Publication Date:
2018-11-29
Description:
Introduction: Although a previous study with small numbers of patients (Pts) reported comparable efficacy and less toxicity of once-weekly CBD as an induction compared to twice-weekly CBD for newly diagnosed MM (NDMM) Pts (Blood 2010; 115:3416-3417), it has never been verified thereafter. Methods: This multicenter, single-arm, open-label, phase 2 study was conducted at 13 institutions in Japan. Pts aged 15-65 years with NDMM were eligible. Additional inclusion criteria were ECOG PS 0-2 and adequate organ functions. Pts with ≥G2 peripheral neuropathy (PN) were excluded. Pts were enrolled between January 2013 and November 2015. Induction chemotherapy consisted of four 28-day cycles of cyclophosphamide (CPA: 300 mg/m2, PO), bortezomib (1.3 mg/m2, SC), and dexamethasone (40 mg/body, PO) each administered on day 1, 8, 15, and 22. Stem cells were mobilized by administering CPA plus G-CSF. High-dose therapy (HDT) prior to ASCT was performed using melphalan (200 mg/m2). The primary endpoint was the post-induction ≥nCR rate. Observation was stopped on August 31, 2016. Results: A total of 38 Pts with median age of 61 (47-65 years old) were enrolled. ISS stages were I, II, and III in 10, 18, and 10 patients, respectively. Among the 34 chromosomal data-available Pts, del 13 and hypoploidy were observed in 2 and 1, respectively. During the induction, only one patient developed G4 hematological AE. G3 infectious AE was observed in 4 Pts (10.5%). Three Pts (7.9%) developed G4 non-hematological AE. PN was observed in 2 Pts (all
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
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