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

Seagen

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: dexamethasone; Drug: pomalidomide; Drug: SEA-BCMA

Study type: Interventional

Funder types: Industry

Identifiers

NCT03582033

SGNBCMA-001

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. Known intolerance to corticosteroids
  2. Uncontrolled psychoses

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 3 patient groups

Parts A and B: SEA-BCMA Monotherapy

Experimental group

Description:

SEA-BCMA

Treatment:

Drug: SEA-BCMA

Part C: SEA-BCMA + Dexamethasone Combination Therapy

Experimental group

Description:

SEA-BCMA + dexamethasone

Treatment:

Drug: SEA-BCMA

Drug: dexamethasone

Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy

Experimental group

Description:

SEA-BCMA + dexamethasone + pomalidomide

Treatment:

Drug: SEA-BCMA

Drug: pomalidomide

Drug: dexamethasone