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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma (NCT07030517) is a Phase 4 interventional studying Multiple Myeloma, sponsored by Johnson & Johnson Private Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 75 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Multiple Myeloma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Teclistamab

Teclistamab will be administered subcutaneously.

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07030517), the sponsor (Johnson & Johnson Private Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07030517 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07030517?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07030517?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07030517. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07030517. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.