Multiple Myeloma Clinical Trial
A Study to Determine Dose and Regimen of Durvalumab as Monotherapy or in Combination With Pomalidomide With or Without Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen.
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.
Has a confirmed diagnosis of active multiple myeloma and measurable disease.
Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy
Must have failed last line of treatment (refractory to last line of treatment).
Must have achieved at least a stable disease (SD) for at least 1 cycle of treatment to at least 1 prior anti-myeloma regimen before developing Progressive disease (PD) (relapsed)
Prior anti-myeloma treatments must have included a lenalidomide AND proteasome inhibitor alone or in combination.
Has performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
The extramedullary plasmacytoma (EMP) sub-group, must have radiologically measurable EMP disease (soft tissue or bone related) that is amenable to biopsy and does not need to have measurable disease.
Has non-secretory or oligosecretory multiple myeloma
Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
Has undergone prior organ or allogeneic hematopoetic stem cell transplantation
Has received previous therapy with pomalidomide and did not achieve at least a stable disease
Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), antiprogrammed death-ligand 2 (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 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
Had rash ≥ Grade 3 during prior thalidomide, lenalidomide, or pomalidomide therapy
Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, POM, or dex
Has peripheral neuropathy ≥ Grade 2
Has a known additional malignancy that is progressing or requires active treatment (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).
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
Is a current smoker
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There is 1 Location for this study
Little Rock Arkansas, 72205, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Hackensack New Jersey, 07601, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Milwaukee Wisconsin, 53226, United States
Calgary Alberta, T2N 4, Canada
Lille , 59037, France
Nantes , 44093, France
Pessac , 33604, France
Poitiers Cedex , 86021, France
Toulouse CEDEX 9 , 31059, France
Dresden , 01307, Germany
Essen , 45122, Germany
Heidelberg , D-691, Germany
Jena , 07740, Germany
Tuebingen , 72076, Germany
Milano , 20133, Italy
Napoli , 80131, Italy
Pavia 2 , 27100, Italy
Rozzano (MI) , 20089, Italy
Torino , 10126, Italy
Amsterdam , 1081 , Netherlands
Rotterdam , 3015 , Netherlands
Barcelona , 08916, Spain
Madrid , 28041, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Valencia , 46026, Spain
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