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Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma


N/A
65 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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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