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

NCT03122327 | Unknown

• 1 other identifier: S-K230
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma; Comprehensive Geriatric Assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Newly diagnosed MM patients

newly diagnosed MM patients who fulfilled the inclusion criteria for this study

Other: Questionaires

Interventions

Questionaires OTHER

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

Newly diagnosed MM patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed Multiple myeloma (MM) patients\>=65 years old

You may qualify if:

• age\>=65 years old;
• newly diagnosed and untreated MM patients;
• able to provide informed consent

You may not qualify if:

• refused to participate;
• with concomitant amyloidosis;
• smoldering MM.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related Publications (1)

• 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.

  PMID: 34673897 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jian Li, M.D.

CONTACT

+86-18610852525; lijian@pumch.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor in hematology

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 20, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2022
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share