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A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Trial Status: active
The purpose of this study is to compare the efficacy of teclistamab in combination with
daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and
lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Inclusion Criteria
Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
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
A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
Exclusion Criteria
Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams [mg] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization
Had plasmapheresis within 28 days of randomization
Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone
Additional locations may be listed on ClinicalTrials.gov for NCT05552222.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not Available
Fairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not Available
Greenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not Available
Guilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not Available
New Haven
Yale University
Status: Active
Name Not Available
North Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Name Not Available
Stamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
