Multiple MyelomaCOMPASSNCT02918695
Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients
An observational study of Multiple Myeloma and Hematologic Diseases, run by Universitaire Ziekenhuizen KU Leuven at 20 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Multiple Myeloma, Hematologic Diseases
- How many people
- 200 participants
- Where
- 20 sitesBelgium
- Study dates
- 7 Apr 2017to 2 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 200 newly diagnosed elderly Multiple Myeloma patients
Who may be able to join
- 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
Who cannot join
- previous systemic anti-myeloma treatment
- severe mental or cognitive disorder precluding geriatric assessment
- patient refusal to sign informed consent
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Belgium20 sites
ZNA Antwerpen
Antwerp, 2060
Centre Hospitalier EpiCURA
Baudour, 7331
Imelda Ziekenhuis
Bonheiden, 2820
AZ Klina
Brasschaat, 2930
Institut Jules Bordet
Brussels, 1000
UZ Brussel
Brussels, 1090
Cliniques Universitaires Saint-Luc
Brussels, 1200
GHdC Charlerloi
Charleroi, 6000
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Ziekenhuis Oost-Limburg (ZOL)
Genk, 3600
UZ Gent
Ghent, 9000
Hôpital de Jolimont
Haine-Saint-Paul, 7100
Jan Yperman Ziekenhuis
Ieper, 8900
AZ Groeninge
Kortrijk, 8500
CHU Tivoli
La Louvière, 7100
UZ Leuven Gasthuisberg
Leuven, 3000
CHU de Liège
Liège, 4000
Heilig-Hartziekenhuis Lier
Lier, 2500
AZ Nikolaas
Sint-Niklaas, 9100
CHU Dinant-Mont-Godinne
Yvoir, 5330
About this study
Official 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.
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma, Hematologic Diseases
- Keywords
- Geriatric assessment, Fit and frail elderly, Geriatric oncology
- Medical subject headings
- Multiple Myeloma, Hematologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the geriatric categorization (fit versus frail) by standard clinical assessment versus by geriatric scoring.
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).
Measured: At baseline
Secondary outcomes (12)
Comparison of the geriatric categorization (fit versus frail) by CGA versus by IMWG scoring
The results will be presented in terms of accuracy, specificity, sensitivity, positive predictive value, negative predictive value.
Measured: At baseline
Change in geriatric categorization (fit versus frail) by CGA from baseline to 3 months of anti-myeloma therapy.
Measured: after 3 months of anti-myeloma treatment
Change in geriatric categorization (fit versus frail) by CGA from baseline to time of first relapse of multiple myeloma
Measured: At first relapse of multiple myeloma, defined according to IMWG criteria (ref. Durie et al. Leukemia 2006)
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)
Measured: At baseline
Response rate
Measured: 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.
Progression free survival
Measured: 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.
Overall survival
Measured: 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.
Treatment-related deaths
Measured: 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.
Grade 3 and 4 non-hematological and grade 4 hematological adverse events (according to CTCAE 4.0)
Measured: 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.
Treatment discontinuation
Measured: 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.
Dose reductions of anti-myeloma treatment
Measured: 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.
Description of the causes for dose-reduction and/or treatment discontinuation
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start7 Apr 2017
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Delforge, MD PhD, Principal investigator, UZ Leuven Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918695
- Sponsor's protocol ID
- NA-NI-MM-PI-006760
- Acronym
- COMPASS
- Status last verified
- May 2021
- First submitted
- 13 Sep 2016
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02918695
- Acronym / sponsor ID
- COMPASS / NA-NI-MM-PI-006760
- Conditions
- Multiple Myeloma, Hematologic Diseases
- Keywords
- Geriatric assessment, Fit and frail elderly, Geriatric oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 200 newly diagnosed elderly Multiple Myeloma patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- previous systemic anti-myeloma treatment
- severe mental or cognitive disorder precluding geriatric assessment
- patient refusal to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
12 secondary outcomes
Comparison of the geriatric categorization (fit versus frail) by CGA versus by IMWG scoring
Time frame: At baseline
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
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)
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
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Delforge, MD PhD principal investigator
UZ Leuven Gasthuisberg
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Hematologic Diseases, run by Universitaire Ziekenhuizen KU Leuven at 20 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the geriatric categorization (fit versus frail) by standard clinical assessment versus by geriatric scoring. (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.