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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

Sponsored by Janssen Research & Development, LLC

About this trial

Last updated 23 days ago

Study ID

CR109237

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 3 years ago

What is this trial 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).

What are the participation requirements?

Yes

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

No

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

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Completed
Completed
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Completed

For more information, view the full study details:

NCT055522222022-000909-28