Elotuzumab in combination with thalidomide and low-dose dexamethasone: a phase 2 single-arm safety study in patients with relapsed/refractory multiple myeloma

Maria-Victoria Mateos, Miguel Granell, Albert Oriol, Joaquín Martínez-López, Joan Bladé, Miguel T Hernandez, Jesus Martín, Mercedes Gironella, Mark Lynch, Eric Bleickardt, Prashni Paliwal, Anil Singhal, Jesús San-Miguel, Torben Plesner (Medlem af forfattergruppering)

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Abstrakt

Elotuzumab is an immunostimulatory, humanized immunoglobulin G1 monoclonal antibody that selectively targets and kills signalling lymphocytic activation molecule family member 7-expressing myeloma cells. We evaluated the safety and tolerability of elotuzumab 10 mg/kg combined with thalidomide 50-200 mg and dexamethasone 40 mg (with/without cyclophosphamide 50 mg) in patients with relapsed/refractory multiple myeloma (RRMM). The primary endpoint was the proportion of grade ≥3 non-haematological adverse events (AEs); other endpoints included the number of dose reductions/discontinuations and efficacy. Forty patients were treated, who had a median of three previous therapies, including bortezomib (98%) and lenalidomide (73%). Grade ≥3 non-haematological AEs were reported in 63% of patients, most commonly asthenia (35%) and peripheral oedema (25%). Six (15%) patients had an infusion reaction. Twenty-six (65%) patients had ≥1 dose reduction/discontinuation due to an AE, none related to elotuzumab. Overall response rate was 38%; median progression-free survival was 3·9 months. Median overall survival was 16·3 months and the 1-year survival rate was 63%. Minimal incremental toxicity was observed with addition of elotuzumab to thalidomide/dexamethasone with or without cyclophosphamide, and efficacy data suggest clinical benefit in a highly pre-treated population. Elotuzumab combined with thalidomide may provide an additional treatment option for patients with RRMM.

OriginalsprogEngelsk
TidsskriftBritish Journal of Haematology
Vol/bind175
Udgave nummer3
Sider (fra-til)448-456
Antal sider9
ISSN0007-1048
DOI
StatusUdgivet - nov. 2016

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Citationsformater

Mateos, M-V., Granell, M., Oriol, A., Martínez-López, J., Bladé, J., Hernandez, M. T., Martín, J., Gironella, M., Lynch, M., Bleickardt, E., Paliwal, P., Singhal, A., San-Miguel, J., & Plesner, T. (2016). Elotuzumab in combination with thalidomide and low-dose dexamethasone: a phase 2 single-arm safety study in patients with relapsed/refractory multiple myeloma. British Journal of Haematology, 175(3), 448-456. https://doi.org/10.1111/bjh.14263