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 three 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 get SEA-BCMA and dexamethasone. In the third part, 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.

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 + Dexamethasone Combination Therapy
dexamethasoneSEA-BCMA + Dexamethasone Combination Therapy
pomalidomideSEA-BCMA + Pomalidomide/Dexamethasone Combination Therapy

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 three 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 get SEA-BCMA and dexamethasone. In the third part, 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.

Trial Arms

NameTypeDescriptionInterventions
SEA-BCMA MonotherapyExperimentalSEA-BCMA
  • SEA-BCMA
SEA-BCMA + Dexamethasone Combination TherapyExperimentalSEA-BCMA + dexamethasone
  • SEA-BCMA
  • dexamethasone
SEA-BCMA + Pomalidomide/Dexamethasone Combination TherapyExperimentalSEA-BCMA + dexamethasone + pomalidomide
  • SEA-BCMA
  • dexamethasone
  • pomalidomide

Eligibility Criteria

        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:

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

Primary Outcome Measures

Measure:Incidence of adverse events (AEs)
Time Frame:Through 30-37 days following last dose, up to approximately 3 years
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, up to approximately 3 years
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, up to approximately 3 years
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)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:The time from first documentation of OR to the first documentation of disease progression or death due to any cause
Measure:Duration of complete response (CR)
Time Frame:Up to approximately 4 years
Safety Issue:
Description:The time from first documentation of CR 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:Seagen Inc.

Trial Keywords

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

Last Updated

July 13, 2021