Overview

A Study to Compare Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) in Participants With Newly Diagnosed Multiple Myeloma

Status:
Not yet recruiting
Trial end date:
2031-07-07
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Daratumumab
Dexamethasone
Lenalidomide
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 female participant must agree not to be pregnant, breastfeeding, or planning to
become pregnant while enrolled in this study or within 3 months after the last dose of
study treatment

- A male 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 a cumulative dose of systemic corticosteroids equivalent to greater than or
equal to (>=) 20 milligrams (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 excipients

- Known contraindications to the use of daratumumab or lenalidomide per local
prescribing information