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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Jian Li, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03122327
First received: April 18, 2017
Last updated: April 23, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Multiple Myeloma
Comprehensive Geriatric Assessment
Other: Questionaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comprehensive Geriatric Assessment (cGA) in Newly-diagnosed Elderly Multiple Myeloma (MM) Patients: a Multi-center, Prospective, Non-interventional Study.

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Current status of cGA in newly diagnosed elderly MM patients [ Time Frame: 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:
  • Association between the baseline cGA parameters and patients' overall survival [ Time Frame: 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 [ Time Frame: 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


Estimated Enrollment: 200
Anticipated Study Start Date: May 1, 2017
Estimated Study Completion Date: May 1, 2022
Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Newly diagnosed MM patients
newly diagnosed MM patients who fulfilled the inclusion criteria for this study
Other: Questionaires
Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM.

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
  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed Multiple myeloma (MM) patients>=65 years old
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03122327

Contacts
Contact: Jian Li, M.D. +86-18610852525 lijian@pumch.cn

Sponsors and Collaborators
Peking Union Medical College Hospital
  More Information

Responsible Party: Jian Li, Associated professor in hematology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03122327     History of Changes
Other Study ID Numbers: S-K230
Study First Received: April 18, 2017
Last Updated: April 23, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 28, 2017