Adding Clarithromycin to Combination Therapy in Transplant-Ineligible Patients With Myeloma
Posted: Wednesday, April 8, 2020
The addition of the macrolide antibiotic clarithromycin to lenalidomide and dexamethasone may increase the rate and depth of responses for patients with newly diagnosed multiple melanoma who are not eligible for transplantation. However, the treatment does not seem to be correlated with improvements in survival over lenalidomide/dexamethasone alone, according to findings presented in the journal Blood. Noemi Puig, MD, PhD, of the Universitario de Salamanca, Spain, and colleagues observed a higher proportion of deaths among patients treated with clarithromycin plus lenalidomide/dexamethasone in the phase III GEM-Claridex trial, particularly for those older than age 75.
“Overexposure to steroids due to the delayed clearance induced by [clarithromycin] in this elderly population could explain our results,” the authors observed.
In this randomized trial, the authors enrolled 288 patients with untreated, newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplantation. Patients were treated with lenalidomide/dexamethasone alone (144 patients) or the standard care plus clarithromycin (144 patients) until disease progression or an unacceptable toxicity. The median age of those enrolled was 76.
The authors found that adding clarithromycin to the standard care corresponded with a complete response rate of at least 20.1%, compared with 11.2% in patients treated with lenalidomide/dexamethasone alone. Patients treated with clarithromycin also exhibited a very good partial response of 52.8%, whereas the rate in those given standard treatment was 37.1%.
After a median follow-up of 16 months, there were no “significant” differences in progression-free survival between those treated with or without clarithromycin (23 months vs. not reached, respectively). Notably, a trend toward shorter progression-free survival was found for those treated with clarithromycin, particularly patients aged 75 and older who experienced a significant detrimental effect on progression-free survival compared with those who received the standard treatment (19 months vs. 28 months).
Disclosure: For full disclosures of the study authors, visit ashpublication.org.
