A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
NCT ID: NCT03582033
Last Updated: 2024-12-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
83 participants
INTERVENTIONAL
2018-11-01
2023-11-09
Brief Summary
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The study will have several parts. In Parts A and B, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works.
In Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Parts A and B: SEA-BCMA Monotherapy
SEA-BCMA
SEA-BCMA
Given into the vein (IV; intravenously)
Part C: SEA-BCMA + Dexamethasone Combination Therapy
SEA-BCMA + dexamethasone
SEA-BCMA
Given into the vein (IV; intravenously)
dexamethasone
Given by mouth (orally) or by IV
Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy
SEA-BCMA + dexamethasone + pomalidomide
SEA-BCMA
Given into the vein (IV; intravenously)
dexamethasone
Given by mouth (orally) or by IV
pomalidomide
Given orally
Interventions
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SEA-BCMA
Given into the vein (IV; intravenously)
dexamethasone
Given by mouth (orally) or by IV
pomalidomide
Given orally
Eligibility Criteria
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Inclusion Criteria
* Must have MM that is relapsed or refractory
* Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
* Measurable disease, as defined by at least one of the following: (1) serum M protein 0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain (FLC) 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda FLC ratio.
* Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
* Life expectancy of greater than 3 months in the opinion of the investigator
* Adequate hematologic, renal, and hepatic function
Exclusion Criteria
* History of another malignancy within 3 years
* Active cerebral or meningeal disease related to the underlying malignancy
* Uncontrolled Grade 3 or higher infection
* Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR-T-cell therapy must be completed 8 weeks before first dose of study drug.
* Combination therapy only:
1. Known intolerance to corticosteroids
2. Uncontrolled psychoses
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Hayman, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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Stanford University School of Medicine
Palo Alto, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
Holden Comprehensive Cancer Center / University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Washington University in St Louis
St Louis, Missouri, United States
Weill Cornell Medicine
New York, New York, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester, New York, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGNBCMA-001
Identifier Type: -
Identifier Source: org_study_id