Status:

RECRUITING

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

Lead Sponsor:

Janssen Research & Development, LLC

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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) ...

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 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

Key Trial Info

Start Date :

October 25 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 28 2033

Estimated Enrollment :

1590 Patients enrolled

Trial Details

Trial ID

NCT05552222

Start Date

October 25 2022

End Date

October 28 2033

Last Update

April 13 2026

Active Locations (263)

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Page 1 of 66 (263 locations)

1

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

2

University of Arizona Cancer Center

Tucson, Arizona, United States, 85719

3

UCSF Fresno

Clovis, California, United States, 93611

4

City of Hope Duarte

Duarte, California, United States, 91010