Geriatric Assessments in Senior Adults With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746030
• Other study ID #: 201207060
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: November 19, 2015
• Start date: September 2012
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine