Teclistamab safety in Indian patients 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

This program will test teclistamab given alone to see if it is safe for Indian adults whose multiple myeloma has returned or not responded after at least three prior treatments, including a proteasome inhibitor, an anti‑CD38 antibody, and an immunomodulatory drug.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johnson & Johnson Private Limited (Industry-sponsored)
• Drugs / interventions: teclistamab
• Locations: 12 sites (Bangalore and 11 other locations)
• Trial ID: NCT07030517 on ClinicalTrials.gov

What this trial studies

This Phase 4, post‑marketing safety study gives teclistamab as a single agent to Indian participants with relapsed and refractory multiple myeloma who have progressed after at least three prior lines of therapy. Eligible participants have prior exposure to a proteasome inhibitor, an anti‑CD38 antibody, and an immunomodulatory agent, and an ECOG performance status of 0–2. The primary focus is on monitoring and recording safety outcomes in routine clinical practice across participating hospital sites in India. The study is sponsored by Johnson & Johnson Private Limited and enrolls patients at regional tertiary care centers.

Who should consider this trial

Good fit: Ideal candidates are Indian adults with relapsed or refractory multiple myeloma who have progressed on at least three prior lines of therapy including a proteasome inhibitor, an anti‑CD38 antibody, and an immunomodulatory drug, and who have ECOG performance status 0–2 and are not pregnant or breastfeeding.

Not a fit: Patients who have had fewer than three prior lines of therapy, who lack prior exposure to the specified drug classes, who have poor performance status (>2), or who are pregnant or breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could confirm that teclistamab is a safe, additional treatment option for heavily pretreated multiple myeloma patients in India.

How similar studies have performed: Earlier clinical trials of teclistamab have shown antimyeloma activity with a manageable safety profile and led to regulatory approvals, so this is a postmarketing safety evaluation in an Indian population.

Eligibility criteria

Inclusion Criteria:

* 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

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. 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

Where this trial is running

Bangalore and 11 other locations

• M S Ramaiah Medical College and Hospital — Bangalore, India (Recruiting)
• St. Johns Medical College And Hospital — Bengaluru, India (Recruiting)
• Post Graduate Institute of Medical Education And Research PGIMER — Chandigarh, India (Recruiting)
• Bhagwan Mahaveer Cancer Hospital & Research Centre — Jaipur, India (Recruiting)
• Tata Medical Center — Kolkata, India (Recruiting)
• Tata Memorial Hospital — Mumbai, India (Recruiting)
• KIMS-Kingsway Hospitals — Nagpur, India (Recruiting)
• All India Institute of Medical Sciences — New Delhi, India (Recruiting)
• Rajiv Gandhi Cancer Institute & Research Centre — New Delhi, India (Recruiting)
• Jawaharlal Institute of Postgraduate Medical Education and Research — Puducherry, India (Recruiting)
• Christian Medical College — Ratnagiri Kilminnal, India (Recruiting)
• Regional Cancer Centre — Thiruvananthapuram, India (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Multiple Myeloma