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Clin Cancer Res. 2020 Jan 14;:
Authors: Berenson JR, To J, Spektor TM, Martinez D, Turner C, Sanchez A, Ghermezi M, Eades BM, Swift RA, Schwartz G, Eshaghian S, Stampleman L, Moss RA, Lim S, Vescio R
Abstract
PURPOSE: This Phase I trial evaluated the safety and efficacy of a novel, all-oral combination consisting of the JAK 1/2 inhibitor ruxolitinib (RUX), lenalidomide (LEN) and steroids for treating relapsed/refractory multiple myeloma patients. Many newer drugs have been evaluated together and in combination with older agents for these patients but the responses to these regimens including those containing immunomodulatory agents are transient; and, thus, new therapeutic approaches to help overcome resistance to immunomodulatory agents are needed.
EXPERIMENTAL DESIGN: A traditional 3+3 dose-escalation design was used to enroll subjects in four cohorts with a planned total enrollment of 28 patients. Subjects received ruxolitinib (RUX) twice daily, lenalidomide (LEN) daily on days 1‑21 of a 28-day cycle and methylprednisolone (MP) orally every other day. Primary endpoints were safety, clinical benefit rate (CBR) and overall response rate (ORR).
RESULTS: Twenty-eight patients were enrolled. The median age was 67 years and received a median of 6 prior treatments including LEN and steroids to which 93% were refractory. No DLTs occurred. The CBR and ORR were 46% and 38%, respectively. All 12 responding pts were refractory to LEN. G3 or G4 AEs included anemia (18%), thrombocytopenia (14%) and lymphopenia (14%). Most common SAEs included sepsis (11%) and pneumonia (11%).
CONCLUSIONS: This study provides the basis for studying the addition of JAK inhibitors to improve the efficacy of immunomodulatory agents with steroids for treating myeloma patients but perhaps can also be expanded for treating other cancer patients that are refractory to this class of drugs.
PMID: 31937615 [PubMed - as supplied by publisher]
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