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Phase 2 study of all‐oral ixazomib, cyclophosphamide and low‐dose dexamethasone for relapsed/refractory multiple myeloma
Author(s) -
Kumar Shaji K.,
Grzasko Norbert,
Delimpasi Sosana,
Jedrzejczak Wieslaw W.,
Grosicki Sebastian,
Kyrtsonis MarieChristine,
Spencer Andrew,
Gupta Neeraj,
Teng Zhaoyang,
Byrne Catriona,
Labotka Richard,
Dimopoulos Meletios A.
Publication year - 2019
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.15679
Subject(s) - dexamethasone , ixazomib , multiple myeloma , medicine , cyclophosphamide , oncology , refractory (planetary science) , lenalidomide , chemotherapy , carfilzomib , biology , astrobiology
Summary There is a need for efficacious, convenient treatments with long‐term tolerability for patients with relapsed/refractory multiple myeloma ( RRMM ). This phase 2 study evaluated the all‐oral combination of ixazomib, cyclophosphamide and dexamethasone (ICd). Patients with RRMM received ixazomib 4 mg and cyclophosphamide 300 mg/m 2 on days 1, 8 and 15, and dexamethasone 40 mg on days 1, 8, 15 and 22 in 28‐day cycles. The primary endpoint was overall response rate ( ORR ). Seventy‐eight patients were enrolled (median age 63·5 years). At data cut‐off, patients had received a median of 12 treatment cycles; 31% remained on treatment. ORR was 48% [16% very good partial response or better (≥ VGPR )]. ORR was 64% and 32% in patients aged ≥65 and <65 years (25% and 16% ≥VGPR), respectively. At a median follow‐up of 15·2 months, median progression‐free survival ( PFS ) was 14·2 months, with a trend towards better PFS in patients aged ≥65 years vs. <65 years (median 18·7 months vs. 12·0 months; hazard ratio 0·62, P = 0·14). ICd was well tolerated. The most common treatment‐emergent adverse events were diarrhoea (33%), nausea (24%), upper respiratory tract infection (24%), and thrombocytopenia (22%); 10 patients (13%) had peripheral neuropathy (one grade 3). This study is registered at ClinicalTrials.gov (NCT02046070).