Purpose

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 two parts. In the first part, 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 the second part of the study, participants will be given both SEA-BCMA and dexamethasone. Dexamethasone is a drug that can be used to treat multiple myeloma. The part will study whether SEA-BCMA and dexamethasone are safe when used together.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically confirmed diagnosis of multiple myeloma (MM)
  • Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
  • Must have MM that is relapsed or refractory and must not have other therapeutic options available known to provide clinical benefit in MM
  • Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
  • Life expectancy of greater than 3 months in the opinion of the investigator
  • Patients of childbearing potential or who can father children must agree to consistently use 2 effective forms of birth control for at least 6 months after the final dose of study drug administration
  • Adequate hematologic, renal, and hepatic function
  • 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 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio.

Exclusion Criteria

  • 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.
  • Patients who are pregnant or breastfeeding
  • Combination therapy only:
  • Known intolerance to corticosteroids
  • Uncontrolled psychoses

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Monotherapy
SEA-BCMA
  • Drug: SEA-BCMA
    Given by intravenous (IV) infusion
Experimental
Combination Therapy
SEA-BCMA + dexamethasone
  • Drug: SEA-BCMA
    Given by intravenous (IV) infusion
  • Drug: dexamethasone
    Given orally or by IV infusion

Recruiting Locations

University of Kansas Cancer Center
Westwood, Kansas 66205
Contact:
Seattle Genetics Trial Information Support
866-333-7436
clinicaltrials@seagen.com

More Details

Status
Recruiting
Sponsor
Seattle Genetics, Inc.

Study Contact

Seattle Genetics Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.