A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma

Sponsor
Johnson & Johnson Private Limited
Study ID
NCT07030517
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Teclistamab will be administered subcutaneously.

Study Details

The purpose of this study is to assess the safety of teclistamab in routine clinical practice when given as monotherapy in Indian participants with relapsed and refractory multiple myeloma (RRMM) (that is, a blood cancer that comes back after treatment or does not respond to treatment) who have previously received at least 3 prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-cluster of differentiation (CD)38 antibody (is a protein that fights infection) and whose disease have progressed on the last therapy.

Key Dates

Start date
May 22, 2025
Status verified
Jun 2026
Primary completion
Nov 3, 2026
Completion
Jun 20, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Teclistamab
    Participants with RRMM eligible for receiving teclistamab will continue to receive study treatment as per the label.

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events (TEAE)s [ Time Frame: Up to approximately 2 years 1 month ]

Central Contacts

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