphamide-dexamethasone impairs health-related quality of life in multiple myeloma patients. Eur J Haematol. 2019 Jan;102(1):70-78. doi: 10.1111/ejh.13175. Epub 2018 Oct 29. PMID 30230047
- DERIVEDGregersen H, Do T, Kristensen IB, Frolund UC, Andersen NF, Nielsen LK, Andersen CL, Klausen TW, Vangsted AJ, Abildgaard N. A randomized placebo-controlled phase II study of clarithromycin or placebo combined with VCD induction therapy prior to high-dose melphalan with stem cell support in patients with newly diagnosed multiple myeloma. Exp Hematol Oncol. 2018 Aug 13;7:18. doi: 10.1186/s40164-018-0110-0. eCollection 2018. PMID 30123673