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 - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/05/086109

Enrollment

Registered

2025-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C900- Multiple myeloma

Interventions

Intervention1: Teclistamab: Teclistamab will be administered subcutaneously. Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participant diagnosed with RRMM as per IMWG definitions or investigator s discretion who have received at least 3 prior lines of therapy including a proteasome inhibitor, an anti CD 38 antibody and an immunomodulatory agent and have demonstrated disease progression on the last therapy 2. Documented evidence of progressive measurable disease on last line of therapy at screening based on investigator s determination of response by IMWG diagnostic criteria 3. Have an Eastern Cooperative Oncology Group ECOG performance status of 0 to 2 4. Contraceptive use by female participants should be consistent with local regulations. A female participant is eligible to participate if she is not pregnant or breastfeeding, and not a woman of child bearing potential WOCBP or is a WOCBP and using a contraceptive method that is highly effective 5. A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study treatment

Exclusion criteria

Exclusion criteria: 1. Participants who are not eligible to receive teclistamab as per the locally approved prescribing information 2. Received any prior B cell maturation antigen BCMA directed therapy Central nervous system CNS involvement or clinical signs of meningeal involvement of multiple myeloma- Stroke, transient ischemic attack, or seizure within 6 months prior to screening 3. Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study

Design outcomes

Primary

Measure	Time frame
Number of Participants with Treatment-Emergent Adverse Events (TEAE)sTimepoint: Up to approximately 7 months	—

Secondary

Measure	Time frame
Overall Response Rate (ORR)Timepoint: Up to approximately 6 months;Percentage of Participants With Best Response of Very Good Partial Response (VGPR) or BetterTimepoint: Up to approximately 6 months	—

Countries

India

Contacts

Public ContactDr Sanish Davis

Johnson and Johnson Pvt Ltd

sdavis20@its.jnj.com919820958943

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026