Elotuzumab (Empliciti)
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General information
Class/mechanism: Monoclonal antibody that binds to SLAMF7 (CS1), a cell surface protein that is overly expressed on myeloma cells compared to normal cells.[1]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the package insert.
Preliminary data
Multiple myeloma
- Lonial S, Vij R, Harousseau JL, Facon T, Moreau P, Mazumder A, Kaufman JL, Leleu X, Tsao LC, Westland C, Singhal AK, Jagannath S. Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma. J Clin Oncol. 2012 Jun 1;30(16):1953-9. Epub 2012 Apr 30. PubMed
- Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Röllig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. Epub 2015 Jun 2. link to original article PubMed
Dexamethasone, Elotuzumab & Lenalidomide
Regimen, Richardson et al. 2012
Phase II
Note: the dose of elotuzumab reported here is that used in the ongoing phase III trials.
- Dexamethasone (Decadron) 40 mg PO once per week or 28 mg PO plus 8 mg IV on Elotuzumab (HuLuc63) dosing days
- Elotuzumab (HuLuc63) 20 mg/kg IV once on days 1, 8, 15, 22 of cycles 1 & 2, then once on days 1 & 15 of subsequent cycles
- Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
28-day cycles
References
- Abstract: Richardson, Paul G., Jagannath, Sundar, Moreau, Philippe, Jakubowiak, Andrzej, Raab, Marc S, Facon, Thierry, Vij, Ravi, White, Darrell J., Reece, Donna, Benboubker, Lotfi, Zonder, Jeffrey A., Deng, Wei, Kroog, Glenn, Singhal, Anil K, Lonial, Sagar. A Phase 2 Study of Elotuzumab (Elo) in Combination with Lenalidomide and Low-Dose Dexamethasone (Ld) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (R/R MM): Updated Results. ASH Annual Meeting Abstracts 2012 120: 202
Patient drug information
No information available.
History of changes in FDA indication
- 5/19/2014: Granted FDA Breakthrough Therapy designation "for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies."