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

Who is this study for? Patients with multiple myeloma
What treatments are being studied? Talquetamab
Status: Active_not_recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama Birmingham
Birmingham
California
University of California San Francisco
San Francisco
Colorado
Colorado Blood Cancer Institute
Denver
Georgia
Emory University
Atlanta
Indiana
Indiana University
Indianapolis
North Carolina
Levine Cancer Institute
Charlotte
New Jersey
Hackensack University Medical Center
Hackensack
New York
Mt. Sinai School of Medicine
New York
Weill Cornell Medical College
New York
Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh
Tennessee
Tennessee Oncology
Nashville
Wisconsin
Medical College Of Wisconsin
Milwaukee
Other Locations
Australia
St Vincents Hospital Melbourne
Fitzroy
Alfred Health
Melbourne
Gold Coast University Hospital
Southport
Wollongong Hospital
Wollongong
Belgium
Cliniques Universitaires St-Luc
Brussels
UZA
Edegem
UZ Gent
Ghent
UZ Leuven
Leuven
France
CHU Nantes
Nantes
CHU de Bordeaux - Hospital Haut-Leveque
Pessac
Chu Rennes Hopital Pontchaillou
Rennes
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse
Netherlands
UMCG
Groningen
Maastricht University Medical Centre
Maastricht
UMCU
Utrecht
United Kingdom
University College Hospital London
London
The Christie Nhs Foundation Trust
Manchester
Churchill Hospital
Oxford
The Royal Marsden NHS Trust Sutton
Surrey
Time Frame
Start Date: 2021-09-22
Completion Date: 2027-04-07
Participants
Target number of participants: 166
Treatments
Experimental: 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.
Experimental: 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.
Experimental: Treatment Regimen C: Talquetamab + Lenalidomide
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.
Experimental: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.
Experimental: Treatment Regimen E: Talquetamab + Pomalidomide
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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