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
1 other identifier
interventional
75
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 multiple-myeloma
Started May 2025
Shorter than P25 for phase_4 multiple-myeloma
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2025
CompletedFirst Submitted
Initial submission to the registry
June 12, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 20, 2027
April 14, 2026
April 1, 2026
1.5 years
June 12, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Treatment-Emergent Adverse Events (TEAE)s
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.
Up to approximately 2 years 1 month
Secondary Outcomes (2)
Overall Response Rate (ORR)
Up to approximately 2 years 1 month
Percentage of Participants With Best Response of Very Good Partial Response (VGPR) or Better
Up to approximately 2 years 1 month
Study Arms (1)
Teclistamab
EXPERIMENTALParticipants with RRMM eligible for receiving teclistamab will continue to receive study treatment as per the label.
Interventions
Teclistamab will be administered subcutaneously.
Eligibility Criteria
You may qualify if:
- Participant with diagnosed 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 disease on last line of therapy based on investigator's determination of response by IMWG response 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 regarding the methods of contraception for those participating in clinical studies. 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 (with a failure rate of less than \[\<\] 1 percent \[%\] per year), preferably with low user dependency, during the treatment period and for a period of 6 months after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during study period
- A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study treatment
You may not qualify if:
- 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. If either is suspected, negative whole brain MRI, and lumbar cytology are required
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
M S Ramaiah Medical College and Hospital
Bangalore, 560054, India
St. Johns Medical College And Hospital
Bengaluru, 560034, India
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, 302017, India
Tata Medical Center
Kolkata, 700156, India
Tata Memorial Hospital
Mumbai, 400012, India
KIMS-Kingsway Hospitals
Nagpur, 440001, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, 110085, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, 605006, India
Christian Medical College
Ratnagiri Kilminnal, 632517, India
Regional Cancer Centre
Thiruvananthapuram, 695011, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Private Limited Clinical Trial
Johnson & Johnson Private Limited
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2025
First Posted
June 22, 2025
Study Start
May 22, 2025
Primary Completion (Estimated)
November 3, 2026
Study Completion (Estimated)
June 20, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.