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
NCT ID: NCT02616640
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
114 participants
INTERVENTIONAL
2016-01-11
2024-07-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Durvalumab monotherapy
Intravenous (IV) durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle
Durvalumab
Durvalumab + pomalidomide (POM)
IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle and Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle
Durvalumab
Pomalidomide
Durvalumab + pomalidomide (POM) + dexamethasone (dex)
IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle with Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle and Oral dex 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of a 28-day cycle
Durvalumab
Pomalidomide
Dexamethasone
Interventions
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Durvalumab
Pomalidomide
Dexamethasone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Sternas, MD, PhD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Local Institution - 102
Baltimore, Maryland, United States
Local Institution - 114
Boston, Massachusetts, United States
Local Institution - 108
Boston, Massachusetts, United States
Local Institution - 115
Boston, Massachusetts, United States
Local Institution - 105
New York, New York, United States
Local Institution - 106
Charlotte, North Carolina, United States
Local Institution - 110
Cleveland, Ohio, United States
Local Institution - 107
Milwaukee, Wisconsin, United States
Local Institution - 201
Calgary, Alberta, Canada
Local Institution - 601
Lille, , France
Local Institution - 602
Poitiers, , France
Local Institution - 603
Toulouse, , France
Local Institution - 301
Tübingen, , Germany
Local Institution - 403
Pavia, , Italy
Local Institution - 405
Rozzano (MI), , Italy
Local Institution - 401
Torino, , Italy
Local Institution - 702
Amsterdam, , Netherlands
Local Institution - 701
Rotterdam, , Netherlands
Local Institution - 501
Barcelona, , Spain
Local Institution - 504
Madrid, , Spain
Local Institution - 502
Pamplona, , Spain
Local Institution - 505
Valencia, , Spain
Countries
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References
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Young MH, Pietz G, Whalen E, Copeland W, Thompson E, Fox BA, Newhall KJ. Immunomodulation by durvalumab and pomalidomide in patients with relapsed/refractory multiple myeloma. Sci Rep. 2021 Aug 12;11(1):16460. doi: 10.1038/s41598-021-95902-x.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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MEDI4736-MM-001
Identifier Type: -
Identifier Source: org_study_id
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