Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma
65 Years
N/A
Both
Multiple Myeloma
Trial Information
Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma
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.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
Questionnaires assessment
Outcome Description:
Frequencies will be tabulated for categorical variables initial treatment strategy with and without HDT/ASCT. Prevalence of comorbidity and dependencies in Instrumental Activities of Daily Living (IADLs) at baseline in these two groups will be reported with 95% confidence intervals. Univariate analysis will be performed to compare the comorbidity and dependencies in IADLs at baseline in patients whose initial treatment strategy with and without HDT/ASCT. These analyses will be conducted using the χ2 test for proportions and pooled t test for continuous variables. In the planned multivariate analysis, no more than 2 variables will be entered into the multivariate model, given the sample size of 30. Variables significant at a p<0.20 level on univariate analysis will move forward in the multivariate model.
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Tanya Wildes, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
201207060
NCT ID:
NCT01746030
Start Date:
September 2012
Completion Date:
March 2014
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
