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| ID | Type | Description | Link |
|---|---|---|---|
| H7I-MC-S028 | Other Identifier | Eli Lilly and Company | |
| 10001 | Other Identifier | Disarm Therapeutics |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer, bortezomib for multiple myeloma, oxaliplatin-based regimens for colorectal cancer, or vincristine for lymphoma.. Demographic data, medical history, electronic PROs, ClinROs blood biomarkers including NF-L, PGx DNA analyses and Bedside-QST will be assessed at Baseline. The Observation Period will initiate with the first dose of chemotherapy and conclude with the last dose of chemotherapy. During the Observation Period, participants will be evaluated for the development of CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will be measured at various timepoints corresponding with treatment regimen schedules throughout the observation period. The Post Chemotherapy Follow-up Period will begin with the first visit after the last dose of chemotherapy and conclude 6 months after the last dose of chemotherapy. During the Post Chemotherapy Follow-up Period, participants will be evaluated for CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will also be measured at the beginning and at the end of the Post-Chemotherapy Follow-up Period. PROs will be assessed electronically on a monthly basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer patients with weekly/biweekly paclitaxel regimen | |||
| Breast cancer patients receiving docetaxel regimen | |||
| Lymphoma patients receiving vincristine regimen | |||
| Multiple myeloma patients receiving bortezomib regimen | |||
| Colorectal cancer patients receiving oxaliplatin-based regimens |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy | Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy | Through study completion, 2 years |
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Inclusion Criteria:
All of the following criteria must be met in order to be enrolled in the study:
Age ≥18 years
Life expectancy ≥6 months
Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 CIPN (exception, patients with multiple myeloma treated with bortezomib, CTCAE Grade <=1)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Breast cancer only:
Lymphoma only:
Oxaliplatin-based regimens, Stage III colorectal cancer: Total of 6 months (planned minimum of 12 cycles). May consider Stage IV with minimal metastatic confirmed with Sponsor prior to enrollment
Bortezomib use in untreated multiple myeloma: Total of 4 months (planned minimum of 9 cycles)
Written informed consent given
Enrollment must be completed prior to receiving the first dose of chemotherapy
Exclusion Criteria:
Patients meeting ANY of the following criteria are not eligible for participation:
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The study will enroll approximately 200 participants from a total of approximately 10 sites in the United States. Each participant will participate for a duration of up to 1 year after the first dose of chemotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | ClinicalTrials.gov@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alpha Oncology Research LLC | Completed | DeBary | Florida | 32713 | United States | |
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Serum samples collected for measuring biomarkers
| University of Maryland School of Medicine |
| Recruiting |
| Baltimore |
| Maryland |
| 21201-1544 |
| United States |
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| Johns Hopkins University School of Medicine | Not yet recruiting | Baltimore | Maryland | 21287 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109-0400 | United States |
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| Mayo Clinic | Completed | Rochester | Minnesota | 55905-0002 | United States |
| Washington University Medical School | Completed | St Louis | Missouri | 63110 | United States |
| Ohio State University | Completed | Columbus | Ohio | 43212 | United States |
| University of Pensylvania Hospital | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Vermont Medical Center | Recruiting | Burlington | Vermont | 05401 | United States |
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| VCU Medical Center | Recruiting | Richmond | Virginia | 23298 | United States |
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