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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly diagnosed MM patients | newly diagnosed MM patients who fulfilled the inclusion criteria for this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionaires | Other | Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Newly diagnosed Multiple myeloma (MM) patients>=65 years old
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Li, M.D. | Contact | +86-18610852525 | lijian@pumch.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34673897 | Derived | Yao Y, Sui WW, Liao AJ, Wang W, Chen LJ, Chu XX, Bao L, Cen XN, Fu R, Liu H, Sun CY, Jin FY, Yan H, Wang LQ, Yuan CL, Gao GX, Gao D, Zhang JQ, He JX, Hu JD, Ma LM, Zhang L, Zhou DB, Zou DH, Li J. Comprehensive geriatric assessment in newly diagnosed older myeloma patients: a multicentre, prospective, non-interventional study. Age Ageing. 2022 Jan 6;51(1):afab211. doi: 10.1093/ageing/afab211. |
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There is no plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |