Multiple MyelomaCARE-HemeNCT05556928
Cancer and Aging Resilience Evaluation in Older Adults With Hematologic Malignancies: The CARE-Heme Registry
An observational study of Multiple Myeloma and Amyloidosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Multiple Myeloma, Amyloidosis, Plasma Cell Leukemia
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: Patients ≥50 years of age with a diagnosis of any Hematologic Malignancy having an appointment at any participating UAB entity.
Who may be able to join
- Patients are ≥50 years of age.
- Patients have a biopsy proven diagnosis of Hematologic Malignancy (Multiple Myeloma, AL Amyloidosis, Waldenstrom's Macrogloblunemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic syndromes, Myeloproliferative Neoplasm, Acute/Chronic Myeloid Leukemia, Acute/Chronic Lymphoid Leukemia).
- Patients have appointments at UAB including if they are an inpatient or other clinic locations.
Who cannot join
- Individuals who are <50 years old.
- Patients who do not read and/or speak English will not be eligible for this study as many of the questionnaires are not validated in other languages. No exclusions will be made based on gender, ethnicity or race.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35294
Smith Giri, Dr., (205) 638-2120, CAREheme@peds.uab.edu
About this study
The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.
Read the detailed description
All participants will be invited to participate in a patient reported geriatric assessment questionnaire as well as an objective physical function testing. This includes the Short Physical Performance Battery (SPPB) that evaluates lower extremity performance and muscle strength assessment via hand grip dynamometer. Participants will also complete a 12 item modified version of PRO-CTCAE. This will be administered by trained research staff at the time of study enrollment. Repeat CARE instruments (Follow-up GA questionnaire and Physical Function test) will be administered after the baseline visit to measure changes in patient reported outcomes at 3 months, 6 months, and one year. A one-time blood or saliva sample will be requested and obtained at baseline or a follow-up visit.
- Conditions
- Multiple Myeloma, Amyloidosis, Plasma Cell Leukemia
- Medical subject headings
- Multiple Myeloma, Amyloidosis, Leukemia, Plasma Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Create the CARE-Heme Registry
To establish and maintain a well-annotated registry (to be called the 'CARE-Heme' Registry) of adults ≥50 years of age with a hematologic malignancy to improve our understanding of this vulnerable population.
Measured: 5 years
Secondary outcomes (1)
To administer a patient reported geriatric assessment and a brief objective physical assessment.
To measure the proportion of patients with overall and domain-specific geriatric impairments, the proportion of patients with Myopenia, and the proportion of patients with frailty.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start21 Jul 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mohamed Sharafeldin, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556928
- Sponsor's protocol ID
- IRB-300005372
- Acronym
- CARE-Heme
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No