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CompletedNCT01746030Updated Nov 20, 2015

Geriatric Assessments in Senior Adults With Multiple Myeloma

An observational study in Multiple Myeloma, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-11-20.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
42
Ages
65 Years and older
Sex
All
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Study 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.

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Conditions studied

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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 42 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Bone Marrow Transplant Clinic at Siteman Cancer Center

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

Exclusion Criteria:

  • Patient must not have a diagnosis of smoldering myeloma.
  • Patient must not have concomitant amyloidosis.
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Study design

Time perspective
Prospective
Enrollment
42 participants (actual)
Patient registry
No

Groups and cohorts

  • Questionnaires

    No treatment

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline visit

Secondary outcomes

  1. 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

    Time frame: Through 6 months of follow-up

  2. 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.

    Time frame: Baseline, 3 months, and 6 months

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Study locations

1 site
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01746030
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Dec 10, 2012
Start date
Sep 2012
Primary completion
Dec 2014
Completion
Jul 2015
Last update
Nov 20, 2015

Study contacts

Tanya Wildes, M.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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