cGA in Newly-diagnosed Elderly MM Patients: a Multi-center, Prospective, Non-interventional Study.

Study Overview
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Brief Summary
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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
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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

Official Title
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Comprehensive Geriatric Assessment (cGA) in Newly-diagnosed Elderly Multiple Myeloma (MM) Patients: a Multi-center, Prospective, Non-interventional Study.

Conditions
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Multiple Myeloma, Comprehensive Geriatric Assessment

Intervention / Treatment
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* Other: Questionaires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed MM patients<br>newly diagnosed MM patients who fulfilled the inclusion criteria for this study | Other: Questionaires<br>* Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current status of cGA in newly diagnosed elderly MM patients | 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. | 12 cycles of MM treatment (about 12 months) after the last patient begins treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between the baseline cGA parameters and patients' overall survival | 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 | 5 years after the last patient begins treatment for MM | 
| Association between baseline cGA parameters and patients' progression free survival | 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 | 5 years after the last patient begins treatment for MM |