title: Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma.
abstract: Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUS study assessed safety and efficacy of pomalidomide plus low-dose dexamethasone in the largest cohort to date of patients with RRMM. Patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy were eligible. Pomalidomide 4 mg was given on days 1-21 of 28-day cycles with low-dose dexamethasone 40 mg (20 mg for patients aged >75 years) on days 1, 8, 15, and 22 until progressive disease or unacceptable toxicity. Safety was the primary end point; secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Among 682 patients enrolled, median age was 66 years, and median time since diagnosis was 5.3 years. Median number of prior regimens was 5. Most patients were refractory to both lenalidomide and bortezomib (80.2%). Median follow-up was 16.8 months; median duration of treatment was 4.9 months. Most frequent grade 3/4 treatment-emergent adverse events were hematologic (neutropenia [49.7%], anemia [33.0%], and thrombocytopenia [24.1%]). Most common grade 3/4 nonhematologic toxicities were pneumonia (10.9%) and fatigue (5.9%). Grade 3/4 venous thromboembolism and peripheral neuropathy were rare (1.6% each). The ORR was 32.6%, and the median DOR was 7.4 months. Median PFS and OS were 4.6 months and 11.9 months, respectively. We present the largest trial to date evaluating pomalidomide plus low-dose dexamethasone in patients with RRMM, further confirming that this regimen offers clinically meaningful benefit and is generally well tolerated. www.Clinicaltrials.gov identifier NCT01712789.
authors.affiliation: National and Kapodistrian University of Athens, Athens, Greece.
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
authors.affiliation: University of Turin, Turin, Italy;
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
authors.affiliation: University of Milan, Fondazione IRCCS Istituto Nazionale de Tumori, Milan, Italy;
authors.forename: Paolo
authors.initials: P
authors.lastname: Corradini
authors.affiliation: Bologna University School of Medicine, Bologna, Italy;
authors.forename: Michele
authors.initials: M
authors.lastname: Cavo
authors.affiliation: University Hospital Leuven, Leuven, Belgium;
authors.forename: Michel
authors.initials: M
authors.lastname: Delforge
authors.affiliation: University of Catania, Catania, Italy;
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.affiliation: University Hospital of Tuebingen, Tuebingen, Germany;
authors.forename: Katja C
authors.initials: KC
authors.lastname: Weisel
authors.affiliation: Institut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain;
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.affiliation: Skane University Hospital, Lund University, Lund, Sweden;
authors.forename: Markus
authors.initials: M
authors.lastname: Hansson
authors.affiliation: University of Bari Medical School, Bari, Italy;
authors.forename: Angelo
authors.initials: A
authors.lastname: Vacca
authors.affiliation: Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Blanchard
authors.affiliation: University Hospital Heidelberg and German Cancer Research Center, Heidelberg, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Goldschmidt
authors.affiliation: Université Catholique de Louvain, Centre Hospitalier Universitaire, Université Catholique de Louvain Namur, Yvoir, Belgium;
authors.forename: Chantal
authors.initials: C
authors.lastname: Doyen
authors.affiliation: The Royal Marsden Hospital, Surrey, United Kingdom;
authors.forename: Martin
authors.initials: M
authors.lastname: Kaiser
authors.affiliation: Santa Chiara Hospital, University of Pisa, Pisa, Italy;
authors.forename: Mario
authors.initials: M
authors.lastname: Petrini
authors.affiliation: Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland;
authors.forename: Pekka
authors.initials: P
authors.lastname: Anttila
authors.affiliation: Hospedale Niguarda Ca' Granda, Milan, Italy;
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Cafro
authors.affiliation: University Medical Center Utrecht, Utrecht, The Netherlands;
authors.forename: Reinier
authors.initials: R
authors.lastname: Raymakers
authors.affiliation: Clinica Universidad de Navarra, Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain;
authors.forename: Jesus
authors.initials: J
authors.lastname: San-Miguel
authors.affiliation: Hospital General Universitario Morales Meseguer, Murcia, Spain;
authors.forename: Felipe
authors.initials: F
authors.lastname: de Arriba
authors.affiliation: Wurzburg University Medical Center, Wurzburg, Germany;
authors.forename: Stefan
authors.initials: S
authors.lastname: Knop
authors.affiliation: Universitatsklinikum, Medizinsche Klinik und Poliklinik I, Dresden, Germany;
authors.forename: Christoph
authors.initials: C
authors.lastname: Röllig
authors.affiliation: Complejo Asistencial Universitario de Salamanca Centro Investigación del Cáncer-Instituto de Biología Molecular y Celular del Cancer) Cancer Research Center, Salamanca, Spain;
authors.forename: Enrique M
authors.initials: EM
authors.lastname: Ocio
authors.affiliation: Myeloma Institute for Research and Therapy, University of Arkansas Medical School, Little Rock, AR;
authors.forename: Gareth
authors.initials: G
authors.lastname: Morgan
authors.affiliation: Celgene International Sàrl, Boudry, Switzerland;
authors.forename: Neil
authors.initials: N
authors.lastname: Miller
authors.affiliation: Celgene International Sàrl, Boudry, Switzerland;
authors.forename: Mathew
authors.initials: M
authors.lastname: Simcock
authors.affiliation: Celgene International Sàrl, Boudry, Switzerland;
authors.forename: Teresa
authors.initials: T
authors.lastname: Peluso
authors.affiliation: Celgene Corporation, Summit, NJ; and.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Herring
authors.affiliation: Celgene Corporation, Summit, NJ; and.
authors.forename: Lars
authors.initials: L
authors.lastname: Sternas
authors.affiliation: Celgene Corporation, Summit, NJ; and.
authors.forename: Mohamed H
authors.initials: MH
authors.lastname: Zaki
authors.affiliation: University Hospital Hotel-Dieu, Nantes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; C467566:pomalidomide