Raje N.S.Moreau P.Terpos E.Benboubker L.Grząśko N.Holstein S.A.Oriol A.SHANG-YI HUANGBeksac M.Kuliczkowski K.Tai D.F.Wooldridge J.E.Conti I.Kaiser C.J.Nguyen T.S.Cronier D.M.Palumbo A.2021-01-122021-01-1220170007-1048https://www.scopus.com/inward/record.uri?eid=2-s2.0-85007137226&doi=10.1111%2fbjh.14483&partnerID=40&md5=94fc97826acf9a3b83f00dd0b45cf87ahttps://scholars.lib.ntu.edu.tw/handle/123456789/540454In 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.B-cell activating factor (BAFF); bortezomib; multiple myeloma; tabalumab; treatment[SDGs]SDG3bortezomib; dexamethasone; placebo; tabalumab; antineoplastic agent; bortezomib; dexamethasone; monoclonal antibody; tabalumab; adult; aged; anemia; area under the curve; Article; cancer combination chemotherapy; constipation; controlled study; coughing; diarrhea; dizziness; double blind procedure; drug efficacy; drug safety; drug tolerability; drug withdrawal; fatigue; febrile neutropenia; female; human; insomnia; kidney failure; major clinical study; male; maximum plasma concentration; multicenter study; multiple cycle treatment; multiple myeloma; nausea; overall survival; peripheral edema; peripheral neuropathy; phase 2 clinical trial; pneumonia; progression free survival; randomized controlled trial; sensory neuropathy; sepsis; septic shock; thrombocytopenia; time to maximum plasma concentration; upper respiratory tract infection; clinical trial; complication; disease free survival; middle aged; mortality; multiple myeloma; procedures; salvage therapy; treatment outcome; Adult; Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Dexamethasone; Disease-Free Survival; Double-Blind Method; Female; Humans; Male; Middle Aged; Multiple Myeloma; Salvage Therapy; Treatment Outcomejournal article10.1111/bjh.14483280052652-s2.0-85007137226