A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT03582033 |
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Recruitment Status :
Recruiting
First Posted : July 10, 2018
Last Update Posted : December 3, 2018
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Sponsor:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
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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. 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 |
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
Genetics Home Reference related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
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Experimental: SEA-BCMA
SEA-BCMA
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Drug: SEA-BCMA
Intravenous (IV) infusion every 2 weeks (or every 4 weeks if recommended by the Safety Monitoring Committee) |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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
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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.:
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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 |