Geriatric Assessments in Senior Adults With Multiple Myeloma

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma

Conditions
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Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Questionnaires<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between initial treatment recommendation and baseline questionnaires assessment | 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. | At baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in questionnaires from baseline to 6 months | 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 | Through 6 months of follow-up | 
| Completion of the questionnaires at 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. | Baseline, 3 months, and 6 months |