Clinical Trials

The 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

Protocol: OSU-15196

Full Title

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)

Purpose

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?

Inclusion Criteria:

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.

Exclusion Criteria:

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

Multiple Myeloma