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

Stopped early · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT03582033

Run by

Seagen Inc.

People needed

83

Starts

2018-11-01

Expected to finish

2023-11-09

Last updated by the study team

2024-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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