Comprehensive Frailty Assessment

The purpose of this research study is to describe a patients' fitness before and after treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of measuring a patient's current quality of health. With surveys, questionnaires and blood tests, we hope to create a tool that will give a good picture of patients' ability to tolerate treatment. In the future, we hope to devise the best treatment for a patient based on their "fitness".

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Key information

Conditions

Myeloma, Multiple Amyloidosis Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Proteostasis Deficiencies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Hospital East

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with a plasma cell dyscrasia AND/OR any patient receiving a stem cell transplant for a hematologic malignancy at The Ohio State University
at least 18 years of age

Exclusion criteria

Any medical or psychiatric condition that would make it difficult for the patient to comply with study procedures.

Treatment and study plan

Primary outcomes

Change in Comprehensive Frailty Assessment

Time frame: up to 14 months

Responses to the Comprehensive Frailty Assessment will be assessed before and after treatment and changes will be evaluated. In transplant patients, this will be measured one year post transplant and in the non-transplant arm, this will be assessed after the second cycle of treatment.

Secondary outcomes

Time to progression

Time frame: date of enrollment to date of documented clinical progression up to two years post-enrollment

We will assess time to progression for multiple myeloma patients and the relationships of those outcomes to patients' functional, cognitive and psychosocial health.

Other outcomes

Overall survival

Time frame: enrollment to date of death up to two years post-enrollment

We will assess overall survival and the relationship of those measures to patients' functional, cognitive and psychosocial health.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jan 13, 2014
Registry last updated: Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed