NCT02918695

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 7, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

3.8 years

First QC Date

September 13, 2016

Last Update Submit

May 3, 2021

Conditions

Multiple MyelomaHematologic Diseases

Keywords

Geriatric assessmentFit and frail elderlyGeriatric oncology

Outcome Measures

Primary Outcomes (1)

  • 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).

    At baseline

Secondary Outcomes (12)

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

    At baseline

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

    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

    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)

    At baseline

  • Response rate

    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 more secondary outcomes

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

200 newly diagnosed elderly Multiple Myeloma patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

ZNA Antwerpen

Antwerp, 2060, Belgium

Location

Centre Hospitalier EpiCURA

Baudour, 7331, Belgium

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

AZ Klina

Brasschaat, 2930, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

GHdC Charlerloi

Charleroi, 6000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Ziekenhuis Oost-Limburg (ZOL)

Genk, 3600, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Hôpital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Jan Yperman Ziekenhuis

Ieper, 8900, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

CHU Tivoli

La Louvière, 7100, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Heilig-Hartziekenhuis Lier

Lier, 2500, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

Location

CHU Dinant-Mont-Godinne

Yvoir, 5330, Belgium

Location

MeSH Terms

Conditions

Multiple MyelomaHematologic Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Michel Delforge, MD PhD

    UZ Leuven Gasthuisberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 29, 2016

Study Start

April 7, 2017

Primary Completion

February 2, 2021

Study Completion

February 2, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Locations

BE(20)