Geriatric Assessments in Senior Adults With Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01746030
First received: December 4, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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
Multiple Myeloma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study of Geriatric Assessments in Senior Adults With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The relationship between initial treatment recommendation and baseline questionnaires assessment [ Time Frame: At baseline visit ] [ Designated as safety issue: No ]
    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:
  • Changes in questionnaires from baseline to 6 months [ Time Frame: Through 6 months of follow-up ] [ Designated as safety issue: No ]
    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

  • Completion of the questionnaires at baseline, 3 months and 6 months. [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Questionnaires
No treatment

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Bone Marrow Transplant Clinic at Siteman Cancer Center

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746030

Contacts
Contact: Tanya Wildes, M.D. 314-362-5654 twildes@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Tanya Wildes, M.D.    314-362-5654    twildes@dom.wustl.edu   
Sub-Investigator: Camille Abboud, M.D.         
Sub-Investigator: Kenneth Carson, M.D.         
Sub-Investigator: Amanda Cashen, M.D.         
Sub-Investigator: John DiPersio, M.D., Ph.D.         
Sub-Investigator: Keith Stockerl-Goldstein, M.D.         
Sub-Investigator: Geoffrey Uy, M.D.         
Sub-Investigator: Ravi Vij, M.D.         
Sub-Investigator: Peter Westervelt, M.D., Ph.D.         
Principal Investigator: Tanya Wildes, M.D.         
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Sascha Tuchman, M.D.    919-668-1011    sascha.tuchman@duke.edu   
Sub-Investigator: Sascha Tuchman, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Tanya Wildes, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01746030     History of Changes
Other Study ID Numbers: 201207060
Study First Received: December 4, 2012
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 11, 2014