Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
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
A Phase Ib Multicenter, Open-Label Study To Determine The Recommended Dose And Regimen Of Durvalumab (Medi4736) Either As Monotherapy Or In Combination With Pomalidomide (POM) With Or Without Lowdose Dexamethasone (Dex) In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)
This is a multicenter, multicountry, open-label, Phase 1b study for dose finding as well as
parallel cohort dose expansion(s) to determine the recommended dose and regimen of
durvalumab either as monotherapy or in combination with pomalidomide (POM) with or without
low dose dex in subjects with Relapsed and Refractory Multiple Myeloma (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.
Are you eligible?
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)
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)
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
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
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,
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