Spots Global Cancer Trial Database for A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
Official Title: A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
Study ID: NCT02807454
Conditions
Study Description
Brief Summary: This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3). On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
UCLA Division of Hematology Oncology, Los Angeles, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Local Institution - 007, Denver, Colorado, United States
Emory University Hospital, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Center For Cancer and Blood Disorders, Bethesda, Maryland, United States
Dana-Farber Partners Cancer Care, Inc., Boston, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
University of Pennsylvania - Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Tennessee Oncology Nashville Drug Development Unit, Nashville, Tennessee, United States
Swedish Medical Center, Seattle, Washington, United States
AZ St-Jan Brugge Oostende AV, Brugge, , Belgium
Universitaire Ziekenhuizen Leuven Univeristy Hospitals Leuven, Leuven, , Belgium
Cliniques Universitaires UCL de Mont-Godine, Yvoir, , Belgium
Local Institution - 103, Saint John, New Brunswick, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Local Institution - 104, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Local Institution - 101, Montreal, Quebec, Canada
MUHC Glen Site, Montreal, Quebec, Canada
Local Institution - 552, Copenhagen, , Denmark
Rigshospitalet University Hospital, Copenhagen, , Denmark
Local Institution - 553, Odense, , Denmark
Odense University Hospital, Odense, , Denmark
Local Institution - 551, Vejle, , Denmark
Vejle Hospital, Vejle, , Denmark
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden, , Germany
Local Institution - 203, Heidelberg, , Germany
Universitatsklinikum Heidelberg, Heidelberg, , Germany
University Hospital Tubingen, Tubingen, , Germany
Local Institution - 201, Wuerzburg, , Germany
Universitatsklinikum Wuerzburg, Wuerzburg, , Germany
Local Institution - 354, Bologna, , Italy
Policlinico S. Orsola - Malpighi, Bologna, , Italy
A.O.U. Maggiore della Carità, Novara, , Italy
Local Institution - 353, Novara, , Italy
Azienda Ospedaliera di Padova, Padova, , Italy
Local Institution - 355, Padova, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Palermo, , Italy
A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia, Pisa, , Italy
Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO, Barcelona, , Spain
Local Institution - 453, Barcelona, , Spain
Hospital de Cabuenes, Gijon, , Spain
Local Institution - 451, Gijon, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Local Institution - 452, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Sahlgrenska University Hospital, Gothenburg, , Sweden
Local Institution - 501, Lund, , Sweden
Skanes Universitetssjukhus Malmo, Lund, , Sweden
Local Institution - 502, Stockholm, , Sweden
Karolinska Universitetssjukhuset - Huddinge, Stockholm, , Sweden
St. Bartholomew's and The Royal London Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Local Institution - 252, Oxford, , United Kingdom
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine, Oxford, , United Kingdom
Local Institution - 253, Sutton (Surrey), , United Kingdom
Royal Marsden Hospital, Sutton (Surrey), , United Kingdom
The Royal Wolverhampton Hospital NHS Trust, Wolverhampton, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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