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

Phase 3

Recruiting

Conditions: Kahler's disease
Multiple Myeloma
10018865

Registration Number: NL-OMON56272

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion 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

Exclusion Criteria:
- Received any prior therapy for multiple myeloma or smoldering myeloma other
than a short course of corticosteroids (not to exceed 40 milligrams [mg] of
dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg
dexamethasone or equivalent). In addition, received a cumulative dose of
systemic corticosteroids equivalent to greater than or equals to (>=)20 mg of
dexamethasone during the Screening Phase
- 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
- Myeloma Frailty Index of >=2 with the exception of participants who have a
score of 2 based on age alone

For a full list of exclusion criteria, please refer to section 5.2 of the study
protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Outcome Measure:<br /><br>1. Progression Free Survival (PFS) from randomization to the date of disease<br /><br>progression or death (Up to 9 years). PFS is defined as the duration from the<br /><br>date of randomization to either progressive disease or death, whichever comes<br /><br>first. Disease progression will be determined according to the International<br /><br>Myeloma Working Group (IMWG) response criteria.<br /><br>2. Complete Response (CR) or Better. From randomization up to 9 years. CR or<br /><br>better is defined as the percentage of participants achieving CR or stringent<br /><br>complete response (sCR) prior to subsequent antimyeloma therapy in accordance<br /><br>with the IMWG criteria during or after the study treatment.<br /><br></p><br>

Secondary Outcome Measures