A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
Talquetamab: Talquetamab will be administered as a SC injection.
Pomalidomide: Pomalidomide will be administered orally.
Teclistamab: Teclistamab will be administered as a SC injection.
Elotuzumab: Elotuzumab will be administered intravenously.
Dexamethasone: Dexamethasone will be administered either orally or intravenously.
Bortezomib: Bortezomib will be administered as a SC injection.
Study summary
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level \>= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (\>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (\<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment
* Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
Exclusion Criteria:
* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
* Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
* A maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
* Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Primary outcome measure(s)
Progression Free Survival (PFS) — Up to 3 years 5 months PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.
Trial sites (242)
Facility
City
Region
Status
UCSF Fresno
Clovis
California
UCLA
Santa Monica
California
Yale University School Of Medicine
New Haven
Connecticut
Medical Oncology Hematology Consultants, PA
Newark
Delaware
Memorial Healthcare System
Hollywood
Florida
Moffitt Cancer Center
Tampa
Florida
Winship Cancer Institute Emory University
Atlanta
Georgia
City of Hope Cancer Center
Newnan
Georgia
Kootenai Health
Coeur d'Alene
Idaho
Loyola University Medical Center
Maywood
Illinois
University of Iowa Health Care
Waukee
Iowa
Norton Cancer Institute
Louisville
Kentucky
Our Lady of the Lake Hospital
Baton Rouge
Louisiana
Luminis Health Center for Cancer and Blood Disorders
Annapolis
Maryland
University of Maryland School of Medicine
Baltimore
Maryland
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore
Maryland
University of Michigan
Ann Arbor
Michigan
Henry Ford Cancer Institute
Detroit
Michigan
Henry Ford Health Providence Southfield Hospital
Southfield
Michigan
University Of Minnesota
Minneapolis
Minnesota
Mayo Clinic Rochester
Rochester
Minnesota
Regions Hospital
Saint Paul
Minnesota
University of Nebraska
Omaha
Nebraska
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack
New Jersey
Roswell Park Cancer Institute
Buffalo
New York
Weill Cornell Medical College
New York
New York
SUNY Upstate Medical University
Syracuse
New York
Duke University Medical Center
Durham
North Carolina
Gabrail Cancer Center
Canton
Ohio
Louis Stokes Cleveland VA Med Ctr
Cleveland
Ohio
Cleveland Clinic
Cleveland
Ohio
Oregon Health And Science University
Portland
Oregon
Penn State Milton S Hershey Medical Ctr
Hershey
Pennsylvania
Thomas Jefferson University
Philadelphia
Pennsylvania
West Penn Hospital
Pittsburgh
Pennsylvania
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh
Pennsylvania
Medical University of South Carolina
Charleston
South Carolina
Bon Secours Saint Francis Cancer Center
Greenville
South Carolina
UT Southwestern Parkland Hospital
Dallas
Texas
+ 202 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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