Multiple Myeloma Clinical Trial

A Safety Study of SEA-BCMA in Patients With Multiple Myeloma

Summary

This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of MM
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:

Parts A and D: Prior treatment with a BCMA-directed therapy
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:

Known intolerance to corticosteroids
Uncontrolled psychoses

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

83

Study ID:

NCT03582033

Recruitment Status:

Terminated

Sponsor:

Seagen Inc.

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There are 13 Locations for this study

See Locations Near You

Stanford University School of Medicine
Palo Alto California, 94304, United States
Rocky Mountain Cancer Centers - Aurora
Aurora Colorado, 80012, United States
University of Miami
Miami Florida, 33136, United States
Holden Comprehensive Cancer Center / University of Iowa
Iowa City Iowa, 52242, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Washington University in St Louis
Saint Louis Missouri, 63110, United States
Weill Cornell Medicine
New York New York, 10065, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester New York, 14642, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Texas Oncology - Austin Midtown
Austin Texas, 78705, United States
Texas Oncology - Northeast Texas
Tyler Texas, 75702, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

83

Study ID:

NCT03582033

Recruitment Status:

Terminated

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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