A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
Talquetamab: Talquetamab will be administered subcutaneously.
Daratumumab: Daratumumab will be administered subcutaneously.
Pomalidomide: Pomalidomide will be administered orally.
Dexamethasone: Dexamethasone will be administered orally or intravenously.
Study summary
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level \>= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain \>= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (\>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (\<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment
* Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received \>=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
* Documented evidence of progressive disease based on investigator's determination of response by the 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
Exclusion Criteria:
* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
* Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
* Received prior pomalidomide therapy
* A maximum cumulative dose of corticosteroids to \>=140 milligrams (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
* Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
Primary outcome measure(s)
Progression-Free Survival (PFS) — Up to 6 years 6 months PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.
Trial sites (216)
Facility
City
Region
Status
The University of Arizona Cancer Center
Tucson
Arizona
University of Arkansas for Medical Sciences
Little Rock
Arkansas
Norwalk Hospital-oncology
Norwalk
Connecticut
MedStar Georgetown University Hospital
Washington D.C.
District of Columbia
George Washington University
Washington D.C.
District of Columbia
Memorial Healthcare System
Hollywood
Florida
University of Miami Health System
Miami
Florida
University Of Illinois
Chicago
Illinois
University of Kansas
Westwood
Kansas
Tulane University Hospital & Clinics
New Orleans
Louisiana
Ochsner Health System
New Orleans
Louisiana
Johns Hopkins University
Baltimore
Maryland
Massachusetts General
Boston
Massachusetts
Boston University Medical Center
Boston
Massachusetts
University of Massachusetts Medical School
Worcester
Massachusetts
University of Michigan Health System
Ann Arbor
Michigan
University Of Minnesota
Minneapolis
Minnesota
University of Mississippi Medical Center
Jackson
Mississippi
Washington University School Of Medicine
St Louis
Missouri
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
NYU Langone Health
New York
New York
SUNY Upstate Medical University
Syracuse
New York
University of North Carolina
Chapel Hill
North Carolina
Levine Cancer Institute, Carolinas HealthCare System
Charlotte
North Carolina
Novant Health 1
Charlotte
North Carolina
Novant Health
Winston-Salem
North Carolina
Wake Forest Baptist Medical Center
Winston-Salem
North Carolina
University Hospitals Cleveland Medical Center
Cleveland
Ohio
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus
Ohio
OhioHealth
Columbus
Ohio
Thomas Jefferson University
Philadelphia
Pennsylvania
Medical University of South Carolina
Charleston
South Carolina
Baptist Cancer Center
Memphis
Tennessee
Houston Methodist Hospital
Houston
Texas
MD Anderson Cancer Center
Houston
Texas
Joe Arrington Cancer Research Treatment Center
Lubbock
Texas
Huntsman Cancer Institute
Salt Lake City
Utah
University of Virginia
Charlottesville
Virginia
Virginia Commonwealth University - Massey Cancer Center
Richmond
Virginia
Fred Hutchinson Cancer Research Center
Seattle
Washington
+ 176 more sites — see the full list on the official registry below.
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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