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NCT05050097Active, not recruitingPhase 1

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
166 (actual)
First submitted
10 Sept 2021
Start date
22 Sept 2021
Primary completion date
31 Mar 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05050097
EU CT number
2023-503620-60-00
EudraCT number
2020-004502-55

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 166
  • From 22 Sept 2021 to the primary completion date, 31 Mar 2025
  • 29 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • History of stroke or seizure within 6 months prior to the first dose of study treatment

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Vincents Hospital Melbourne
Coordinator of this site? Confirm its status
FitzroyAustraliaUnknown status
Alfred Health
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MelbourneAustraliaUnknown status
Gold Coast University Hospital
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SouthportAustraliaUnknown status
Wollongong Hospital
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WollongongAustraliaUnknown status
Antwerp University Hospital
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EdegemBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Institut Universitaire du Cancer Toulouse - Oncopole
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ToulouseFranceActive, not recruiting
University College Hospital - London
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Churchill Hospital
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OxfordUnited KingdomUnknown status
The Royal Marsden NHS Trust Sutton
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SurreyUnited KingdomUnknown status
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
University Hospital Maastricht
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MaastrichtNetherlandsActive, not recruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsActive, not recruiting
Emory University
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AtlantaUnited StatesUnknown status
University of Alabama Birmingham
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BirminghamUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Weill Cornell Medical College
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New YorkUnited StatesUnknown status
Mt. Sinai School of Medicine
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New YorkUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.