A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma
NCT ID: NCT07030517
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
75 participants
INTERVENTIONAL
2025-05-22
2027-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Teclistamab
Participants with RRMM eligible for receiving teclistamab will continue to receive study treatment for 6 cycles. Assessments will be done 7 days after dose 4 of 6th cycle (end of treatment \[EOT\]) and participants will be followed up 1 month after the EOT. Participants receiving teclistamab at the time of study completion may continue to receive teclistamab, if in the opinion of their treating physician the participants continues to derive clinical benefit from continued treatment or have not progressed clinically.
Teclistamab
Teclistamab will be administered subcutaneously.
Interventions
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Teclistamab
Teclistamab will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented evidence of progressive measurable disease on last line of therapy at screening based on investigator's determination of response by IMWG diagnostic 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. 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
* A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study treatment
Exclusion Criteria
* Received any prior B cell maturation antigen (BCMA)-directed therapy
* Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma
* 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson Private Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Private Limited Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Private Limited
Locations
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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
Christian Medical College
Ratnagiri Kilminnal, , India
Regional Cancer Centre
Thiruvananthapuram, , India
Countries
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Central Contacts
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Other Identifiers
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64007957MMY4007
Identifier Type: OTHER
Identifier Source: secondary_id
64007957MMY4007
Identifier Type: -
Identifier Source: org_study_id