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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.

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy
SEA-BCMA
 Drug: SEA-BCMA
Given by intravenous (IV) infusion
Experimental: Combination Therapy
SEA-BCMA + dexamethasone
 Drug: SEA-BCMA
Given by intravenous (IV) infusion

Drug: dexamethasone
Given orally or by IV infusion


Outcome Measures
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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 28 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


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

Locations
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United States, California
Stanford University School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Michaela Liedtke         
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Robert Rifkin         
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, Iowa
Holden Comprehensive Cancer Center / University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Yogesh Jethava         
United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Al-Ola Abdallah, MD         
United States, Missouri
Washington University in St Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Mark Schroeder         
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Ruben Niesvizky         
James P. Wilmot Cancer Center / University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Brea Lipe         
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Eugene, Oregon, United States, 97401
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Christopher Yasenchak         
United States, Texas
Texas Oncology - Austin Midtown Recruiting
Austin, Texas, United States, 78705
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Jason Melear         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Seattle Genetics Trial Information Support    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Damian Green, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Mary Campbell, MD Seattle Genetics, Inc.
More Information
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03582033    
Other Study ID Numbers: SGNBCMA-001
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 31, 2020

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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:
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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
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents