Multiple Myeloma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

176

Study ID:

NCT05050097

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 35 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35294, United States
University of California, San Francisco
San Francisco California, 94143, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Emory University
Atlanta Georgia, 30322, United States
Indiana University
Indianapolis Indiana, 46202, United States
University of Kansas Cancer Center
Westwood Kansas, 66160, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Mt. Sinai School of Medicine
New York New York, 10029, United States
Weill Cornell Medical College
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Alfred Health
Melbourne , 3004, Australia
Gold Coast University Hospital
Southport , 4215, Australia
Wollongong Hospital
Wollongong , 2500, Australia
Cliniques Universitaires St-Luc
Brussel , 1200, Belgium
UZA
Edegem , 2650, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Centre Leon Bérard
Lyon Cedex 8 , 69373, France
CHU Nantes
Nantes Cedex 1 , 44093, France
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac cedex , 33604, France
Chu Rennes - Hopital Pontchaillou
Rennes , 35000, France
Institut Universitaire du cancer de Toulouse-Oncopole
TOULOUSE Cedex 9 , 31059, France
UMCG
Groningen , 9713 , Netherlands
Maastricht University Medical Centre
Maastricht , 6229 , Netherlands
UMCU
Utrecht , 3584 , Netherlands
University College Hospital London
London , W1T 7, United Kingdom
The Christie Nhs Foundation Trust
Manchester , M20 4, United Kingdom
Churchill Hospital
Oxford , OX3 7, United Kingdom
The Royal Marsden NHS Trust Sutton
Surrey , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

176

Study ID:

NCT05050097

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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