Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma

Summary

PRIMARY STUDY OBJECTIVES * To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM). * To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM. SECONDARY STUDY OBJECTIVES * To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide. * To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.

Timeline

Start

2004-12

Primary completion

2007-04

Completion

2020-09-29

Publications

• Rossi A, Mark T, Jayabalan D, Christos P, Zafar F, Pekle K, Pearse R, Chen-Kiang S, Coleman M, Niesvizky R. BiRd (clarithromycin, lenalidomide, dexamethasone): an update on long-term lenalidomide therapy in previously untreated patients with multiple myeloma. Blood. 2013 Mar 14;121(11):1982-5. doi: 10.1182/blood-2012-08-448563. Epub 2013 Jan 8.
• Niesvizky R, Jayabalan DS, Christos PJ, Furst JR, Naib T, Ely S, Jalbrzikowski J, Pearse RN, Zafar F, Pekle K, Larow A, Lent R, Mark T, Cho HJ, Shore T, Tepler J, Harpel J, Schuster MW, Mathew S, Leonard JP, Mazumdar M, Chen-Kiang S, Coleman M. BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma. Blood. 2008 Feb 1;111(3):1101-9. doi: 10.1182/blood-2007-05-090258. Epub 2007 Nov 7.

Drugs

Indications