Selinexor, bortezomib, and dexamethasone (SVD) in heavily treated relapsed refractory multiple myeloma
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LETTER TO THE EDITOR
Selinexor, bortezomib, and dexamethasone (SVD) in heavily treated relapsed refractory multiple myeloma Tarek H. Mouhieddine 1 & Samir Parekh 2 & Hearn Jay Cho 2 & Joshua Richter 2 & Andrew DeCastro 3 & Jatin Shah 3 & Yosef Landesman 3 & Ajai Chari 2 & Sundar Jagannath 2 & Deepu Madduri 2 Received: 12 September 2020 / Accepted: 28 September 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Dear Editor, Multiple myeloma (MM) is a plasma cell dyscrasia that eventually becomes refractory to all available therapies. This is accompanied by progressive organ dysfunction and performance status decline in patients, making them ineligible for enrollment in clinical trials offering novel approaches. Mounting evidence is showing the significance of exportin-1 (XPO-1) across multiple malignancies, especially MM [1–3], leading to the conduction of multiple clinical trials [4–6]. Recently, the preliminary data of the phase 3, randomized, open-label multicenter BOSTON trial of selinexor, bortezomib, and dexamethasone (SVD) vs. bortezomib and dexamethasone in 402 patients [7] showed a significant improvement in median progression-free survival (PFS): 13.93 vs 9.46 months (HR 0.70, p = 0.0066), respectively. We enrolled 8 relapsed refractory MM (RRMM) patients who had exhausted their treatment options and were progressing on their last line of therapy to receive SVD as part of a compassionate use program. The reasons for not being eligible for trials varied from low creatinine clearance to chronic cytopenias, medical instability, and leptomeningeal disease. The dosing schedule was based on the BOSTON trial regimen: weekly selinexor 100 mg, subcutaneous bortezomib 1.3 mg/m2 for 4 out of 5 weeks, and dexamethasone 40 mg7. The patients were enrolled at the Tisch Cancer Institute, The
* Deepu Madduri [email protected] 1
Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
2
Department of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, 10 East 102nd Street, 6th Floor, New York, NY 10029, USA
3
Karyopharm Therapeutics, Newton, MA 02459, USA
Mount Sinai Hospital, New York, between April 2019 and June 2019. The median age of patients was 62 years (range: 57–76) with a 1:1 female to male ratio (Table 1). All patients were heavily treated with a median of 11 prior lines of therapy (range: 6–18) and 6 out of 8 carried high-risk cytogenetics. All patients were exposed or refractory to immunomodulators, proteasome inhibitors, and daratumumab and underwent at least one autologous stem cell transplant. Best responses included 1 complete response (CR), 1 very good partial response (VGPR), 2 partial response (PR), 3 stable disease (SD), and 1 progressive disease (PD). The patients’ median PFS was 91 days (range: 58–350), while the overall survival was 300 days (range: 68–376). Four patients had extramedullary disease, including plasma cell leukemia with leptomeningeal involvement, and 2/4 patients had a PR. One patient w
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