Pomalidomide plus low-dose dexamethasone should be a standard of care for patients with relapsed/refractory multiple myeloma who have a poor prognosis, a study published in Blood suggests.1
Because patients with relapsed/refractory multiple myeloma (RRMM) have poor prognosis, researchers sought to evaluate the efficacy and safety of pomalidomide with low-dose dexamethasone in a large cohort of patients with relapsed/refractory disease.
For the phase 3b STRATUS™ trial, investigators enrolled 682 patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy. Median age was 66 years and median time since myeloma diagnosis was 5.3 years. The median number of prior regimens was 5 and 80.2% of patients were refractory to both lenalidomide and bortezomib.
All participants received pomalidomide 4 mg orally on days 1 to 21 of each 28-day cycle plus dexamethasone 40 mg (20 mg for patients 75 years or older) on days 1, 8, 15, and 22 until disease progression or unacceptable toxicity.
The overall response rate was 32.6% with a median duration of response of 7.4 months. Median progression-free survival and overall survival were 4.6 months and 11.9 months, respectively.
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The most common grade 3 or 4 treatment-emergent adverse events were neutropenia (49.7%), anemia (33.0%), and thrombocytopenia (24.1%). The most frequently reported grade 3 or 4 nonhematologic adverse events were pneumonia (10.9%) and fatigue (5.9%). Grade 3 or 4 venous thromboembolism and peripheral neuropathy occurred rarely, with 1.6% of patients experiencing each.
The findings suggest that this regimen is clinically beneficial and often well tolerated.
- Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, et al.. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUSTM (MM-010): a phase 3b study in refractory multiple myeloma [published online ahead of print May 25, 2016]. Blood. doi: 10.1182/blood-2016-02-700872.