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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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