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

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ClinicalTrials.gov Identifier: NCT03582033
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: SEA-BCMA Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: SEA-BCMA
SEA-BCMA
Drug: SEA-BCMA
Intravenous (IV) infusion every 2 weeks (or every 4 weeks if recommended by the Safety Monitoring Committee)




Primary Outcome Measures :
  1. Number of participants reporting one or more treatment-emergent adverse events (TEAEs) [ Time Frame: Through 30-37 days following last dose ]
  2. Number of participants with Grade 3 or higher adverse events (AEs) [ Time Frame: Through 30-37 days following last dose ]
    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

  3. Number of participants reporting one or more serious adverse event (SAE) [ Time Frame: Through 30-37 days following last dose ]
  4. Number of participants with a treatment-related AE [ Time Frame: Through 30-37 days following last dose ]
  5. Number of participants with laboratory abnormalities by grade [ Time Frame: Through 30-37 days following last dose ]
    Grades for laboratory abnormalities will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03

  6. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Through up to 42 days following first dose ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration) [ Time Frame: Through 30-37 days following last dose ]
  2. PK outcome: AUC (area under the serum concentration-time curve) [ Time Frame: Through 84 days following first dose ]
  3. Incidence of SEA-BCMA antitherapeutic antibodies (ATA) [ Time Frame: Through 30-37 days following last dose ]
  4. Best response per the IMWG uniform response criteria [ Time Frame: Up to approximately 4 years ]
    International Myeloma Working Group (IMWG)

  5. 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

  6. Duration of objective response (OR) and complete response (CR) [ Time Frame: Up to approximately 4 years ]
    The time from first documentation of CR or OR to the first documentation of disease progression or death due to any cause

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582033


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: James Hoffman         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Mark Schroeder         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Mary Campbell, MD Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03582033     History of Changes
Other Study ID Numbers: SGNBCMA-001
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 29, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seattle Genetics, Inc.:
RRMM
Antibodies, monoclonal
Antigens, BCMA
Immunotherapy
Hematologic diseases
Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases