A Study of Talquetamab with Other Anticancer Therapies in Participants with Multiple Myeloma
Last Updated   May 4, 2023 - 00:00
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 1Researchers test a new drug or treatment in a small group of people for the first time to gather information on its safety, dosing, and side effects. -
Sites
sites -
Status
Recruiting
SUMMARY
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
CONDITIONS
- Multiple Myeloma
ELIGIBILITY
Inclusion Criteria:
- • Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- • Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
- • A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
- • Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Exclusion Criteria:
- • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- • Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
- • Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- • Known to be seropositive for human immunodeficiency virus
- • History of stroke or seizure within 6 months prior to the first dose of study treatment
DETAILS
LOCATIONS
Country (6) | City or Province (31) | Status |
United States | Atlanta, GA Emory University |
Recruiting
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United States | Birmingham, AL University of Alabama Birmingham |
Recruiting
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United States | Charlotte, NC Levine Cancer Institute |
Recruiting
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United States | Denver, CO Colorado Blood Cancer Institute |
Recruiting
|
United States | Hackensack, NJ Hackensack University Medical Center |
Recruiting
|
United States | Indianapolis, IN Indiana University |
Recruiting
|
United States | Milwaukee, WI Medical College Of Wisconsin |
Recruiting
|
United States | Nashville, TN Sarah Cannon Research Institute |
Recruiting
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United States | New York, NY Mt. Sinai School of Medicine |
Recruiting
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United States | New York, NY Weill Cornell Medical College |
Recruiting
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United States | Pittsburgh, PA University of Pittsburgh Medical Center |
Recruiting
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United States | San Francisco, CA University of California, San Francisco |
Recruiting
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United Kingdom | London University College Hospital London |
Recruiting
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United Kingdom | MANCHESTER The Christie Nhs Foundation Trust |
Recruiting
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United Kingdom | Oxford, OXF Churchill Hospital |
Recruiting
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United Kingdom | Surrey The Royal Marsden NHS Trust Sutton |
Recruiting
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Netherlands | Groningen, GR UMCG |
Recruiting
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Netherlands | Maastricht, LI Maastricht University Medical Centre |
Recruiting
|
Netherlands | Utrecht, UT UMCU |
Recruiting
|
France | NANTES CEDEX 1 CHU Nantes |
Recruiting
|
France | Pessac cedex CHU de Bordeaux - Hospital Haut-Leveque |
Recruiting
|
France | RENNES Chu Rennes - Hopital Pontchaillou |
Recruiting
|
France | TOULOUSE Cedex 9 Institut Universitaire du cancer de Toulouse-Oncopole |
Recruiting
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Belgium | Brussel, BRU Cliniques Universitaires St-Luc |
Recruiting
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Belgium | Edegem UZA |
Recruiting
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Belgium | Gent UZ Gent |
Recruiting
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Belgium | Leuven UZ Leuven |
Recruiting
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Australia | Fitzroy, VIC St. Vincent's Hospital Melbourne |
Recruiting
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Australia | Melbourne, VIC Alfred Health |
Recruiting
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Australia | Southport, QLD Gold Coast University Hospital |
Recruiting
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Australia | Wollongong, NSW Wollongong Hospital |
Recruiting
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