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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teclistamab | Experimental | Participants with RRMM eligible for receiving teclistamab will continue to receive study treatment as per the label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teclistamab | Drug | Teclistamab will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 2 years 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 2 years 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Private Limited Clinical Trial | Johnson & Johnson Private Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M S Ramaiah Medical College and Hospital | Recruiting | Bangalore | 560054 | India | ||
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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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| 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. | Up to approximately 2 years 1 month |
| St. Johns Medical College And Hospital |
| Recruiting |
| Bengaluru |
| 560034 |
| India |
| Post Graduate Institute of Medical Education And Research PGIMER | Recruiting | Chandigarh | 160012 | India |
| Bhagwan Mahaveer Cancer Hospital & Research Centre | Recruiting | Jaipur | 302017 | India |
| Tata Medical Center | Recruiting | Kolkata | 700156 | India |
| Tata Memorial Hospital | Recruiting | Mumbai | 400012 | India |
| KIMS-Kingsway Hospitals | Recruiting | Nagpur | 440001 | India |
| All India Institute of Medical Sciences | Recruiting | New Delhi | 110029 | India |
| Rajiv Gandhi Cancer Institute & Research Centre | Recruiting | New Delhi | 110085 | India |
| Jawaharlal Institute of Postgraduate Medical Education and Research | Recruiting | Puducherry | 605006 | India |
| Christian Medical College | Recruiting | Ratnagiri Kilminnal | 632517 | India |
| Regional Cancer Centre | Recruiting | Thiruvananthapuram | 695011 | India |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |