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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.
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.

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT02616640

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There is 1 Location for this study

See Locations Near You

University of Arkansas
Little Rock Arkansas, 72205, United States
Johns Hopkins Oncology Center
Baltimore Maryland, 21231, United States
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston Massachusetts, 02114, United States
Dana-Farber Partners Cancer Care, Inc.
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Mt. Sinai School of Medicine
New York New York, 10029, United States
Weill Medical College of Cornell University
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State Medical Center
Columbus Ohio, 43210, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Tom Baker Cancer Center
Calgary Alberta, T2N 4, Canada
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille , 59037, France
CHU Nantes Hotel Dieu
Nantes , 44093, France
CHU Bordeaux
Pessac , 33604, France
CHU La Miletrie
Poitiers Cedex , 86021, France
Institut universitaire du cancer de Toulouse (IUCT) - Oncopole
Toulouse CEDEX 9 , 31059, France
Universitaetsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Universitaetsklinikum EssenZentrum fuer Innere Medizin
Essen , 45122, Germany
University of Heidelberg
Heidelberg , D-691, Germany
Universitaetsklinikum Jena
Jena , 07740, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
Istituto Nazionale Dei Tumori
Milano , 20133, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"
Napoli , 80131, Italy
Policlinico San Matteo Universita Di Pavia
Pavia 2 , 27100, Italy
Istituto Clinico Humanitas
Rozzano (MI) , 20089, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
VU University Medical Center VU Medisch Centrum
Amsterdam , 1081 , Netherlands
Erasmus Medical Center
Rotterdam , 3015 , Netherlands
ICO-Hospital Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT02616640

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

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