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

Phase 4

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Teclistamab

• Registration Number: NCT07030517
• Lead Sponsor: Johnson & Johnson Private Limited

Brief Summary

The purpose of this study is to assess the safety of teclistamab in 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-22
• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Primary Completion: 2026-11-03
• Study Completion: 2027-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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
• Documented evidence of progressive measurable disease on last line of therapy at screening based on investigator's determination of response by IMWG diagnostic criteria
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• 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
• A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study treatment

Exclusion Criteria

• Participants who are not eligible to receive teclistamab as per the locally approved prescribing information
• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teclistamab	Teclistamab	Participants with RRMM eligible for receiving teclistamab will continue to receive study treatment for 6 cycles. Assessments will be done 7 days after dose 4 of 6th cycle (end of treatment \[EOT\]) and participants will be followed up 1 month after the EOT. Participants receiving teclistamab at the time of study completion may continue to receive teclistamab, if in the opinion of their treating physician the participants continues to derive clinical benefit from continued treatment or have not progressed clinically.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Emergent Adverse Events (TEAE)s	Up to approximately 7 months	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are AEs with onset during the treatment or that are a consequence of a preexisting condition that has worsened since the first dose of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any AE that is considered treatment-related regardless of the start date of the event. TEAEs reported will include all serious and non-serious adverse events.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to approximately 6 months	ORR is defined as the percentage of participants who have a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) or better per investigator assessment according to the International Myeloma Working Group (IMWG) response criteria.
Percentage of Participants With Best Response of Very Good Partial Response (VGPR) or Better	Up to approximately 6 months	VGPR or better response rate is defined as the percentage of participants who achieve a best response of VGPR or better response (sCR, CR and VGPR) as per investigator assessment according to the IMWG response criteria.

Trial Locations

Locations (3)

Bhagwan Mahaveer Cancer Hospital & Research Centre; 🇮🇳 Jaipur, India

Tata Medical Center; 🇮🇳 Kolkata, India

KIMS-Kingsway Hospitals; 🇮🇳 Nagpur, India