Academic Journal
S1606 SAFETY AND EFFICACY OF COMBINATION OF SELINEXOR, DARATUMUMAB, AND DEXAMETHASONE (SDD) IN PATIENTS WITH MULTIPLE MYELOMA (MM) PREVIOUSLY EXPOSED TO PROTEASOME INHIBITORS AND IMMUNOMODULATORY DRUGS
| العنوان: | S1606 SAFETY AND EFFICACY OF COMBINATION OF SELINEXOR, DARATUMUMAB, AND DEXAMETHASONE (SDD) IN PATIENTS WITH MULTIPLE MYELOMA (MM) PREVIOUSLY EXPOSED TO PROTEASOME INHIBITORS AND IMMUNOMODULATORY DRUGS |
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| المؤلفون: | Gasparetto, C., Lentzsch, S., Schiller, G., Callander, N., Tuchman, S., Chen, C., White, D., Kotb, R., Sutherland, H., Sebag, M., Baljevic, M., Bensinger, W., LeBlanc, R., Venne, C., Bahlis, N., Rodriguez‐Lopez, K., Sheehan, H., Saint‐Martin, J.‐R., Shah, J., Shacham, S., Kauffman, M., Lipe, B. |
| المصدر: | HemaSphere ; volume 3, issue S1, page 740 ; ISSN 2572-9241 2572-9241 |
| بيانات النشر: | Wiley |
| سنة النشر: | 2019 |
| المجموعة: | Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: | Background: Selinexor is a first‐in‐class Selective Inhibitor of Nuclear Export (SINE) compound that binds and inactivates Exportin 1 (XPO1). Selinexor in combination with dexamethasone (dex) has demonstrated a 26.2% overall response rate (ORR) in patients (pts) with triple‐class refractory myeloma (defined as refractory to an immunomodulatory drug (IMiD), proteasome inhibitor (PI), and CD‐38 monoclonal antibody [mAb]) including deep responses with very good partial response (VGPR) and 2 pts in a stringent complete response (sCR) (minimal residual disease negative). Daratumumab (Dara), an anti‐CD38 mAb, is approved for the treatment of heavily pretreated MM is limited by short progression‐free survival (PFS) and an ORR of ∼21% in quad‐refractory MM. Aims: The objectives of the study were to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), and to assess the safety, tolerability, and preliminary efficacy of the combination of SDd in pts with PI/IMiD refractory MM. Methods: This is amulticenter, open‐label, phase 1/2b study with a dose escalation and expansion phase.Pts were eligible if they had received ≥3 prior lines of anti‐myeloma therapy, including a PI and an IMiD or whose MM is refractory to a PI and IMiD. In the expansion phase, pts’ prior dara therapy was exclusionary. Selinexor was dose‐escalated in 2 concurrent cohorts: once‐weekly (QW, at 100 mg) or twice‐weekly (BIW, at 60 mg). Dara was administered at 16 mg/kg IV (recommended schedule) and dex at 40 mg QW or 20 mg BIW. In the expansion phase, pts were to receive the RP2D. Results: As of February 20 th 2019, 30 pts (16 male/14 female) have been enrolled. Three pts have been enrolled into the 60 mg BIW and 27 pts in the 100 mg QW cohorts. The median age was 69 years and the median number of prior treatment regimens was 3 (range, 2 – 10). Common treatment‐related adverse events (all grades, Grades 3/4) included: thrombocytopenia (66%, 48%), nausea (66%, 3%), fatigue (55%, 14%), anemia (52%, 31%), leukopenia (48%, 31%), and ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1097/01.hs9.0000564672.91201.a6 |
| DOI: | 10.1097/01.HS9.0000564672.91201.a6 |
| الاتاحة: | http://dx.doi.org/10.1097/01.hs9.0000564672.91201.a6 https://onlinelibrary.wiley.com/doi/pdf/10.1097/01.HS9.0000564672.91201.a6 |
| Rights: | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| رقم الانضمام: | edsbas.66F13894 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1097/01.hs9.0000564672.91201.a6 |
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