Multiple MyelomaNCT03122327
cGA in Newly-diagnosed Elderly MM Patients: a Multi-center, Prospective, Non-interventional Study.
An observational study of Multiple Myeloma and Comprehensive Geriatric Assessment, run by Peking Union Medical College Hospital.
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)… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma, Comprehensive Geriatric Assessment
- What is being tested?
- Questionaires
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Newly diagnosed Multiple myeloma (MM) patients>=65 years old
Who may be able to join
- age>=65 years old;
- newly diagnosed and untreated MM patients;
- able to provide informed consent
Who cannot join
- refused to participate;
- with concomitant amyloidosis;
- smoldering MM.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comprehensive Geriatric Assessment (cGA) in Newly-diagnosed Elderly Multiple Myeloma (MM) Patients: a Multi-center, Prospective, Non-interventional Study.
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.
Read the 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
- Being tested
- Questionaires
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionairesOther
Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed MM patients | newly diagnosed MM patients who fulfilled the inclusion criteria for this study Receives: Other: Questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 5 years after the last patient begins treatment for MM
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
Measured: 5 years after the last patient begins treatment for MM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122327
- Sponsor's protocol ID
- S-K230
- Status last verified
- Apr 2017
- First submitted
- 18 Apr 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Publications
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.
PubMed 34673897
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment (cGA) in Newly-diagnosed Elderly Multiple Myeloma (MM) Patients: a Multi-center, Prospective, Non-interventional Study.
- ClinicalTrials.gov ID
- NCT03122327
- Acronym / sponsor ID
- S-K230
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed MM patients | – | Other: Questionairesnewly diagnosed MM patients who fulfilled the inclusion criteria for this study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Newly diagnosed Multiple myeloma (MM) patients>=65 years old
Key inclusion criteria (3 listed)
- age>=65 years old;
- newly diagnosed and untreated MM patients;
- able to provide informed consent
Key exclusion criteria (3 listed)
- refused to participate;
- with concomitant amyloidosis;
- smoldering MM.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionairesQuestionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM. | Other | Newly diagnosed MM patients |
Primary outcome
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.
2 secondary outcomes
Association between the baseline cGA parameters and patients' overall survival
Time frame: 5 years after the last patient begins treatment for MM
Association between baseline cGA parameters and patients' progression free survival
Time frame: 5 years after the last patient begins treatment for MM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 34673897Yao 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.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Comprehensive Geriatric Assessment, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Li, M.D. (+86-18610852525, lijian@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03122327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.