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

November 29, 2023 updated by: Seagen Inc.

A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory 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 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers - Aurora
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center / University of Iowa
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St Louis
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center / University of Rochester Medical Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology - Austin Midtown
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Northeast Texas
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parts A and B: SEA-BCMA Monotherapy
SEA-BCMA
Drug: SEA-BCMA
Given into the vein (IV; intravenously)
Experimental: Part C: SEA-BCMA + Dexamethasone Combination Therapy
SEA-BCMA + dexamethasone
Drug: SEA-BCMA
Given into the vein (IV; intravenously)
Drug: dexamethasone
Given by mouth (orally) or by IV
Experimental: Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy
SEA-BCMA + dexamethasone + pomalidomide
Drug: pomalidomide
Given orally
Drug: SEA-BCMA
Given into the vein (IV; intravenously)
Drug: dexamethasone
Given by mouth (orally) or by IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: Through 30-37 days following last dose, up to approximately 3 years
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through 30-37 days following last dose, up to approximately 3 years
Number of participants with laboratory abnormalities by grade
Time Frame: Through 30-37 days following last dose, up to approximately 3 years
Grades for laboratory abnormalities will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03
Through 30-37 days following last dose, up to approximately 3 years
Incidence of dose-limiting toxicities (DLTs)
Time Frame: Through up to 28 days following first dose
To be summarized using descriptive statistics.
Through up to 28 days following first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration)
Time Frame: Through 30-37 days following last dose, up to approximately 3 years
To be summarized using descriptive statistics.
Through 30-37 days following last dose, up to approximately 3 years
PK outcome: AUC (area under the serum concentration-time curve)
Time Frame: Through 84 days following first dose
To be summarized using descriptive statistics.
Through 84 days following first dose
Incidence of SEA-BCMA antitherapeutic antibodies (ATA)
Time Frame: Through 30-37 days following last dose, up to approximately 4 years
Through 30-37 days following last dose, up to approximately 4 years
Best response per the IMWG uniform response criteria
Time Frame: Up to approximately 5 years
International Myeloma Working Group (IMWG)
Up to approximately 5 years
Objective response rate (ORR)
Time Frame: Up to approximately 4 years
The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Up to approximately 4 years
Duration of objective response (OR)
Time Frame: Up to approximately 4 years
The time from first documentation of OR to the first documentation of disease progression or death due to any cause
Up to approximately 4 years
Duration of complete response (CR)
Time Frame: Up to approximately 4 years
The time from first documentation of CR to the first documentation of disease progression or death due to any cause
Up to approximately 4 years
Progression-free survival (PFS)
Time Frame: Up to approximately 4 years
The time from the start of study treatment to the first documentation of disease progression or death due to any cause
Up to approximately 4 years
Overall survival (OS)
Time Frame: Up to approximately 4 years
The time from the start of study treatment to the date of death due to any cause
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Jonathan Hayman, MD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

November 9, 2023

Study Completion (Actual)

November 9, 2023

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNBCMA-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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