Geriatric Assessments in Senior Adults With Multiple Myeloma

This study will evaluate the prevalence of geriatric syndromes in older adults with multiple myeloma, examine relationships between baseline geriatrics syndromes and initial treatment selection, and examine risk of functional decline.

Relationship between baseline geriatric questionnaires and initial treatment selection in older adults with newly diagnosed multiple myeloma.

Feasibility of subjects completing the CARG geriatric assessments at baseline, 3 months and 6 months.

Comorbidities or dependence in IADLs at baseline predict decline in functional status at 6 months of follow-up in older adults with newly diagnosed multiple myeloma.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient must have a diagnosis of multiple myeloma by IMWF criteria: diagnosis must have occurred within 3 months of study enrollment.
Patient must be ≥ 65 years of age.
Patient's life expectancy must be ≥ 6 months.
Patient must be willing to complete follow-up assessments.
Patient must be able to understand and willing to sign a written informed consent document.

Exclusion criteria

Patient must not have a diagnosis of smoldering myeloma.
Patient must not have concomitant amyloidosis.

Treatment and study plan

Primary outcomes

The relationship between initial treatment recommendation and baseline questionnaires assessment

Time frame: At baseline visit

The physician caring for the patient will be asked to identify his/her initial treatment recommendations. This includes whether the patient is, in his/her assessment, a candidate for high dose therapy and autologous stem cell transplantation. It will also include whether a 2-drug or 3-drug regimen is recommended initially.

Secondary outcomes

Changes in questionnaires from baseline to 6 months

Time frame: Through 6 months of follow-up

Logistic regression analyses, adjusted odds ratios (ORs) based on model will be given with 95% CIs. All analyses will use two-tailed significance levels of 0.05 and will be conducted with statistical software SAS 9.2. Geriatric assessment variables will be analyzed as continuous or ordinal variables as indicated. Candidate variables will include: demographic data (including age, gender, race), disease data (stage, cytogenetic abnormalities), or geriatric assessment variables (comorbidity, functional status, physical function, psychological state, nutrition, social support and social activity). Analyses will be performed for the outcomes of treatment selection (transplant vs non-transplant) and increased dependence in IADLs
Completion of the questionnaires at baseline, 3 months and 6 months.

Time frame: Baseline, 3 months, and 6 months

Feasibility of subjects completing questionnaires is defined as 90% of consenting subjects completing the baseline geriatric assessment battery, and 80% of consenting subjects completing follow-up assessments at 3 and 6 months.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Dec 10, 2012
Registry last updated: Nov 20, 2015

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