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Br J Haematol. 2017 Mar;176(5):783-795. doi: 10.1111/bjh.14483. Epub 2016 Dec 22.

Phase 2 study of tabalumab, a human anti-B-cell activating factor antibody, with bortezomib and dexamethasone in patients with previously treated multiple myeloma.

Author information

1
Massachusetts General Hospital, Boston, MA, USA.
2
University Hospital Hôtel-Dieu, Nantes, France.
3
National and Kapodistrian University of Athens School of Medicine, Athens, Greece.
4
Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.
5
Medical University of Lublin and Department of Haematology, St. John's Cancer Centre, Lublin, Poland.
6
Roswell Park Cancer Institute, Buffalo, NY, USA.
7
Institut Català d'Oncologia (ICO) and Institut de Recerca contra la Leucèmia Josep Carreras (IJC), Hospital Germans Trias i Pujol, Badalona, Spain.
8
National Taiwan University, Medical College and Hospital, Taipei, Taiwan.
9
Ankara University Ibn Sina Hospital, Ankara, Turkey.
10
Wroclaw Medical University, Wroclaw, Poland.
11
Eli Lilly and Company, Indianapolis, IN, USA.
12
Eli Lilly and Company Limited, Windlesham, Surrey, UK.
13
Myeloma Unit, Division of Haematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.

Abstract

In this double-blind, Phase 2 study, 220 patients with relapsed/refractory multiple myeloma were randomly assigned 1:1:1 to receive placebo (N = 72), tabalumab 100 mg (N = 74), or tabalumab 300 mg (N = 74), each in combination with dexamethasone 20 mg and subcutaneous bortezomib 1·3 mg/m2 on a 21-day cycle. No significant intergroup differences were observed among primary (median progression-free survival [mPFS]) or secondary efficacy outcomes. The mPFS was 6·6, 7·5 and 7·6 months for the tabalumab 100, 300 mg and placebo groups, respectively (tabalumab 100 mg vs. placebo Hazard ratio (HR) [95% confidence interval (CI)] = 1·13 [0·80-1·59], P = 0·480; tabalumab 300 mg vs. placebo HR [95% CI] = 1·03 [0·72-1·45], P = 0·884). The most commonly-reported treatment-emergent adverse events were thrombocytopenia (37%), fatigue (37%), diarrhoea (35%) and constipation (32%). Across treatments, patients with low baseline BAFF (also termed TNFSF13B) expression (n = 162) had significantly longer mPFS than those with high BAFF expression (n = 55), using the 75th percentile cut-off point (mPFS [95% CI] = 8·3 [7·0-9·3] months vs. 5·8 [3·7-6·6] months; HR [95% CI] = 1·59 [1·11-2·29], P = 0·015). Although generally well tolerated, PFS was not improved during treatment with tabalumab compared to placebo. A higher dose of 300 mg tabalumab did not improve efficacy compared to the 100 mg dose. Nonetheless, BAFF appears to have some prognostic value in patients with multiple myeloma.

KEYWORDS:

B-cell activating factor (BAFF); bortezomib; multiple myeloma; tabalumab; treatment

PMID:
28005265
DOI:
10.1111/bjh.14483
[Indexed for MEDLINE]

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