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The primary purpose of this protocol is to create a registry of patients with plasma cell disorders (PCDs), including for example the cancer multiple myeloma (MM), who complete the assessment, previously known as a "geriatric assessment," as is outlined in this protocol. Secondary objectives include measuring the response rate to participation of patients in this study, assessing patient satisfaction with the questionnaire, and gathering information that would lend support for future research into these types of assessments in patients with PCDs. Additionally the study offers an optional blood draw to look at a genetic marker of aging called p16INK4a (IRB 15-1899, IRB 15-0244).
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients complete an assessment at baseline and then longitudinally over time which involves a multi-dimensional inter-disciplinary evaluation of a patient's functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, and nutritional status. Patients' medical records are also reviewed.
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| Measure | Description | Time Frame |
|---|---|---|
| Creation of a Registry of Plasma Cell Disorder (PCD) patients | 10 years | |
| Completion of baseline and longitudinal assessments in PCD patients | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Creation of information that would lend support for future PCD research | Including patterns of patient care that would lend support for future research in patients with confirmed PCD's. | 10 years |
| Response rates of assessment in PCD patients and their satisfaction with the assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients have a documented diagnosis of PCD defined as the presence of a monoclonal protein and/or monoclonal plasma cell population.
Examples of PCDs include but are not limited to monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple (active) myeloma; plasma cell leukemia; Castleman's disease; amyloidosis; light and/or heavy chain deposition disease; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes (POEMS) syndrome; and cryoglobulinemia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Mangieri | Contact | (919) 966-4432 | nicholas_mangieri@med.unc.edu | |
| Kendall Conder | Contact | (919) 966-4432 | kendall_conder@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sascha Tuchman, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina Cancer Hospital | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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Blood samples will be banked for future research involving adults with PCDs, specifically examining p16INK4a and other markers to be specified in future, separate, IRB-reviewed protocols as specific research questions are identified.
Done by measuring:
|
| 10 years |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D000686 | Amyloidosis |
| D003449 | Cryoglobulinemia |
| D005871 | Castleman Disease |
| D016878 | POEMS Syndrome |
| D000075122 | Smoldering Multiple Myeloma |
| D007952 | Leukemia, Plasma Cell |
| 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 |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011230 | Precancerous Conditions |
| D006942 | Hypergammaglobulinemia |
| D007938 | Leukemia |
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