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Pomalidomide plus low-dose dexamethasone shows promise for relapsed, refractory multiple myeloma
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NEW YORK — The combination of pomalidomide plus low-dose dexamethasone demonstrated a greater survival benefit than other available treatments among patients with relapsed and refractory multiple myeloma, according to an analysis of real-world data presented at Lymphoma & Myeloma 2015.
The combination of pomalidomide (Pomalyst, Celgene) and low-dose dexamethasone has previously demonstrated a significant benefit compared with high-dose dexamethasone, according to study background.
In the absence of direct comparative studies, Hartmut Goldschmidt, MD, PhD, of University of Heidelberg in Germany, and colleagues used statistical analyses on time-to-event individual patient data to estimate the comparative effectiveness of pomalidomide plus low-dose dexamethasone vs. other available treatments. Researchers also used standard extrapolation methods to compare long-term OS outcomes.
The analysis included individual patient data derived from 56 patients receiving active treatment in the United Kingdom, France, Spain, Italy and Germany. Patients primarily received bendamustine (Treanda, Cephalon) and bortezomib (Velcade; Takeda Oncology, Millennium) combinations.
Researchers compared these data with individual patient data from 415 patients who received pomalidomide plus low-dose dexamethasone on the MM-002 and MM-003 trials.
The time-to-event regression model included eight covariates: age, disease duration, International Staging System stage, receipt of thalidomide (Thalomid, Celgene), stem cell transplant, bortezomib refractory, lenalidomide (Revlimid, Celgene) refractory and treatment.
Results of analyses adjusted for baseline patient demographics showed pomalidomide and low-dose dexamethasone conferred longer median survival compared with other treatments (14.4 months vs. 4.6 months). Patients who received pomalidomide and low-dose dexamethasone appeared to have a reduced risk for death (HR = 0.33; 95% CI, 0.18-0.59).
When researchers used a log-normal curve to evaluate these data, the median survival benefit appeared even greater with pomalidomide and low-dose dexamethasone compared with other treatments (28.7 vs. 9.6 months). This analysis produced the lowest Akaike information criterion and Bayesian information criterion values.
Researchers noted limitations of these data include that randomization was not preserved because data originated from different centers and the small sample size.
“In this analysis, pomalidomide plus low-dose dexamethasone showed greater survival prospects than other active treatments with the predicted median remaining in line with published estimates for patients in this hard-to-treat group treated with both lenalidomide and bortezomib,” Goldschmidt and colleagues wrote. – by Alexandra Todak
Reference:
Goldschmidt H, et al. Abstract P8. Presented at: Lymphoma & Myeloma 2015; Oct. 22-24, 2015; New York, New York.
Disclosure: The researchers report no relevant financial disclosures.