Clinical Trials /

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

NCT03582033

Description:

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. Part 1 of the study will find out how much SEA-BCMA should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
  • Official Title: A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: SGNBCMA-001
  • NCT ID: NCT03582033

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
SEA-BCMASEA-BCMA

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. Part 1 of the study will find out how much SEA-BCMA should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

Detailed Description

      This study is designed to evaluate the safety, tolerability, and antitumor activity of
      SEA-BCMA in adults with relapsed or refractory multiple myeloma (RRMM). The study will be
      conducted in 2 parts:

      Part 1 - Dose-escalation: Approximately 25 patients will be treated to evaluate the safety
      and tolerability of SEA-BCMA, and to identify the maximum tolerated dose (MTD) or optimal
      dose.

      Part 2 - Dose expansion: approximately 40 patients will be treated at the MTD or optimal dose
      to further characterize the safety and antitumor activity of SEA-BCMA.

      In both parts, SEA-BCMA will be administered at the assigned dose every 2 weeks (or every 4
      weeks if recommended by the Safety Monitoring Committee) by intravenous (IV) infusion.
      Patients may continue on treatment until disease progression or unacceptable toxicity.
    

Trial Arms

NameTypeDescriptionInterventions
SEA-BCMAExperimentalSEA-BCMA
  • SEA-BCMA

Eligibility Criteria

        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 targeted therapeutic

          -  Patients who are pregnant or breastfeeding

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants reporting one or more treatment-emergent adverse events (TEAEs)
Time Frame:Through 30-37 days following last dose
Safety Issue:
Description:AE grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03. Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant but not immediately life-threatening; Grade 4 - life-threatening consequences; Grade 5 - death related to AE

Secondary Outcome Measures

Measure:Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration)
Time Frame:Through 30-37 days following last dose
Safety Issue:
Description:
Measure:PK outcome: AUC (area under the serum concentration-time curve)
Time Frame:Through 84 days following first dose
Safety Issue:
Description:
Measure:Incidence of SEA-BCMA antitherapeutic antibodies (ATA)
Time Frame:Through 30-37 days following last dose
Safety Issue:
Description:
Measure:Best response per the IMWG uniform response criteria
Time Frame:Up to approximately 4 years
Safety Issue:
Description:International Myeloma Working Group (IMWG)
Measure:Objective response rate (ORR)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Measure:Duration of objective response (OR) and complete response (CR)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:The time from first documentation of CR or OR to the first documentation of disease progression or death due to any cause
Measure:Progression-free survival (PFS)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:The time from the start of study treatment to the first documentation of disease progression or death due to any cause
Measure:Overall survival (OS)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:The time from the start of study treatment to the date of death due to any cause

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Genetics, Inc.

Trial Keywords

  • RRMM
  • Antibodies, monoclonal
  • Antigens, BCMA
  • Immunotherapy
  • Hematologic diseases
  • Myeloma

Last Updated

January 15, 2020