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| Name | Class |
|---|---|
| Adaptive Biotechnologies | INDUSTRY |
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The purpose of the study is to determine outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post Autologous Stem Cell Transplant (ASCT).
This non-interventional, cohort prospective research study will assess outcomes for Multiple Myeloma patients on maintenance single agent vs. doublet (IMiD + PI) combination chemotherapy post ASCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Maintenance After Autologous Stem Cell Transplant | Prospectively enrolled cohort of patients receiving single maintenance therapy with an immunomodulatory drug after Autologous Stem Cell Transplant for Multiple Myeloma |
| |
| Double Maintenance After Autologous Stem Cell Transplant | Prospectively enrolled cohort of patients receiving double maintenance therapy with the combination of an immunomodulatory drug and a proteasome inhibitor after Autologous Stem Cell Transplant for Multiple Myeloma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Stem Cell Transplant | Other | This observational study will compare outcomes of prospectively enrolled ASCT recipients receiving Single agent vs doublet maintenance chemotherapy post ASCT |
| Measure | Description | Time Frame |
|---|---|---|
| MRD conversion rate | To determine rate of MRD conversion (positive to negative) in MM patients receiving an immunomodulatory drug in combination with a proteasome inhibitor as maintenance therapy 1-year post transplant. | At 1 year after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) at 1 Year | PFS is defined as time from transplant to disease progression, death or last follow-up date, whichever comes first. PFS will be estimated by Kaplan-Meier method and 95% confidence interval | At 1 Years |
| Progression Free Survival (PFS) at 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Multiple Myeloma patients receiving treatment at Moffitt Cancer Center
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| Name | Affiliation | Role |
|---|---|---|
| Doris Hansen, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Clinical Trial Search | View source |
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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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| ID | Term |
|---|---|
| D000276 | Adjuvants, Immunologic |
| D061988 | Proteasome Inhibitors |
| ID | Term |
|---|---|
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Minimal Residual Disease (MRD) testing by Clonoseq will be performed in the peripheral blood of the patients at the same time points that MRD testing will be done in the bone marrow in addition to at 6 and 18 months.
Investigators will examine the impact gut microbiota on MRD status and racial ethnic differences in study population. Stool samples will be collected at baseline and 1- and 2-years post Autologous Stem Cell Transplant.
| Immunomodulatory Agent | Drug | ASCT recipients receiving maintenance therapy consisting of an Immunomodulatory agent (IMID) after ASCT transplant |
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| Proteasome Inhibitor | Drug | ASCT recipients receiving maintenance therapy with a proteasome inhibitor in combination with an immunomodulatory drug after ASCT transplant |
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PFS is defined as time from transplant to disease progression, death or last follow-up date, whichever comes first. PFS will be estimated by Kaplan-Meier method and 95% confidence interval |
| At 2 years |
| MRD by NGS Clonoseq testing | MRD testing by NGS Clonoseq in peripheral blood of participants and correlate with same testing in bone marrow | At 2 years |
| 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 |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |