Site Editors
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Thursday, May 26, 2022
Findings from the phase II MARCH trial—designed to address Chinese regulatory needs to validate the previous STORM global trial—determined that treatment with selinexor in combination with dexamethasone may have a clinical benefit for Chinese patients with heavily treated, highly refractory multiple myeloma, according to results presented in BMC Medicine. Lugui Qiu, MD, of the Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, and colleagues concluded that treatment with the selective inhibitor of nuclear transport (SINE) plus dexamethasone demonstrated efficacy with a manageable safety profile in this patient population.
“The combination of selinexor and low-dose dexamethaone was approved by the U.S. Food and Drug Administration based on safety and efficacy data from the STORM study,” the investigators noted. “In view of the outcomes in the STORM study, we initiated MARCH, a bridging study in China with a similar study design....”
The MARCH study was conducted at 17 sites in China and included 82 patients with relapsed or refractory multiple myeloma. They had previously received both a proteasome inhibitor and an immunomodulatory agent; 20 patients had triple-class–refractory disease. Patients were treated with 80 mg of selinexor combined with 20 mg of dexamethasone twice weekly in 4-week cycles. Of the population, 55 had high-risk cytogenetic abnormalities, defined as one or more del(17p13), t(4;14), t(14;16), or 1q amplification identified by fluorescence in situ hybridization.
The overall response rate among all treated patients was 29.3%, with a median duration of response of 4.7 months. The median progression-free survival was 3.7 months, and the overall survival was 13.2 months. Among the triple-class–refractory population, the overall response rate was 25%. Serious adverse events were reported in 54.9% of patients.
Disclosure: For full disclosures of the study authors, visit bmcmedicine.com.
