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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma|
- The relationship between initial treatment recommendation and baseline questionnaires assessment [ Time Frame: At baseline visit ] [ Designated as safety issue: No ]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.
- Changes in questionnaires from baseline to 6 months [ Time Frame: Through 6 months of follow-up ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746030
|Contact: Tanya Wildes, M.D.||firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Tanya Wildes, M.D. 314-362-5654 email@example.com|
|Sub-Investigator: Camille Abboud, M.D.|
|Sub-Investigator: Kenneth Carson, M.D.|
|Sub-Investigator: Amanda Cashen, M.D.|
|Sub-Investigator: John DiPersio, M.D., Ph.D.|
|Sub-Investigator: Keith Stockerl-Goldstein, M.D.|
|Sub-Investigator: Geoffrey Uy, M.D.|
|Sub-Investigator: Ravi Vij, M.D.|
|Sub-Investigator: Peter Westervelt, M.D., Ph.D.|
|Principal Investigator: Tanya Wildes, M.D.|
|United States, North Carolina|
|Duke University||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Sascha Tuchman, M.D. 919-668-1011 firstname.lastname@example.org|
|Sub-Investigator: Sascha Tuchman, M.D.|
|Principal Investigator:||Tanya Wildes, M.D.||Washington University School of Medicine|