Phase 2 study of all-oral ixazomib, cyclophosphamide and low-dose dexamethasone for relapsed/refractory multiple myeloma

Shaji K Kumar, Norbert Grzasko, Sosana Delimpasi, Wieslaw W. Jedrzejczak, Sebastian Grosicki, Marie Christine Kyrtsonis, Andrew Spencer, Neeraj Gupta, Zhaoyang Teng, Catriona Byrne, Richard Labotka, Meletios A. Dimopoulos

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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/m2 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).

Original languageEnglish (US)
JournalBritish Journal of Haematology
DOIs
StateAccepted/In press - Jan 1 2018

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Multiple Myeloma
Cyclophosphamide
Dexamethasone
Disease-Free Survival
Peripheral Nervous System Diseases
Therapeutics
ixazomib
Respiratory Tract Infections
Thrombocytopenia
Nausea
Diarrhea

Keywords

  • ixazomib
  • proteasome inhibitor
  • relapsed myeloma
  • response
  • survival

ASJC Scopus subject areas

  • Hematology

Cite this

Phase 2 study of all-oral ixazomib, cyclophosphamide and low-dose dexamethasone for relapsed/refractory multiple myeloma. / Kumar, Shaji K; Grzasko, Norbert; Delimpasi, Sosana; Jedrzejczak, Wieslaw W.; Grosicki, Sebastian; Kyrtsonis, Marie Christine; Spencer, Andrew; Gupta, Neeraj; Teng, Zhaoyang; Byrne, Catriona; Labotka, Richard; Dimopoulos, Meletios A.

In: British Journal of Haematology, 01.01.2018.

Research output: Contribution to journalArticle

Kumar, SK, Grzasko, N, Delimpasi, S, Jedrzejczak, WW, Grosicki, S, Kyrtsonis, MC, Spencer, A, Gupta, N, Teng, Z, Byrne, C, Labotka, R & Dimopoulos, MA 2018, 'Phase 2 study of all-oral ixazomib, cyclophosphamide and low-dose dexamethasone for relapsed/refractory multiple myeloma', British Journal of Haematology. https://doi.org/10.1111/bjh.15679
Kumar, Shaji K ; Grzasko, Norbert ; Delimpasi, Sosana ; Jedrzejczak, Wieslaw W. ; Grosicki, Sebastian ; Kyrtsonis, Marie Christine ; Spencer, Andrew ; Gupta, Neeraj ; Teng, Zhaoyang ; Byrne, Catriona ; Labotka, Richard ; Dimopoulos, Meletios A. / Phase 2 study of all-oral ixazomib, cyclophosphamide and low-dose dexamethasone for relapsed/refractory multiple myeloma. In: British Journal of Haematology. 2018.
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AU - Jedrzejczak, Wieslaw W.

AU - Grosicki, Sebastian

AU - Kyrtsonis, Marie Christine

AU - Spencer, Andrew

AU - Gupta, Neeraj

AU - Teng, Zhaoyang

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AU - Labotka, Richard

AU - Dimopoulos, Meletios A.

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