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Geriatric Assessments in Senior Adults With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01746030
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : November 20, 2015
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease
Multiple Myeloma

Study Type : Observational
Actual Enrollment : 42 participants
Time Perspective: Prospective
Official Title: Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma
Study Start Date : September 2012
Primary Completion Date : December 2014
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

No treatment

Primary Outcome Measures :
  1. The relationship between initial treatment recommendation and baseline questionnaires assessment [ Time Frame: At baseline visit ]
    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.

Secondary Outcome Measures :
  1. Changes in questionnaires from baseline to 6 months [ Time Frame: Through 6 months of follow-up ]
    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

  2. Completion of the questionnaires at baseline, 3 months and 6 months. [ Time Frame: 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.

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746030

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Tanya Wildes, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01746030     History of Changes
Other Study ID Numbers: 201207060
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases