Multiple Myeloma Clinical Trial
A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
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.
Must have measurable disease as defined by m-protein or serum free light chain.
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
Has non-secretory multiple myeloma
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
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There are 43 Locations for this study
Duarte California, 91010, United States
Los Angeles California, 90095, United States
Denver Colorado, 80218, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Bethesda Maryland, 20817, United States
Boston Massachusetts, 02115, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Seattle Washington, 98104, United States
Brugge , 8000, Belgium
Leuven , B-300, Belgium
Yvoir , 5530, Belgium
Saint John New Brunswick, E2L 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H4A 3, Canada
Copenhagen , 2100, Denmark
Odense , DK-50, Denmark
Vejle , 7100, Denmark
Dresden , 01307, Germany
Heidelberg , 69115, Germany
Tubingen , 72076, Germany
Wuerzburg , 97080, Germany
Bologna , 40138, Italy
Novara , 28100, Italy
Padova , 35128, Italy
Palermo , 90146, Italy
Pisa , 56126, Italy
Barcelona , 08907, Spain
Barcelona , 08907, Spain
Gijon , 33394, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Gothenburg , 60 Go, Sweden
Lund , 221 8, Sweden
Stockholm , SE-14, Sweden
London , EC1A , United Kingdom
Manchester , M20 4, United Kingdom
Oxford , 0X3 7, United Kingdom
Sutton (Surrey) , SM2 5, United Kingdom
Wolverhampton , WV10 , United Kingdom
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