Comprehensive Frailty Assessment

NCT02033928 | Completed

• 1 other identifier: OSU-13135
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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".

Conditions

Myeloma, Multiple; Paraproteinemias; Hematologic Neoplasms

Keywords

Myeloma; MGUS (monoclonal gammopathy of undetermined significance); amyloidosis; stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Change in Comprehensive Frailty Assessment

  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.

  up to 14 months

Secondary Outcomes (1)

• Time to progression

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

Other Outcomes (1)

• Overall survival

  enrollment to date of death up to two years post-enrollment

Study Arms (2)

Arm I: Transplant patients

Arm II: Plasma cell dyscrasia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at The Ohio State University with a plamsa cell dyscrasia and/or any patient receiving a blood or marrow transplant at Ohio State will be considered for this study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University Hospital East

Columbus, Ohio, 43205, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Multiple Myeloma; Paraproteinemias; Hematologic Neoplasms; Neoplasms, Plasma Cell; Monoclonal Gammopathy of Undetermined Significance; Amyloidosis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Hypergammaglobulinemia; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ashley Rosko, MD

  The Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 13, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

US (1)