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Insufficient pace of enrollment due to changes in MM SOC practices
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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Massachusetts General Hospital | OTHER |
| Weill Medical College of Cornell University | OTHER |
| City of Hope Medical Center |
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This study will collect bone marrow (BM) aspirate samples from patients with relapsed refractory multiple myeloma (RRMM) prior to the start of a new treatment regimen for the purposes of prospectively measuring single-cell mass accumulation rate (MAR) as a biomarker of patient response to that regimen.
The primary study objective is to explore whether the single-cell MAR biomarker can predict patient response in RRMM patients. In order to enable this primary objective, two patient cohorts will be required. First, a small vanguard cohort of patients with treatment naïve disease to define drug concentrations used for testing, and second, the main RRMM patient cohort. Data will be collected to estimate the biomarker's predictive properties (accuracy, sensitivity, specificity), and to support improvement of the MAR biomarker through additional research and discovery within the study dataset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanguard | (CLOSED TO ENROLLMENT) Bone marrow (BM) from this cohort of up to 30 treatment naïve subjects with a diagnosis of multiple myeloma (MM) will first be used to define sample processing pipeline performance and optimal drug dosages before sites on the study proceed to mass accumulation rate (MAR) testing of BM from the relapsed/refractory MM (RRMM) subject cohort. | ||
| Relapsed/Refractory MM | BM from this cohort of 100 relapsed subjects with a diagnosis of MM will be used to test the MAR assay's accuracy of condition by matching conditions tested in vitro to the patient's planned course of therapy. This is the main study cohort described in the Eligibility section. |
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| Measure | Description | Time Frame |
|---|---|---|
| Best Response 4 months | The best International Myeloma Working Group (IMWG) response of each patient over 4 months of therapy | 0-4 months |
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Inclusion Criteria:
(CLOSED) *For patients in the Vanguard cohort*
1. Treatment naïve disease with BM clinically indicated
*For patients in the RRMM cohort*
Exclusion Criteria:
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Patient's pursuing initial care for their multiple myeloma at one of the 6 study sites
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| Name | Affiliation | Role |
|---|---|---|
| Nikhil C Munshi, M.D. | Dana-Farber Cancer Institute | Principal Investigator |
| Cara Rosenbaum, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States | ||
| Massachusetts General Hospital |
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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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| OTHER |
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| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Weill Cornell Medicine - New York Presbyterian | New York | New York | 10065 | United States |
| 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 |