A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
NCT ID: NCT05050097
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
166 participants
INTERVENTIONAL
2021-09-22
2027-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Regimen A: Talquetamab + Carfilzomib
Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.
Talquetamab
Talquetamab will be administered subcutaneously.
Carfilzomib
Carfilzomib will be administered as an IV infusion.
Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib
Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.
Talquetamab
Talquetamab will be administered subcutaneously.
Carfilzomib
Carfilzomib will be administered as an IV infusion.
Daratumumab SC
Daratumumab will be administered subcutaneously.
Treatment Regimen C: Talquetamab + Lenalidomide
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.
Talquetamab
Talquetamab will be administered subcutaneously.
Lenalidomide
Lenalidomide will be self-administered orally.
Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.
Talquetamab
Talquetamab will be administered subcutaneously.
Daratumumab SC
Daratumumab will be administered subcutaneously.
Lenalidomide
Lenalidomide will be self-administered orally.
Treatment Regimen E: Talquetamab + Pomalidomide
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.
Talquetamab
Talquetamab will be administered subcutaneously.
Pomalidomide
Pomalidomide will be self-administered orally.
Interventions
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Talquetamab
Talquetamab will be administered subcutaneously.
Carfilzomib
Carfilzomib will be administered as an IV infusion.
Daratumumab SC
Daratumumab will be administered subcutaneously.
Lenalidomide
Lenalidomide will be self-administered orally.
Pomalidomide
Pomalidomide will be self-administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mt. Sinai School of Medicine
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
St Vincents Hospital Melbourne
Fitzroy, , Australia
Alfred Health
Melbourne, , Australia
Gold Coast University Hospital
Southport, , Australia
Wollongong Hospital
Wollongong, , Australia
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZA
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHU Nantes
Nantes, , France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, , France
Chu Rennes Hopital Pontchaillou
Rennes, , France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse, , France
UMCG
Groningen, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
UMCU
Utrecht, , Netherlands
University College Hospital London
London, , United Kingdom
The Christie Nhs Foundation Trust
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
The Royal Marsden NHS Trust Sutton
Surrey, , United Kingdom
Countries
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Other Identifiers
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64407564MMY1004
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004502-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503620-60-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108946
Identifier Type: -
Identifier Source: org_study_id