Registry for Adults With Plasma Cell Disorders (PCD's)

RECRUITING

I'm interested ...!!

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).

Conditions:

🦠 Multiple Myeloma 🦠 Amyloidosis 🦠 Cryoglobulinemia 🦠 Castleman's Disease 🦠 Light Chain Deposition Disease 🦠 Heavy Chain Deposition Disease 🦠 Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes 🦠 Smoldering Multiple Myeloma 🦠 Plasma Cell Leukemia

More conditions available...

🗓️ Study Start (Actual) 9 February 2018

🗓️ Primary Completion (Estimated) February 2028

✅ Study Completion (Estimated) February 2029

👥 Enrollment (Estimated) 2000

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Chapel Hill, North Carolina, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Patients have an outpatient appointment or are hospitalized inpatient at UNC Cancer Hospitals, or affiliated clinic settings or participating sites for the evaluation and management of a PCD.
* 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.
* Age ≥18 years.
* Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points.
* Must be able to read and speak English.

Exclusion Criteria:

* Physical or psychiatric/behavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study.
* There are no imaging or lab studies required to determine eligibility.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 22 October 2018
First Submitted that Met QC Criteria 22 October 2018
First Posted 24 October 2018

Study Record Updates

Last Update Submitted that Met QC Criteria 20 March 2024
Last Update Posted 22 March 2024
Last Verified March 2024