Rebecca Araujo

DocwireNews

Clarithromycin plus lenalidomide and dexamethasone for the treatment of multiple myeloma (MM) did not offer a survival benefit compared with standard treatment, according to a phase 3 trial.&ldquo;Although case-control analyses have suggested an additive value with the association of clarithromycin to continuous lenalidomide and dexamethasone, there are not phase 3 trials confirming these results,&rdquo; wrote the study authors. The findings from this trial were published in <a href="https://www.nature.com/articles/s41408-021-00490-8">Blood Cancer Journal.</a><h2>Clarithromycin for Multiple Myeloma</h2>Clarithromycin is an antibiotic previously found to have immunomodulatory properties, according to the authors. The investigators tested this drug in the multi-center, open label GEM-CLARIDEX trial, which enrolled 286 patients aged &ge;65 years with newly diagnosed MM who were ineligible for <a href="https://www.docwirenews.com/condition-center/multiple-myeloma-knowledge-hub/supporting-bone-health-in-patients-receiving-stem-cell-transplant/">autologous hematopoietic cell transplantation (AHCT)</a>.Patients were randomized 1:1 to the all-oral regimen of clarithromycin plus lenalidomide 25 mg and dexamethasone 40 mg (C-Rd) or lenalidomide and dexamethasone alone (Rd). Clarithromycin was dosed at 500 mg per 12 hours continuously. Reduced doses of Rd were administered to patients with impaired creatinine clearance or patients aged &ge;75 years, respectively. Treatment continued until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival, and secondary endpoints included response rates and duration, time to disease progression, overall survival, and safety and tolerability.Median follow-up was 19 months. At time of data cutoff, three-quarters of patients in the C-Rd group and 57.3% of patients in the Rd group had discontinued treatment. Progressive disease was the most common reason for treatment discontinuation (C-Rd, 31.4%; Rd, 12.2%). Median duration for C-Rd was 15.0 months (range, 0.2&ndash;44), compared with 15.9 months (range, 0.4&ndash;46) for Rd.<h2>No PFS Benefit for C-Rd Versus Rd</h2>At median follow-up, disease progression or death occurred in 49.6% of patients (n = 71) in the C-Rd group and 42.6% of the Rd group (n = 61). Median PFS in the C-Rd versus Rd groups was 23 months (95% confidence interval [CI], 15.3&ndash;30.6) and 29 months (95% CI, 22.4&ndash;35.5), respectively. The hazard ratio for disease progression or mortality in the clarithromycin group was 1.293 (95% CI, 0.92&ndash;1.82, P&thinsp;=&thinsp;0.14).The overall response rate to C-Rd and Rd was 71.5% and 76.4%, respectively. More patients in the C-Rd group achieved a complete response (CR) or better compared to the Rd group (22.6% vs. 14.4%, P&thinsp;=&thinsp;0.048). There was no significant differences in minimal residual disease (MRD) negativity between groups.The most common grade &ge;3 adverse events (AEs) were neutropenia and infections. Rates of AEs were similar between groups, however death due to toxicity was more common in the C-Rd group compared with the control (72% vs. 55% of deaths; P = 0.09).In conclusion, the authors wrote, &ldquo;The addition of clarithromycin to Rd in untreated transplant-ineligible [patients with] MM does not improve PFS despite increasing the &ge;CR rate due to the higher number of toxic deaths in the C-Rd arm. Side effects related to overexposure to steroids due to its delayed clearance induced by clarithromycin in this elderly population could explain these results.&rdquo;

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Clarithromycin plus lenalidomide and dexamethasone for the treatment of multiple myeloma (MM) did not offer a survival benefit compared with standard treatment, according to a ...

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