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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582033
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE June 12, 2018
First Posted Date  ICMJE July 10, 2018
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2020)
  • Number of participants reporting one or more treatment-emergent adverse events (TEAEs) [ Time Frame: Through 30-37 days following last dose ]
  • 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
  • Number of participants reporting one or more serious adverse event (SAE) [ Time Frame: Through 30-37 days following last dose ]
  • Number of participants with a treatment-related AE [ Time Frame: Through 30-37 days following last dose ]
  • 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
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Through up to 28 days following first dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • Number of participants reporting one or more treatment-emergent adverse events (TEAEs) [ Time Frame: Through 30-37 days following last dose ]
  • 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
  • Number of participants reporting one or more serious adverse event (SAE) [ Time Frame: Through 30-37 days following last dose ]
  • Number of participants with a treatment-related AE [ Time Frame: Through 30-37 days following last dose ]
  • 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
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Through up to 42 days following first dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • Pharmacokinetic (PK) outcome: Cmax (maximum serum concentration) [ Time Frame: Through 30-37 days following last dose ]
  • PK outcome: AUC (area under the serum concentration-time curve) [ Time Frame: Through 84 days following first dose ]
  • Incidence of SEA-BCMA antitherapeutic antibodies (ATA) [ Time Frame: Through 30-37 days following last dose ]
  • Best response per the IMWG uniform response criteria [ Time Frame: Up to approximately 4 years ]
    International Myeloma Working Group (IMWG)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
Official Title  ICMJE A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma
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. 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 be given both SEA-BCMA and dexamethasone. Dexamethasone is a drug that can be used to treat multiple myeloma. The part will study whether SEA-BCMA and dexamethasone are safe when used together.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: SEA-BCMA
    Given by intravenous (IV) infusion
  • Drug: dexamethasone
    Given orally or by IV infusion
Study Arms  ICMJE
  • Experimental: Monotherapy
    SEA-BCMA
    Intervention: Drug: SEA-BCMA
  • Experimental: Combination Therapy
    SEA-BCMA + dexamethasone
    Interventions:
    • Drug: SEA-BCMA
    • Drug: dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2020)
185
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2018)
65
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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-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.
  • Patients who are pregnant or breastfeeding
  • Combination therapy only:

    1. Known intolerance to corticosteroids
    2. Uncontrolled psychoses
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03582033
Other Study ID Numbers  ICMJE SGNBCMA-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mary Campbell, MD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date July 31, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP