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

• Conditions: Multiple Myeloma; Comprehensive Geriatric Assessment
• Interventions: Other: Questionaires

• Registration Number: NCT03122327
• Lead Sponsor: Peking Union Medical College Hospital

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

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-20
• Last Update Submitted: 2017-04-23
• Last Update Posted: 2017-04-25
• Study Start: 2017-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newly diagnosed MM patients	Questionaires	newly diagnosed MM patients who fulfilled the inclusion criteria for this study

Primary Outcome Measures

Name	Time	Method
Current status of cGA in newly diagnosed elderly MM patients	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 Outcome Measures

Name	Time	Method
Association between the baseline cGA parameters and patients' overall survival	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	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