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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03122327
• Other study ID #: S-K230
• Status: Not yet recruiting
• Phase: N/A
• First received: April 18, 2017
• Last updated: April 23, 2017
• Start date: May 1, 2017
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2017
• Source: Peking Union Medical College Hospital
• Contact: Jian Li, M.D.
• Phone: +86-18610852525
• Email: lijian[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Comprehensive Geriatric Assessment
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Questionaires
Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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