Carfilzomib-Lenalidomide-Dexa, Lenalidomide in Smoldering, Newly Diagnosed Myeloma
Carfilzomib-lenalidomide-dexamethasone demonstrates high rates of minimal residual disease negativity in multiple myeloma.
Therapy with carfilzomib-lenalidomide-dexamethasone demonstrates high rates of minimal residual disease negativity in newly diagnosed multiple myeloma (NDMM), which equals longer progression-free survival in patients achieving MRD negativity.
The combination also demonstrates efficacy in high-risk smoldering multiple myeloma (SMM), according to an article published online ahead of print in the journal JAMA Oncology.
A clinical and correlative pilot study at the National Institutes of Health Clinical Center was performed to assess the safety and efficacy of carfilzomib-lenalindomide-dexamethasone therapy on NDMM and SMM. A total of 57 patients were enrolled (45 with NDMM, 12 high-risk SMM).
Patients received eight 28-day cycles of carfilzominb 20/36 mg/m2 on days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on days 1 through 21; and dexamethasone 20/10 mg (cycles 1-4/5-8) on days 1, 2, 8, 9, 15, 16, 22, and 23. Those who achieved at least stable response then received 24 cycles of extended lenalidomide. Median follow-up was 17.3 months for NDMM and 15.9 months for SMM.
None of the NDMM patients experienced grade 3 or higher neuropathy, one of the study's primary endpoints. All of the SMM patients experienced lymphopenia, and 92% experienced gastrointestinal disorders. All patients with SMM achieved at least a very good partial response rate.
Out of the 28 NDMM patients and the 12 SMM patients who achieved at least a near-complete response, MRD negativity was found in all NDMM patients, 92% in patients with SMM (multiparametric flow cytometry), 67% of 21 patients with NDMM, and 75% in 12 SMM patients (next-generation sequencing), respectively.