Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Seattle Genetics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: SEA-BCMA
  • Drug: dexamethasone

Phase:

Phase 1

Eligibility


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:

      1. Known intolerance to corticosteroids

      2. Uncontrolled psychoses

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Reneth Tien
650-723-0646
Recruiting