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

Sundar Jagannath, Jacob Laubach, Ellice Wong, Keith Stockerl-Goldstein, Cara Rosenbaum, Madhav Dhodapkar, Ying Ming Jou, Mark Lynch, Michael Robbins, Suresh Shelat, Kenneth C. Anderson, Paul G. Richardson

Research output: Contribution to journalArticlepeer-review

32 Scopus citations


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. CD56 dim (CD56 dim /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 CD56 dim 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 CD56 dim 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.

Original languageEnglish
Pages (from-to)495-503
Number of pages9
JournalBritish Journal of Haematology
Issue number4
StatePublished - Aug 2018


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


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