A phase 2 safety study of accelerated elotuzumab infusion, over less than 1 h, in combination with lenalidomide and dexamethasone, in patients with multiple myeloma
Autor: | Wael A. Harb, Hesham Mohamed, Ali Nourbakhsh, Robert M. Rifkin, James R. Berenson, Roger M. Lyons, Suprith Badarinath, Kristi McIntyre, Robert F. Manges, Alan Cartmell |
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Rok vydání: | 2017 |
Předmět: |
medicine.medical_specialty
Premedication Urology Phases of clinical research Antibodies Monoclonal Humanized Dexamethasone Drug Administration Schedule Ranitidine 03 medical and health sciences 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Elotuzumab Lenalidomide Multiple myeloma business.industry Diphenhydramine Hematology medicine.disease Thalidomide 030220 oncology & carcinogenesis Patient Safety Multiple Myeloma business 030215 immunology medicine.drug |
Zdroj: | American Journal of Hematology. 92:460-466 |
ISSN: | 1096-8652 0361-8609 |
DOI: | 10.1002/ajh.24687 |
Popis: | Elotuzumab, an immunostimulatory SLAMF7-targeting monoclonal antibody, induces myeloma cell death with minimal effects on normal tissue. In a previous phase 3 study in patients with relapsed/refractory multiple myeloma (RRMM), elotuzumab (10 mg/kg, ∼3-h infusion), combined with lenalidomide and dexamethasone, demonstrated durable efficacy and acceptable safety; 10% (33/321) of patients had infusion reactions (IRs; Grade 1/2: 29; Grade 3: 4). This phase 2 study (NCT02159365) investigated an accelerated infusion schedule in 70 patients with newly diagnosed multiple myeloma or RRMM. The primary endpoint was cumulative incidence of Grade 3/4 IRs by completion of treatment Cycle 2. Dosing comprised elotuzumab 10 mg/kg intravenously (weekly, Cycles 1-2; biweekly, Cycles 3+), lenalidomide 25 mg (daily, Days 1-21), and dexamethasone (28 mg orally and 8 mg intravenously, weekly, Cycles 1-2; 40 mg orally, weekly, Cycles 3+), in 28-day cycles. Premedication with diphenhydramine, acetaminophen, and ranitidine (or their equivalents) was given as in previous studies. If no IRs occurred, infusion rate was increased in Cycle 1 from 0.5 to 2 mL/min during dose 1 (∼2 h 50 min duration) to 5 mL/min for the entire infusion by dose 3 and also during all subsequent infusions (∼1-h duration). Median number of treatment cycles was six. No Grade 3/4 IRs occurred; only one Grade 1 and one Grade 2 IR occurred, both during the first infusion. These data support the safety of a faster infusion of elotuzumab administered over ∼1 h by the third dose, providing a more convenient alternative dosing option for patients. |
Databáze: | OpenAIRE |
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