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Completed

NCT Number: NCT02918695

Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients

The purpose of this study is to compare clinical judgment and comprehensive geriatric assessment as screening tools for optimization of treatment for newly diagnosed elderly multiple myeloma patients.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ZNA Antwerpen, Antwerp, Belgium

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About this study

Given the growing elderly multiple myeloma population, the increase in therapeutic possibilities and the importance of geriatric screening, this study wants:

  • to compare clinical judgment with standardized geriatric screening approaches (G8, CGA and IMWG score) in newly diagnosed elderly myeloma patients and to evaluate their influence on the detection of geriatric problems and on the choice of the anti-myeloma treatment
  • to evaluate how geriatric scoring and the subsequent treatment choice influences the therapeutic efficacy and toxicities

Geriatric scoring will be performed in 3 different ways:

  • by clinical judgment performed by the treating physician
  • by validated scoring systems independently performed by a trained nurse/ health care worker. Initial scoring will be done by the G8 score. If an abnormal G8 score is present (<= 14), CGA will be performed.
  • based on the CGA parameters, the Palumbo/IMWG geriatric score will be calculated

Results obtained by physician-based assessment and by geriatric assessment will be compared before treatment initiation. If, and to what extent the knowledge of the GA influences the therapeutic decision of the treating physician will be registered. In addition, we will register which geriatric problems diagnosed by the CGA assessment were already known or unknown by the treating physician. After three months of treatment and at the time of disease progression, geriatric assessment will be repeated in order to judge the evolution (disappearance, improvement, worsening) of the scored parameters, or the emergence of new geriatric symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed multiple myeloma
  • age => 70 years
  • no previous anti-myeloma treatment except for local radiotherapy or short course (max 4 days) of high-dose dexamethasone
  • signed informed consent
  • patients included in an interventional therapeutic trial are eligible

Exclusion criteria

  • previous systemic anti-myeloma treatment
  • severe mental or cognitive disorder precluding geriatric assessment
  • patient refusal to sign informed consent

Treatment and study plan

Primary outcomes

  1. Comparison of the geriatric categorization (fit versus frail) by standard clinical assessment versus by geriatric scoring.

    Time frame: At baseline

    Comparison of geriatric categorization by standard clinical assessment (fit versus frail ) versus by geriatric scoring ( G8 score, CGA (Comprehensive Geriatric Assessment) and IMWG score will result in fit or frail) will be presented in proportion of agreement (accuracy, specificity, sensitivity, positive predictive value, negative predictive value).

Secondary outcomes

  1. Comparison of the geriatric categorization (fit versus frail) by CGA versus by IMWG scoring

    Time frame: At baseline

    The results will be presented in terms of accuracy, specificity, sensitivity, positive predictive value, negative predictive value.

  2. Change in geriatric categorization (fit versus frail) by CGA from baseline to 3 months of anti-myeloma therapy.

    Time frame: after 3 months of anti-myeloma treatment

  3. Change in geriatric categorization (fit versus frail) by CGA from baseline to time of first relapse of multiple myeloma

    Time frame: At first relapse of multiple myeloma, defined according to IMWG criteria (ref. Durie et al. Leukemia 2006)

  4. Description of geriatric problems detected by CGA ( unknown items assessed by validated CGA scoring tool)(ref. Kenis et al. An of Onc 2013;24:1306)

    Time frame: At baseline

  5. Response rate

    Time frame: Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

  6. Progression free survival

    Time frame: Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

  7. Overall survival

    Time frame: Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

  8. Treatment-related deaths

    Time frame: Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

  9. Grade 3 and 4 non-hematological and grade 4 hematological adverse events (according to CTCAE 4.0)

    Time frame: Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

  10. Treatment discontinuation

    Time frame: Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

  11. Dose reductions of anti-myeloma treatment

    Time frame: Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

  12. Description of the causes for dose-reduction and/or treatment discontinuation

    Time frame: Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Comparison of Different Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients, and Assessment of Therapeutic Efficacy and Toxicity in Fit and Frail Patients. A Multicenter Observational Belgian Study.

Acronym: COMPASS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 29, 2016
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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