Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial

Lancet
Sagar LonialPeter M Voorhees

Abstract

New treatment options are needed for patients with multiple myeloma that is refractory to proteasome inhibitors and immunomodulatory drugs. We assessed daratumumab, a novel CD38-targeted monoclonal antibody, in patients with refractory multiple myeloma. In this open-label, multicentre, phase 2 trial done in Canada, Spain, and the USA, patients (age ≥18 years) with multiple myeloma who were previously treated with at least three lines of therapy (including proteasome inhibitors and immunomodulatory drugs), or were refractory to both proteasome inhibitors and immunomodulatory drugs, were randomly allocated in a 1:1 ratio to receive intravenous daratumumab 8 mg/kg or 16 mg/kg in part 1 stage 1 of the study, to decide the dose for further assessment in part 2. Patients received 8 mg/kg every 4 weeks, or 16 mg/kg per week for 8 weeks (cycles 1 and 2), then every 2 weeks for 16 weeks (cycles 3-6), and then every 4 weeks thereafter (cycle 7 and higher). The allocation schedule was computer-generated and randomisation, with permuted blocks, was done centrally with an interactive web response system. In part 1 stage 2 and part 2, patients received 16 mg/kg dosed as in part 1 stage 1. The primary endpoint was overall response rate (parti...Continue Reading

References

Oct 15, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jean-Luc HarousseauPhilippe Moreau
Dec 30, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Ingemar TuressonOla Landgren
Feb 5, 2011·Blood·S Vincent RajkumarUNKNOWN International Myeloma Workshop Consensus Panel 1
Aug 27, 2013·Leukemia·W J ChngUNKNOWN International Myeloma Working Group
Sep 24, 2013·Expert Review of Anticancer Therapy·Junya KurodaMasafumi Taniwaki
Nov 20, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Prashant KapoorMorie A Gertz
Mar 13, 2015·Transfusion·Claudia I ChapuyRichard M Kaufman
Apr 2, 2015·PET Clinics·Patrick J Peller
Apr 17, 2015·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Jacob P Laubach, Paul G Richardson
Jun 3, 2015·The New England Journal of Medicine·Sagar LonialUNKNOWN ELOQUENT-2 Investigators
Aug 27, 2015·The New England Journal of Medicine·Henk M LokhorstPaul G Richardson

❮ Previous
Next ❯

Citations

Feb 24, 2016·Current Hematologic Malignancy Reports·Hans C LeeJatin J Shah
Jan 19, 2016·Lancet·S Vincent Rajkumar
Jun 14, 2016·American Journal of Hematology·S Vincent Rajkumar
Jul 16, 2016·Clinical Journal of the American Society of Nephrology : CJASN·Jonathan J Hogan, Brendan M Weiss
Jul 5, 2016·Expert Review of Clinical Immunology·Jean-Samuel BoudreaultPhilippe Moreau
Jul 23, 2016·Blood·Yu-Tzu Tai, Kenneth C Anderson
Jul 19, 2016·Expert Review of Hematology·Despoina FotiouEfstathios Kastritis
Aug 1, 2016·Clinical Biochemistry·Aaron Seth RosenbergIshwarlal Jialal
Aug 12, 2016·Future Oncology·Wilson I GonsalvesFrancis K Buadi
Aug 18, 2016·Expert Opinion on Biological Therapy·Sagar LonialPaul Richardson
Nov 3, 2016·Nature Reviews. Clinical Oncology·Salomon ManierIrene M Ghobrial
Aug 25, 2016·The New England Journal of Medicine·Antonio PalumboUNKNOWN CASTOR Investigators
Sep 8, 2016·Transfusion·Claudia I ChapuyUNKNOWN DARA-DTT Study Group* for the BEST Collaborative
Sep 4, 2016·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Leo RascheStefan Knop
Aug 28, 2016·Journal of Geriatric Oncology·Nicolas Kint, Michel Delforge
Nov 9, 2016·Best Practice & Research. Clinical Haematology·Jorge J CastilloSteven P Treon
Oct 19, 2016·Case Reports in Oncological Medicine·Muhammad HusnainAmit Agarwal
Oct 6, 2016·The New England Journal of Medicine·Meletios A DimopoulosUNKNOWN POLLUX Investigators
Oct 18, 2016·Current Opinion in Hematology·Karen M K De VooghtWouter W van Solinge
Oct 14, 2016·Leukemia & Lymphoma·Eli MuchtarMorie A Gertz
Oct 22, 2016·Blood Cancer Journal·B LipeJ Mikhael
Oct 21, 2016·Expert Opinion on Pharmacotherapy·Maria GavriatopoulouMeletios A Dimopoulos
Nov 3, 2016·Clinical Pharmacology and Therapeutics·J P LaubachD L Longo
Nov 20, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·P MustoUNKNOWN International Myeloma Working Group
Jan 25, 2017·Expert Review of Hematology·Annamaria BrioliMarie Von Lilienfeld-Toal
Jan 24, 2017·Expert Review of Hematology·Jean-Samuel BoudreaultPhilippe Moreau
Jan 6, 2017·Archives of Pathology & Laboratory Medicine·Shiyong LiKaren P Mann
Feb 18, 2017·Leukemia·C TouzeauC Dumontet
Mar 25, 2017·Blood Cancer Journal·S SengsayadethM Mohty
Apr 6, 2017·The New England Journal of Medicine·Michel AttalUNKNOWN IFM 2009 Study
Apr 8, 2017·British Journal of Haematology·Ashraf BadrosParameswaran Hari
Apr 22, 2017·Cancer Treatment Reviews·Leo RascheFaith E Davies
Apr 8, 2017·Expert Review of Hematology·María J Cejalvo, Javier de la Rubia
Apr 25, 2017·Expert Opinion on Biological Therapy·Cyrille Touzeau, Philippe Moreau
May 16, 2017·Expert Review of Hematology·Sonja Genadieva StavricAlessandra Larocca
Apr 28, 2017·Expert Opinion on Investigational Drugs·Mattia D'AgostinoFrancesca Gay

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