NCT07030517Active, not recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 12 Jun 2025
- Start date
- 22 May 2025
- Primary completion date
- 12 Feb 2027
- Lead sponsor
- Johnson & Johnson Private Limited
- Diseases
- Multiple myeloma
- NCT number
- NCT07030517
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 75
- From 22 May 2025 to the primary completion date, 12 Feb 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any prior B cell maturation antigen (BCMA)-directed therapy
- 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
Other
- Participants who are not eligible to receive teclistamab as per the locally approved prescribing information
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M S Ramaiah Medical College and Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| St. Johns Medical College And Hospital Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| Post Graduate Institute of Medical Education and Research (PGIMER) Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| Bhagwan Mahaveer Cancer Hospital & Research Centre Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| Tata Medical Center Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Kims-Kingsway Hospitals Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Rajiv Gandhi Cancer Institute & Research Centre Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Jawaharlal Institute of postgraduate medical education and research Coordinator of this site? Confirm its status | Puducherry | India | Unknown status |
| Christian Medical College Coordinator of this site? Confirm its status | Ratnagiri Kilminnal | India | Unknown status |
| Regional Cancer Centre Coordinator of this site? Confirm its status | Thiruvananthapuram | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.