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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

37

Study ID:

NCT02807454

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 43 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
UCLA Division of Hematology Oncology
Los Angeles California, 90095, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Center For Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Dana-Farber Partners Cancer Care, Inc.
Boston Massachusetts, 02115, United States
Washington University
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Perelman Center for Advanced Medicine
Philadelphia Pennsylvania, 19104, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Swedish Medical Center
Seattle Washington, 98104, United States
AZ St-Jan Brugge Oostende AV
Brugge , 8000, Belgium
Universitaire Ziekenhuizen Leuven Univeristy Hospitals Leuven
Leuven , B-300, Belgium
Cliniques Universitaires UCL de Mont-Godine
Yvoir , 5530, Belgium
Saint John Regional Hospital
Saint John New Brunswick, E2L 3, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Hopital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
MUHC Glen Site
Montreal Quebec, H4A 3, Canada
Rigshospitalet University Hospital
Copenhagen , 2100, Denmark
Odense University Hospital
Odense , DK-50, Denmark
Vejle Hospital
Vejle , 7100, Denmark
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden , 01307, Germany
Universitatsklinikum Heidelberg
Heidelberg , 69115, Germany
University Hospital Tubingen
Tubingen , 72076, Germany
Universitatsklinikum Wuerzburg
Wuerzburg , 97080, Germany
Policlinico S. Orsola - Malpighi
Bologna , 40138, Italy
A.O.U. Maggiore della Carità
Novara , 28100, Italy
Azienda Ospedaliera di Padova
Padova , 35128, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo , 90146, Italy
A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
Pisa , 56126, Italy
Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
Barcelona , 08907, Spain
Local Institution - 453
Barcelona , 08907, Spain
Hospital de Cabuenes
Gijon , 33394, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Sahlgrenska University Hospital
Gothenburg , 60 Go, Sweden
Skanes Universitetssjukhus Malmo
Lund , 221 8, Sweden
Karolinska Universitetssjukhuset - Huddinge
Stockholm , SE-14, Sweden
St. Bartholomew's and The Royal London Hospital
London , EC1A , United Kingdom
Christie Hospital
Manchester , M20 4, United Kingdom
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine
Oxford , 0X3 7, United Kingdom
Royal Marsden Hospital
Sutton (Surrey) , SM2 5, United Kingdom
The Royal Wolverhampton Hospital NHS Trust
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

37

Study ID:

NCT02807454

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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