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)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Lenalidomide; Drug: Talquetamab; Drug: Teclistamab; Drug: Daratumumab; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05552222

2023-503442-30-00 (Registry Identifier)

CR109237

2022-000909-28 (EudraCT Number)

64007957MMY3005 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 1,590 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,590 participants in 3 patient groups

Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)

Experimental group

Description:

Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.

Treatment:

Drug: Daratumumab

Drug: Teclistamab

Drug: Lenalidomide

Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)

Experimental group

Description:

Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.

Treatment:

Drug: Daratumumab

Drug: Talquetamab

Drug: Lenalidomide

Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)

Active Comparator group

Description:

Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.

Treatment:

Drug: Dexamethasone

Drug: Daratumumab

Drug: Lenalidomide