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The purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the KarMMa-9 (CA089-1043) Phase 3 clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving idecabtagene vicleucel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idecabtagene vicleucel | Drug | As per CA089-1043 study protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant adverse events | Monthly from months 4-18, every 2 months from months 19-59, and annually from month year 5 to 15 | |
| Number of participants with positive replication-competent lentivirus test results | At 4, 7, 13, and 25 months, and annually up to 15 years | |
| Persistent vector sequence monitoring | Months 7-18 and annually from years 5-15 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Monthly up to 18 months and every two months after month 19 up to 15 years | |
| Overall survival (OS) | Every 3 months up to month 60, annually thereafter up to 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with newly diagnosed multiple myeloma (NDMM) who had a suboptimal response after autologous stem cell transplantation (ASCT) and who were treated with idecabtagene vicleucel in the KarMMa-9 (CA089-1043) Phase 3 clinical trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | Jeonranamdo | 58128 | South Korea |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Number of participants that achieve complete response or stringent complete response | At months 4-18, every 2 months from months 19-59, and annually from years 5-15 |
| Health-related quality of life (HRQoL) measured by the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire | At months 4-18, every 2 months from months 19-59, and annually from years 5-15 |
| Health-related quality of life (HRQoL) measured by the European Organization for Research and Treatment of Cancer assessment of quality of life of myeloma patients (EORTC QLQ-MY20) questionnaire | At months 4-18, every 2 months from months 19-59, and annually from years 5-15 |
| Health-related quality of life (HRQoL) measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire | At months 4-18, every 2 months from months 19-59, and annually from years 5-15 |
| Seoul National University Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 03080 | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
|
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 06591 | South Korea |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
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| ID | Term |
|---|---|
| C000715380 | idecabtagene vicleucel |
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