Multiple Myeloma Clinical Trial
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
Summary
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Full Description
Teclistamab is a full-size, immunoglobin G4 proline, alanine, alanine (IgG4-PAA) bispecific antibody that targets the cluster of differentiation 3 (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). Talquetamab is a full-size, humanized IgG4-PAA bispecific antibody designed to target the CD3 receptor complex on T cells and G protein-coupled receptor class C group 5 member D (GPRC5D), which is a 7-transmembrane receptor protein that is classified as a type C G protein-coupled receptor. DRd is an approved regimen for the treatment of participants with newly diagnosed, transplant-ineligible multiple myeloma. The primary hypothesis of this study is that Tec-DR and Tal-DR will significantly improve progression free survival (PFS) or the rate of sustained minimal residual disease (MRD)-negative complete response (CR) (greater than [>]12 months) compared with DRd in participants with newly diagnosed multiple myeloma who are ineligible or not intended for autologous stem cell transplant (ASCT) as initial therapy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up. Safety Assessment includes adverse events (AEs), laboratory test results, vital sign measurements, physical examination findings, assessment of Eastern Cooperative Oncology Group (ECOG) performance status grade, and immune effector cell associated encephalopathy (ICE) score (Tec-DR and Tal-DR).
Eligibility Criteria
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 3 months 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 40 milligrams [mg] of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=)20 mg of dexamethasone during the Screening Phase
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
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There are 33 Locations for this study
New South Wales , 2298, Australia
Wollongong , 2500, Australia
Haine-Saint-Paul, La Louviere , 7100, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Creteil , 94010, France
Lille , 59000, France
Nantes , 44093, France
Pessac cedex , 33604, France
Pierre-Benite , 69310, France
Toulouse , 31000, France
Bombay , 40001, India
Chandigarh , 16001, India
Jaipur , 30201, India
Kolkata , 70016, India
Nagpur , 44000, India
Pondicherry , 60500, India
Apeldoorn , 7334 , Netherlands
Nieuwegein , 3435 , Netherlands
Granada , 18014, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Palma de Mallorca , 07120, Spain
Salamanca , 37007, Spain
Falun , 791 8, Sweden
Lund , 221 8, Sweden
Stockholm , 141 8, Sweden
Örebro , 701 8, Sweden
Ankara , 06590, Turkey
Canterbury , CT1 3, United Kingdom
London , W2 1N, United Kingdom
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