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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.
Given the growing elderly multiple myeloma population, the increase in therapeutic possibilities and the importance of geriatric screening, this study wants:
Geriatric scoring will be performed in 3 different ways:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline |
| Change in geriatric categorization (fit versus frail) by CGA from baseline to 3 months of anti-myeloma therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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200 newly diagnosed elderly Multiple Myeloma patients
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| Name | Affiliation | Role |
|---|---|---|
| Michel Delforge, MD PhD | UZ Leuven Gasthuisberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Antwerpen | Antwerp | 2060 | Belgium | |||
| Centre Hospitalier EpiCURA |
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| 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. |
| Progression free survival | 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 | 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 | 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) | 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 | 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 | 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 | 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. |
| Baudour |
| 7331 |
| Belgium |
| Imelda Ziekenhuis | Bonheiden | 2820 | Belgium |
| AZ Klina | Brasschaat | 2930 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| GHdC Charlerloi | Charleroi | 6000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Ziekenhuis Oost-Limburg (ZOL) | Genk | 3600 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Hôpital de Jolimont | Haine-Saint-Paul | 7100 | Belgium |
| Jan Yperman Ziekenhuis | Ieper | 8900 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU Tivoli | La Louvière | 7100 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Heilig-Hartziekenhuis Lier | Lier | 2500 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| AZ Nikolaas | Sint-Niklaas | 9100 | Belgium |
| CHU Dinant-Mont-Godinne | Yvoir | 5330 | Belgium |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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