A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/3/2019 |
Start Date: | November 1, 2018 |
End Date: | June 2022 |
Contact: | Seattle Genetics Trial Information Support |
Email: | clinicaltrials@seagen.com |
Phone: | 866-333-7436 |
A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma
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.
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.
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.
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.
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.
We found this trial at
4
sites
Miami, Florida 33124
(305) 284-2211
Principal Investigator: James Hoffman
Phone: 866-333-7436
University of Miami A private research university with more than 15,000 students from around the...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Damian Green, MD
Phone: 866-333-7436
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Mark Schroeder
Phone: 866-333-7436
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Westwood, Kansas 66205
Principal Investigator: Al-Ola Abdallah, MD
Phone: 866-333-7436
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