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Am J Hematol. 2016 Aug;91(8):806-11. doi: 10.1002/ajh.24416. Epub 2016 Jun 8.

An international, multicenter, prospective, observational study of neutropenia in patients being treated with lenalidomide + dexamethasone for relapsed or relapsed/refractory multiple myeloma (RR-MM).

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Department of Haematology, Hôpital Claude Huriez, Lille, France.
Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
Department of Hematology, Hospital Universitario De Salamanca, Salamanca, Spain.
Department of Hematology, Royal Perth Hospital and University of Western Australia, Crawley, Western Australia, Australia.
Mater University Hospital, UCD School of Medicine and Medical Science, Dublin, Ireland.
Department of Hemato-Oncology, Medical Faculty of Palacky University and University Hospital Olomouc, Olomouc, Czech Republic.
IIIrd Medical Department, Paracelsus Medical University Salzburg and Salzburg Cancer Research Institute, Salzburg, Austria.
Center for Clinical Hematology, Nottingham University Hospitals, Nottingham, United Kingdom.
Consultant Biostatistician, Cambridge, United Kingdom.
Research and Development, Amgen (Europe) GmbH, Zug, Switzerland.


Neutropenia is a well-known dose-limiting toxicity associated with lenalidomide plus dexamethasone treatment in patients with multiple myeloma; however, little is known about its management and associated outcomes in the real world setting. The present prospective, multicenter, observational study evaluated the incidence, management, and outcomes of grade 3/4 neutropenia in patients with relapsed or relapsed/refractory multiple myeloma who initiated treatment with lenalidomide plus dexamethasone. Of 198 patients, 62 (31%, 95% CI: 25, 38) experienced grade 3/4 neutropenia, and half of these patients experienced 3 or more events during the 12-month observational period. Grade 3/4 neutropenia occurred throughout lenalidomide treatment, with a median time to first event of 8.8 weeks (Q1, Q3: 5.9, 17.3). In a multivariate analysis, diagnosis of relapsed and refractory disease was associated with grade 3/4 neutropenia. Lenalidomide exposure reduction, use of G-CSF, unplanned hospitalization, and outpatient clinic visits were more common in patients who experienced grade 3/4 neutropenia than in those who did not. In conclusion, grade 3/4 neutropenia is a common toxicity and patients are at continued risk throughout treatment with lenalidomide and dexamethasone. Further efforts should be made to improve the recommendations for neutropenia management in this population. Am. J. Hematol. 91:806-811, 2016.

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