Multiple MyelomaPhase 4NCT07030517
A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma
A Phase 4 study testing Teclistamab in people with Multiple Myeloma, run by Johnson & Johnson Private Limited at 12 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Teclistamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesIndia
- Study dates
- 22 May 2025to 14 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
M S Ramaiah Medical College and Hospital
Bangalore, 560054
St. Johns Medical College And Hospital
Bengaluru, 560034
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, 302017
Tata Medical Center
Kolkata, 700156
Tata Memorial Hospital
Mumbai, 400012
KIMS-Kingsway Hospitals
Nagpur, 440001
All India Institute of Medical Sciences
New Delhi, 110029
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, 110085
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, 605006
Christian Medical College
Ratnagiri Kilminnal, 632517
Regional Cancer Centre
Thiruvananthapuram, 695011
About this study
Official title: 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
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.
- Conditions
- Multiple Myeloma
- Being tested
- Teclistamab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Also called JNJ-64007957
Teclistamab will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Teclistamab | Experimental | Participants with RRMM eligible for receiving teclistamab will continue to receive study treatment as per the label. Receives: Drug: Teclistamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 2 years 1 month
Secondary outcomes (2)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a 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.
Measured: Up to approximately 2 years 1 month
Percentage of Participants With Best Response of Very Good Partial Response (VGPR) or Better
VGPR or better response rate is defined as the percentage of participants who achieve a response of VGPR or better response (sCR, CR and VGPR) as per investigator assessment according to the IMWG response criteria.
Measured: Up to approximately 2 years 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start22 May 2025
- Primary completion12 Feb 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Private Limited Clinical Trial, Study director, Johnson & Johnson Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030517
- Sponsor's protocol ID
- 64007957MMY4007
- Status last verified
- Nov 2026
- First submitted
- 12 Jun 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07030517
- Acronym / sponsor ID
- 64007957MMY4007
- Conditions
- Multiple Myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Johnson & Johnson Private LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- 12 Feb 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teclistamab | Experimental | Drug: TeclistamabParticipants with RRMM eligible for receiving teclistamab will continue to receive study treatment as per the label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabAlso: JNJ-64007957Teclistamab will be administered subcutaneously. | Drug | Teclistamab |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (TEAE)s
Time frame: Up to approximately 2 years 1 month
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.
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to approximately 2 years 1 month
Percentage of Participants With Best Response of Very Good Partial Response (VGPR) or Better
Time frame: Up to approximately 2 years 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Private Limited Clinical Trial study director
Johnson & Johnson Private Limited
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teclistamab in people with Multiple Myeloma, run by Johnson & Johnson Private Limited at 12 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (TEAE)s (time frame: Up to approximately 2 years 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.