Comprehensive Geriatric Assessment (cGA) in Newly-diagnosed Elderly Multiple Myeloma (MM) Patients: a Multi-center, Prospective, Non-interventional Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 200
- Primary Endpoint
- Current status of cGA in newly diagnosed elderly MM patients
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a multi-center, prospective, non-interventional study. Eligible newly diagnosed elderly multiple myeloma (MM) patients will receive comprehensive geriatric assessment (cGA) including ECOG scale, questionaires of 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). Patients will get standard care for MM and receive the above assessments at baseline and after cycle 1, 4 and 12 for treating MM.Follow-up information and survival data of these MM patients would be collected. We would evaluate the cGA status of these newly diagnosed elderly MM patients and investigate the association of cGA parameters with patient's survival.
Detailed Description
Baseline: ECOG, ADL, IADL, MNA-SF, GDS, MMSE, SF-36 and CCI; After cycle 1: ECOG,ADL,IADL,GDS and SF-36 After cycle 4: ECOG,ADL,IADL,GDS, MNA-SF and SF-36 After cycle 12: ECOG,ADL,IADL,GDS, MNA-SF and SF-36
Investigators
Jian Li
Associated professor in hematology
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •age\>=65 years old;
- •newly diagnosed and untreated MM patients;
- •able to provide informed consent
Exclusion Criteria
- •refused to participate;
- •with concomitant amyloidosis;
- •smoldering MM.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Association between the baseline cGA parameters and patients' overall survival(5 years after the last patient begins treatment for MM)
- Association between baseline cGA parameters and patients' progression free survival(5 years after the last patient begins treatment for MM)