title: An international, multicenter, prospective, observational study of neutropenia in patients being treated with lenalidomide + dexamethasone for relapsed or relapsed/refractory multiple myeloma (RR-MM).
abstract: 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. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Haematology, Hôpital Claude Huriez, Lille, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Leleu
authors.affiliation: Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
authors.forename: Evangelos
authors.initials: E
authors.lastname: Terpos
authors.affiliation: Department of Hematology, Hospital Universitario De Salamanca, Salamanca, Spain.
authors.forename: Ramón García
authors.initials: RG
authors.lastname: Sanz
authors.affiliation: Department of Hematology, Royal Perth Hospital and University of Western Australia, Crawley, Western Australia, Australia.
authors.forename: Julian
authors.initials: J
authors.lastname: Cooney
authors.affiliation: Mater University Hospital, UCD School of Medicine and Medical Science, Dublin, Ireland.
authors.forename: Peter
authors.initials: P
authors.lastname: O'Gorman
authors.affiliation: Department of Hemato-Oncology, Medical Faculty of Palacky University and University Hospital Olomouc, Olomouc, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Minarik
authors.affiliation: IIIrd Medical Department, Paracelsus Medical University Salzburg and Salzburg Cancer Research Institute, Salzburg, Austria.
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
authors.affiliation: Center for Clinical Hematology, Nottingham University Hospitals, Nottingham, United Kingdom.
authors.forename: Catherine
authors.initials: C
authors.lastname: Williams
authors.affiliation: Consultant Biostatistician, Cambridge, United Kingdom.
authors.forename: Diep
authors.initials: D
authors.lastname: Gray
authors.affiliation: Research and Development, Amgen (Europe) GmbH, Zug, Switzerland.
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Szabo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D038622:Internationality; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications* / Q000188:drug therapy; D015999:Multivariate Analysis; D009503:Neutropenia / Q000139:chemically induced*; D011446:Prospective Studies; D016879:Salvage Therapy; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide