A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
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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 26, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: SEA-BCMA Drug: dexamethasone Drug: pomalidomide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 131 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 : | February 28, 2025 |
Estimated Study Completion Date : | February 28, 2026 |

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: SEA-BCMA
Given into the vein (IV; intravenously) Drug: dexamethasone Given by mouth (orally) or by IV Drug: pomalidomide Given orally |
- 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.
- 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
- Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Through up to 28 days following first dose ]To be summarized using descriptive statistics.
- 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.
- PK outcome: AUC (area under the serum concentration-time curve) [ Time Frame: Through 84 days following first dose ]To be summarized using descriptive statistics.
- Incidence of SEA-BCMA antitherapeutic antibodies (ATA) [ Time Frame: 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)
- 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) [ 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
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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Combination therapy only:
- Known intolerance to corticosteroids
- Uncontrolled psychoses

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
Contact: Seagen Trial Information Support | 866-333-7436 | clinicaltrials@seagen.com |
United States, California | |
Stanford University School of Medicine | Recruiting |
Palo Alto, California, United States, 94304 | |
Principal Investigator: Michaela Liedtke | |
United States, Colorado | |
Rocky Mountain Cancer Centers - Aurora | Recruiting |
Aurora, Colorado, United States, 80012 | |
Principal Investigator: Robert Rifkin | |
United States, Florida | |
University of Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Principal Investigator: James Hoffman | |
United States, Iowa | |
Holden Comprehensive Cancer Center / University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Principal Investigator: Michael Tomasson | |
United States, Kansas | |
University of Kansas Cancer Center | Recruiting |
Westwood, Kansas, United States, 66205 | |
Principal Investigator: Al-Ola Abdallah | |
United States, Missouri | |
Washington University in St Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Principal Investigator: Mark Schroeder | |
United States, New York | |
Weill Cornell Medicine | Recruiting |
New York, New York, United States, 10065 | |
Principal Investigator: Ruben Niesvizky | |
James P. Wilmot Cancer Center / University of Rochester Medical Center | Recruiting |
Rochester, New York, United States, 14642 | |
Principal Investigator: Brea Lipe | |
United States, Oregon | |
Willamette Valley Cancer Institute and Research Center | Recruiting |
Eugene, Oregon, United States, 97401 | |
Principal Investigator: Christopher Yasenchak | |
United States, Texas | |
Texas Oncology - Austin Midtown | Recruiting |
Austin, Texas, United States, 78705 | |
Principal Investigator: Jason Melear | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Principal Investigator: Damian Green |
Study Director: | Phoenix Ho, MD | Seagen Inc. |
Responsible Party: | Seagen Inc. |
ClinicalTrials.gov Identifier: | NCT03582033 |
Other Study ID Numbers: |
SGNBCMA-001 |
First Posted: | July 10, 2018 Key Record Dates |
Last Update Posted: | August 26, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
RRMM Antibodies, monoclonal Antigens, BCMA Immunotherapy |
Hematologic diseases Myeloma Seattle Genetics |
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 |
Pomalidomide 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 Immunologic Factors Angiogenesis Inhibitors Angiogenesis Modulating Agents |