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Phase 2 trial of ixazomib in patients with relapsed multiple myeloma not refractory to bortezomib.
- Source :
-
Blood cancer journal [Blood Cancer J] 2015 Aug 14; Vol. 5, pp. e338. Date of Electronic Publication: 2015 Aug 14. - Publication Year :
- 2015
-
Abstract
- This phase 2 trial was designed to evaluate ixazomib, an orally bioavailable proteasome inhibitor, in patients with myeloma who have limited prior exposure to bortezomib. Thirty-three patients with relapsed multiple myeloma were enrolled. Ixazomib was given at 5.5 mg weekly for 3 of 4 weeks. Dexamethasone was added for lack of a minor response (MR) by end of cycle 2 or lack of a partial response (PR) by end of cycle 4 or for disease progression at any time. Median age was 69 years; patients had a median of two prior therapies (range 1-7). A grade 3 or 4 adverse event considered at least possibly related to drug was seen in 19 (59%) and 6 (19%) patients, respectively. The most common adverse events were thrombocytopenia, fatigue, nausea and diarrhea. Dexamethasone was initiated in 22 (67%) patients, 17 for not reaching the desired response and 5 for progression. Response (⩾PR) to single agent was seen in five patients within four cycles of therapy including three patients with PR, one patient with complete response (CR) and one patient with stringent CR. Six additional patients with either an MR (2) or SD (4) achieved a PR after addition of dexamethasone, translating to an overall response rate of 34%.
- Subjects :
- Aged
Aged, 80 and over
Boron Compounds adverse effects
Dexamethasone administration & dosage
Disease-Free Survival
Female
Glycine administration & dosage
Glycine adverse effects
Humans
Male
Middle Aged
Multiple Myeloma mortality
Recurrence
Treatment Outcome
Antineoplastic Agents therapeutic use
Boron Compounds administration & dosage
Glycine analogs & derivatives
Multiple Myeloma drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 2044-5385
- Volume :
- 5
- Database :
- MEDLINE
- Journal :
- Blood cancer journal
- Publication Type :
- Academic Journal
- Accession number :
- 26275080
- Full Text :
- https://doi.org/10.1038/bcj.2015.60