A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
NCT ID: NCT02807454
Last Updated: 2023-02-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
37 participants
INTERVENTIONAL
2016-07-07
2022-01-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daratumumab Plus Durvalumab Treatment
* Intravenous (IV) durvalumab at 1500mg on Day 1 or 2 of a 28-day cycle
* IV daratumumab at 16mg/kg on days 1, 8, 15 and 22 at cycles 1-2; on days 1 and 15 at cycles 3-6; and on day 1 from cycle 7 onward
Daratumumab
Durvalumab
Pomalidomide+ Daratumumab+ Durvalumab+ Dexamethasone Treatment
* Intravenous (IV) durvalumab at 1500mg on Day 1 or 2 of a 28-day cycle
* IV daratumumab at 16mg/kg on days 1, 8, 15 and 22 at cycles 1-2; on days 1 and 15 at cycles 3-6; and on day 1 from cycle 7 onward
* oral POM at 4mg/day on days 1 to 21
* oral/IV dex at 40mg/day (\>75 years old) or 20mg/day (\>75 years old) on days 1, 8, 15 and 22
Daratumumab
Durvalumab
Pomalidomide
Dexamethasone
Interventions
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Daratumumab
Durvalumab
Pomalidomide
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
* Must have failed last line of treatment (refractory to last line of treatment).
* Must have achieved at least a minimal response (MR) to at least 1 prior anti-myeloma regimen before developing PD (relapsed)
* Has performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Must be at least 18 years of age
Exclusion Criteria
* Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
* Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
* Has received prior treatment with daratumumab or other anti-CD38 therapies previously
* Has undergone prior organ or allogeneic hematopoetic stem cell transplantation
* Has received autologous stem cell transplantation (ASCT) within 12 weeks before the date of randomization.
* Has received prior treatment with a monoclonal antibody within 5 half-lives of Study Day 1
* Has received investigational agents within 28 days or 5 half-lives (whichever is longer) of Study Day 1
* Has received live, attenuated vaccine within 30 days prior to Study Day 1
* Has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal
* Has moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification.
* Is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
* Has a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years (with the exception Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer \[T1a or T1b\] or prostate cancer that is curative)
* Has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma
* Has clinically significant cardiac disease
* Is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
St 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
Bruges, , 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
Tübingen, , Germany
Local Institution - 201
Würzburg, , Germany
Universitatsklinikum Wuerzburg
Würzburg, , 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
Padua, , Italy
Local Institution - 355
Padua, , 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
Gijón, , Spain
Local Institution - 451
Gijón, , 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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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MEDI4736-MM-003
Identifier Type: -
Identifier Source: org_study_id
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