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Dose‐escalation study of tabalumab with bortezomib and dexamethasone in Japanese patients with multiple myeloma
- Source :
- Cancer Science
- Publication Year :
- 2016
- Publisher :
- Wiley, 2016.
-
Abstract
- B-cell activating factor (BAFF) promotes the survival and adhesion of multiple myeloma (MM) cells. Tabalumab (LY2127399) is an anti-BAFF monoclonal antibody. This phase 1, multicenter, open-label, nonrandomized, dose-escalation study evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of tabalumab in combination with bortezomib and dexamethasone in Japanese patients with relapsed or refractory MM (RRMM). Sixteen patients received intravenous i.v. tabalumab 100 mg (Cohort 1, n = 4) or i.v. tabalumab 300 mg (Cohort 2, n = 12) in combination with oral dexamethasone 20 mg/day and i.v. or s.c. bortezomib 1.3 mg/m(2) . All patients had treatment-emergent adverse events (TEAE) possibly related to study treatment; the most common TEAE were thrombocytopenia (81.3%), lymphopenia (43.8%) and increased alanine aminotransferase (43.8%). Two (20.0%) dose-limiting toxicities were observed, both in Cohort 2 (tabalumab 300 mg), which was below the predefined cutoff for tolerability (
- Subjects :
- Male
0301 basic medicine
Cancer Research
LY2127399
tabalumab
Pharmacology
Gastroenterology
Dexamethasone
Bortezomib
0302 clinical medicine
Recurrence
Antineoplastic Combined Chemotherapy Protocols
Anti‐B‐cell activating factor monoclonal antibody
Multiple myeloma
Aged, 80 and over
education.field_of_study
Antibodies, Monoclonal
General Medicine
Middle Aged
Combined Modality Therapy
multiple myeloma
Tabalumab
Treatment Outcome
Oncology
Tolerability
030220 oncology & carcinogenesis
Disease Progression
Female
Original Article
Drug Monitoring
medicine.drug
medicine.medical_specialty
Population
Antibodies, Monoclonal, Humanized
03 medical and health sciences
Pharmacokinetics
Clinical Research
Internal medicine
medicine
Humans
education
Aged
business.industry
Original Articles
medicine.disease
phase 1 study
030104 developmental biology
Drug Resistance, Neoplasm
Pharmacodynamics
business
Subjects
Details
- ISSN :
- 13497006 and 13479032
- Volume :
- 107
- Database :
- OpenAIRE
- Journal :
- Cancer Science
- Accession number :
- edsair.doi.dedup.....f7a88b4bdfa482529888010d8bb1968f