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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 (MajesTEC-7)

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Titre complet:
A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Phase 3
Résumé:
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).
Description détaillée:
Non disponible
Traitements:
Drug : Teclistamab

Teclistamab will be administered as SC injection.

Drug : Daratumumab

Daratumumab will be administered as SC injection.

Drug : Lenalidomide

Lenalidomide will be administered orally.

Drug : Dexamethasone

Dexamethasone will be administered either orally or intravenously (IV).

Drug : Talquetamab

Talquetamab will be administered as SC injection.

Groupes d'étude:
Experimental : Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.
Experimental : Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.
Active Comparator : Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: None
Statut du recrutement:
En cours
Critères d'admissibilités:
usion 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
Lieux / Centres:

Tom Baker Cancer Center University of Calgary, Calgary, Alberta – En cours

Contacts:
Name: Study Contact
Phone: 844-434-4210
Email: [email protected]
Publications:
???
Date d’affichage:
Non disponible
Date de début:
2022-10-25
Dernière mise à jour:
2024-07-15
Nombre d'inscriptions anticipées:
1590
Date de fin prévue:
2033-10-28
Date de fin prévue de l'étude primaire:
2031-04-30
Condition:
Multiple Myeloma
Genre:
All
Âge:
18 Years-
Accepte des bénévoles en santé:
Non disponible
Pays participants:
Non disponible
Numéro d’identification:
NCT05552222
Autres numéros d'identification de l'étude:
CR109237
Comité de suivi des données:
Yes
Produit réglementé par la FDA (É-U):
Yes
IPD Sharing Statement :
???
Responsables de l’étude:
Sponsor
Commanditaires de l’étude:
lead_sponsor
Janssen Research & Development, LLC
Industry
Collaborators:
???
Chercheurs:
Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Protocol Registration and Results System:
???
Date de vérification:
2024-07-01