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Br J Haematol. 2018 Aug;182(4):495-503. doi: 10.1111/bjh.15384. Epub 2018 May 29.

Elotuzumab monotherapy in patients with smouldering multiple myeloma: a phase 2 study.

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The Tisch Cancer Institute, Mount Sinai Medical Center, New York, NY, USA.
Harvard Medical School, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, MA, USA.
Section of Medical Oncology, Department of Medicine, Yale University, New Haven, CT, USA.
Department of Medicine, VA Connecticut Healthcare System, West Haven, CT, USA.
Division of Oncology, Washington University, St Louis, MO, USA.
Division of Hematology and Medical Oncology, Weill Cornell Medicine, Cornell University, New York, NY, USA.
Section of Hematology, Department of Medicine, Yale University, New Haven, CT, USA.
Bristol-Myers Squibb, Princeton, NJ, USA.


Smouldering multiple myeloma (SMM) is associated with increased risk of progression to multiple myeloma within 2 years, with no approved treatments. Elotuzumab has been shown to promote natural killer (NK) cell stimulation and antibody-dependent cellular cytotoxicity (ADCC) in vitro. CD56dim (CD56dim /CD16+ /CD3- /CD45+ ) NK cells represent the primary subset responsible for elotuzumab-induced ADCC. In this phase II, non-randomized study (NCT01441973), patients with SMM received elotuzumab 20 mg/kg intravenously (cycle 1: days 1, 8; monthly thereafter) or 10 mg/kg (cycles 1, 2: weekly; every 2 weeks thereafter). The primary endpoint was the relationship between baseline proportion of bone marrow-derived CD56dim NK cells and maximal M protein reduction; secondary endpoints included overall response rate (ORR) and progression-free survival (PFS). Fifteen patients received 20 mg/kg and 16 received 10 mg/kg; combined data arepresented. At database lock (DBL, September 2014), no association was found between baseline CD56dim NK cell proportion and maximal M protein reduction. With minimum 28 months' follow-up (DBL: January 2016), ORR (90% CI) was 10% (2·7-23·2) and 2-year PFS rate was 69% (52-81%). Upper respiratory tract infections occurred in 18/31 (58%) patients. Four (13%) patients experienced infusion reactions, all grade 1-2. Elotuzumab plus lenalidomide/dexamethasone is under investigation for SMM.


elotuzumab; monoclonal antibody; multiple myeloma; natural killer cells; smouldering multiple myeloma

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