Findings from a large clinical trial could pave the way for a new standard therapeutic approach to patients with refractory or relapsed and refractory multiple myeloma (RRMM) who have been failed by other treatment regimens.
With more than 85 participating sites across Europe, the open-label, phase 3b STRATUS trial was the largest of its kind to date to evaluate pomalidomide, an orally administered immunodulatory agent, plus low-dose dexamethasone in patients with RRMM.
Meletios Dimopoulous, MD, the first author of the study, presented safety and efficacy results of the pomalidomide and dexamethasone combination in 452 heavily pretreated patients; all patients had previously failed treatment with lenalidomide and bortezomib and had been treated with a median of five prior therapies.
The combination of pomalidomide and dexamethasone had no unexpected adverse events and was associated with progression-free survival and overall survival of 4.3 months and 10.9 months, respectively. The most common grade 3-4 treatment-emergent adverse events with the combination therapy were hematologic, and included neutropenia (39%), anemia (27%) and thromocytopenia (19%).
“This combination produced solid results, demonstrating that the combination is a standard of care for relapsed/refractory myeloma patients in whom lenalidomide and bortezomib therapies have failed,” said Dr. Dimopoulous.
He believes that findings from the phase 3b STRATUS trial, together with earlier smaller trials into the use of pomalidomide and dexamethasone in myeloma, should give treating practitioners the confidence they need to use the combination in patients who have relapsed or are refractory to bortezomib-based or lenalidomide-based regimens.
Dimopoulos MA, Palumbo A, Weisel K, et al. “Safety and efficacy in the Stratus (MM-010) trial, a single-arm phase 3b study evaluating pomalidomide + low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.” Abstract #80. Presented at the American Society of Hematology Annual Meeting, December 7, 2014.