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
Trial Status: active
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).
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 6months 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
Additional locations may be listed on ClinicalTrials.gov for NCT06208150.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: River Sween
Phone: 310-633-8400
Email: RSween@mednet.ucla.edu
Connecticut
Greenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not AvailableGuilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not AvailableNew Haven
Yale University
Status: Active
Name Not AvailableNorth Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Name Not AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableFlorida
Tampa
Moffitt Cancer Center
Status: Active
Contact: Kenneth H. Shain
Phone: 813-745-3907
Email: ken.shain@moffitt.org
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableIowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Approved
Name Not AvailableMaryland
Baltimore
University of Maryland/Greenebaum Cancer Center
Status: Active
Contact: Stephanie Colbourn
Phone: 410-328-7511
Email: stephanie.colbourn@umm.edu
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not AvailableMichigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not AvailableMinnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not AvailableRochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableNebraska
Omaha
University of Nebraska Medical Center
Status: Active
Contact: Debbie Vidlak
Phone: 402-559-7507
Email: dvidlak@unmc.edu
New Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Status: Active
Name Not AvailableNew Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not AvailableNew York
Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not AvailableNorth Carolina
Durham
Duke University Medical Center
Status: Active
Name Not AvailableOhio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not AvailableOregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not AvailablePennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not AvailablePittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not AvailableSouth Carolina
Charleston
Medical University of South Carolina
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableUtah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not AvailableVirginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not AvailableWashington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationJanssen Pharmaceuticals
- Primary ID64407564MMY3009
- Secondary IDsNCI-2024-04424, 2022-502446-27-00
- ClinicalTrials.gov IDNCT06208150