cGA in Newly-diagnosed Elderly MM Patients: a Multi-center, Prospective, Non-interventional Study.
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|ClinicalTrials.gov Identifier: NCT03122327|
Recruitment Status : Not yet recruiting
First Posted : April 20, 2017
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment|
|Multiple Myeloma Comprehensive Geriatric Assessment||Other: Questionaires|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Comprehensive Geriatric Assessment (cGA) in Newly-diagnosed Elderly Multiple Myeloma (MM) Patients: a Multi-center, Prospective, Non-interventional Study.|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2022|
Newly diagnosed MM patients
newly diagnosed MM patients who fulfilled the inclusion criteria for this study
Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM.
- Current status of cGA in newly diagnosed elderly MM patients [ Time Frame: 12 cycles of MM treatment (about 12 months) after the last patient begins treatment ]Description of the cGA (comprehensive geriatric assessment) status of the target population which is currently not known in China. The cGA parameters to be described include baseline ECOG, ADL（activities of daily living), IADL(instrumental ADL),MNA-SF(mini-nutritional assessment), GDS(geriatric depression scale), MMSE(mini-mental state examination), SF-36 and CCI (charlson comorbidity index) which would be carried out by trained physicians. The physicians would receive standard training from geriatricians of Peking Union Medical College Hospital. Moreover, as the treatment for MM (multiple myeloma) patients continues, re-evaluation of the cGA parameters would be done. The status of ECOG, ADL, IADL, GDS, SF-36 would be re-evaluated after cycle 1, 4, 12 of MM treatment. And MNA-SF scale would be re-assessed after cycle 4 and 12 of MM treatment. A description of the changes of the above scales would also be recorded for these MM patients.
- Association between the baseline cGA parameters and patients' overall survival [ Time Frame: 5 years after the last patient begins treatment for MM ]To evaluate the association of the baseline cGA parameters (including ECOG, ADL, IADL,MNA-SF, GDS, MMSE, SF-36 and CCI ) and patient's overall survival
- Association between baseline cGA parameters and patients' progression free survival [ Time Frame: 5 years after the last patient begins treatment for MM ]To evaluate the association of cGA parameters (including ECOG, ADL, IADL,MNA-SF, GDS, MMSE, SF-36 and CCI ) and patient's progression free survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122327
|Contact: Jian Li, M.D.||+firstname.lastname@example.org|