Clarithromycin in Multiple Myeloma Induction Therapy

Summary

This study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.

Timeline

Start

2015-01

Primary completion

2016-09

Completion

2016-09

Outcome

Missed primary endpoint

Stopped: “Suspected side effects to the combination of clarithromycin and VCD (bortezomib, cyclophosphamide and dexamethasone)”

paper 12 patients (44.4%, 95% CI 25.5-64.7) and in 16 patients (51.6%, 33.1-69.8) (p = 0.59) in the clarithromycin group and the placebo group, respectively. PMID 30123673 ↗

paper The response data do not suggest any effect of clarithromycin when added to the VCD regimen. PMID 30123673 ↗

Publications

• Background Gay 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.
• Nielsen 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.
• Gregersen 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clarithromycin	Small molecule	500 mg	Oral
Background	Bortezomib	Small molecule	1.3 mg/m2	Subcutaneous
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	40 mg	Oral

Indications