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| Name | Class |
|---|---|
| Hope Foundation | OTHER |
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The purpose of this study is to investigate the sensitivity and accuracy of non-invasive MRD assessment using liquid biopsy (blood draw) and functional imaging (whole body MRI) in participants with new diagnosed and previously treated multiple myeloma. The long-term goal of this study is to investigate whether non-invasive methods for MRD assessment can replace bone marrow aspiration and biopsy in a substantial percentage of participants with multiple myeloma.
There is an unmet clinical need for an easier, non-invasive, and reliable method to perform MRD assessments that can be used in clinical trials and routine practice. The two non-invasive modalities that are most promising for MRD assessment are liquid biopsy to detect circulating tumor cells (CTCs) and functional imaging to detect focal myeloma lesions. However, there are no prospective data on the sensitivity and specificity of non-invasive MRD assessment with respect to the gold standard of bone marrow sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myeloma Group | Patients with newly diagnosed and previously treated multiple myeloma will receive bone marrow sampling and functional imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRD Assessment | Other | MRD assessment includes liquid biopsy and functional imaging. Liquid biopsy will be performed by the Adaptive ClonoSEQ® assay in peripheral blood. Functional imaging will be performed by whole body diffusion-weighted magnetic resonance imaging (WB-DWI). |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of non-invasive MRD assessment | MRD assessment includes liquid biopsy and functional imaging. | 6 months |
| Specificity of non-invasive MRD assessment | MRD assessment includes liquid biopsy and functional imaging. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of two MRD-testing algorithms | Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients | 6 months |
| Specificity of two MRD-testing algorithms |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed or previously treated myeloma who are initiating a new line of therapy will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Chakraborty Chakraborty, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital/Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
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Bone marrow aspirate and biopsy
Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients
| 6 months |
| Progression Free Survival | The progression-free survival (PFS) will be calculated of patients who are MRD-positive and MRD-negative on each modality (liquid biopsy, functional imaging, and bone marrow sampling) | 2 years |
| Overall Survival | The overall survival (OS) will be calculated of patients who are MRD-positive and MRD-negative on each modality (liquid biopsy, functional imaging, and bone marrow sampling) | 2 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |