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Phase 1/2 study of cyclin-dependent kinase (CDK)4/6 inhibitor palbociclib (PD-0332991) with bortezomib and dexamethasone in relapsed/refractory multiple myeloma
R. Niesvizky, AZ. Badros, LJ. Costa, SA. Ely, SB. Singhal, EA. Stadtmauer, NA. Haideri, A. Yacoub, G. Hess, S. Lentzsch, I. Spicka, AA. Chanan-Khan, MS. Raab, S. Tarantolo, R. Vij, JA. Zonder, X. Huang, D. Jayabalan, M. Di Liberto, X. Huang, Y....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, fáze I, klinické zkoušky, fáze II, časopisecké články, multicentrická studie, práce podpořená grantem
- MeSH
- bortezomib MeSH
- chemorezistence MeSH
- cyklin-dependentní kinasa 4 antagonisté a inhibitory MeSH
- cyklin-dependentní kinasa 6 antagonisté a inhibitory MeSH
- dexamethason aplikace a dávkování MeSH
- dospělí MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom farmakoterapie metabolismus mortalita patologie MeSH
- monitorování léčiv MeSH
- opakovaná terapie MeSH
- piperaziny aplikace a dávkování MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- pyridiny aplikace a dávkování MeSH
- recidiva MeSH
- rozvrh dávkování léků MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- staging nádorů MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze I MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
This phase 1/2 study was the first to evaluate the safety and efficacy of the cyclin-dependent kinase (CDK) 4/6-specific inhibitor palbociclib (PD-0332991) in sequential combination with bortezomib and dexamethasone in relapsed/refractory multiple myeloma. The recommended phase 2 dose was palbociclib 100 mg orally once daily on days 1-12 of a 21-day cycle with bortezomib 1.0 mg/m2 (intravenous) and dexamethasone 20 mg (orally 30 min pre-bortezomib dosing) on days 8 and 11 (early G1 arrest) and days 15 and 18 (cell cycle resumed). Dose-limiting toxicities were primarily cytopenias; most other treatment-related adverse events were grade≤3. At a bortezomib dose lower than that in other combination therapy studies, antitumor activity was observed (phase 1). In phase 2, objective responses were achieved in 5 (20%) patients; 11 (44%) achieved stable disease. Biomarker and pharmacodynamic assessments demonstrated that palbociclib inhibited CDK4/6 and the cell cycle initially in most patients.
b Department of Medicine University of Maryland Greenebaum Cancer Center Baltimore MD USA
e Division of Hematology Oncology Northwestern University Feinberg School of Medicine Chicago IL USA
g Oncology Hematology and Internal Medicine Saint Luke's Health System Kansas City MO USA
h Hematology and Oncology University of Kansas Medical Center Kansas City KS USA
j Division of Hematology Oncology Columbia University Medical Center New York NY USA
k 1st Department of Internal Medicine Charles University Praha Czech Republic
l Department of Hematology Oncology Mayo Clinic Jacksonville FL USA
Medicine and Hematology Oncology Weill Cornell Medical College New York NY USA
Methodist Hospital and Nebraska Cancer Specialists Omaha NE USA
o Section of BMT and Leukemia Washington University School of Medicine St Louis MO USA
p Oncology and Internal Medicine Karmanos Cancer Institute Wayne State University Detroit MI USA
Pathology and Laboratory Medicine Weill Cornell Medical College New York NY USA
Citace poskytuje Crossref.org
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