RecruitingPhase 4NCT07030517

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

An Open Label, Multicenter, Phase IV Study of Teclistamab to Evaluate Its Safety in Indian Participants With Relapsed and Refractory Multiple Myeloma Who Have Previously Received at Least 3 Prior Lines of Therapy Including an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 Antibody and Have Demonstrated Disease Progression on the Last Therapy


Sponsor

Johnson & Johnson Private Limited

Enrollment

75 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety of teclistamab (a bispecific antibody that targets multiple myeloma cells) specifically in Indian patients with multiple myeloma that has relapsed (come back) or stopped responding to prior treatments. **You may be eligible if:** - You have multiple myeloma that has relapsed or become resistant to treatment - You have received at least 3 prior lines of therapy, including a proteasome inhibitor, an anti-CD38 antibody (such as daratumumab), and an immunomodulatory drug (such as lenalidomide) - Your disease is currently progressing - You are in reasonably good physical health - You are willing to use effective contraception **You may NOT be eligible if:** - You have active, uncontrolled infection - You have significant organ damage - You are pregnant or breastfeeding - You have had certain prior treatments that would interact with teclistamab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTeclistamab

Teclistamab will be administered subcutaneously.


Locations(12)

M S Ramaiah Medical College and Hospital

Bangalore, India

St. Johns Medical College And Hospital

Bengaluru, India

Post Graduate Institute of Medical Education And Research PGIMER

Chandigarh, India

Bhagwan Mahaveer Cancer Hospital & Research Centre

Jaipur, India

Tata Medical Center

Kolkata, India

Tata Memorial Hospital

Mumbai, India

KIMS-Kingsway Hospitals

Nagpur, India

All India Institute of Medical Sciences

New Delhi, India

Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, India

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, India

Christian Medical College

Ratnagiri Kilminnal, India

Regional Cancer Centre

Thiruvananthapuram, India

View Full Details on ClinicalTrials.gov

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NCT07030517


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