Multiple Myeloma in Older PatientsMYELOME-PANCT02063113
Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
A study testing Vulnerability and therapeutic changes in older patients with multiple myeloma. in people with Multiple Myeloma in Older Patients, run by Nantes University Hospital at 2 sites in France.
Trial summary
The aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. During the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic… Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Multiple Myeloma in Older Patients
- What is being tested?
- Vulnerability and therapeutic changes in older patients with multiple myeloma.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesFrance
- Study dates
- 19 May 2014to 28 Nov 2018
- Phase
- Interventional
- 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 70 years and older
- Patients referred for a assessment of a newly diagnosed multiple myeloma
- Patients for who the initial therapy proposed is either melphalan-prednisone-thalidomide or melphalan-prednisone-bortezomib or included in a phase 3 trial.
- Patients who provide informed written consent
Who cannot join
- Patients who refuse the study
- Patients who won't have therapy
- Patients can't respond to geriatric assessment because of severe cognitive disorder
- Patients with a legal guardian
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHD Vendée La Roche sur Yon
La Roche-sur-Yon
CHU de Nantes
Nantes, 44000
About this study
The aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. During the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic changes will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.
- Conditions
- Multiple Myeloma in Older Patients
- Being tested
- Vulnerability and therapeutic changes in older patients with multiple myeloma.
- Keywords
- Multiple myeloma,, Older patient,, Treatment,, Geriatric assessment
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vulnerability and therapeutic changes in older patients with multiple myeloma.Other
| Study group | Role | What they receive |
|---|---|---|
| NA/NA | No intervention | Not described Receives: Other: Vulnerability and therapeutic changes in older patients with multiple myeloma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of the events
The primary outcome is either :
- early interruption of treatment
- dose reduction > 20% during treatment
- discontinuous treatment
These outcomes will be measured every 6 months during the 2 years of follow up
Measured: 6 MONTHS
Secondary outcomes (5)
Type of Vulnerability
vulnerability related to toxicities, vulnerability related to multiple myeloma or geriatric vulnerability.
Measured: 6 MONTHS
Therapeutic changes
early interruption of treatment, dose reduction during treatment, discontinuous treatment
Measured: 6 MONTHS
Toxicity during treatment
hematologic toxicity, neurotoxicity, gastrointestinal toxicity, deep vein thrombosis, pulmonary embolism, infections with antibiotic use
Measured: 6 months
Progression to 1 and 2 years
Measured: 1 year/2year
Complete response at 1 and 2 years
Measured: 1 year/2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study start19 May 2014
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Why it stopped: inclusion difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in Older PatientsStudies of the same condition, open and under way.
- More trials run by Nantes University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Komivi AGBETSIVI, DR, Principal investigator, CHD Vendée La Roche sur YonVIGNARD Patricia, Dr, Principal investigator, CH du MansCatherine Cattenoz, Dr, Principal investigator, Rennes University HospitalJean -Richard EVEILLARD, Dr, Principal investigator, CHU de BrestFrançois Puisieux, Pr, Principal investigator, CHU de LilleJean -Yves NIEMIER, Dr, Principal investigator, Central Hospital, Nancy, FranceFrédérique Retornaz, Dr, Principal investigator, CGD de MarseilleVéronique Brunel, Dr, Principal investigator, Hôpital Européen de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063113
- Sponsor's protocol ID
- RC13_0437
- Acronym
- MYELOME-PA
- Status last verified
- May 2023
- First submitted
- 11 Feb 2014
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT02063113
- Acronym / sponsor ID
- MYELOME-PA / RC13_0437
- Conditions
- Multiple Myeloma in Older Patients
- Keywords
- Multiple myeloma,, Older patient,, Treatment,, Geriatric assessment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulty
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 19 May 2014 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 14 Feb 2014 (estimated)
- 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.
The aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. During the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic changes will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NA/NA | No intervention | Other: Vulnerability and therapeutic changes in older patients with multiple myeloma. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged 70 years and older
- Patients referred for a assessment of a newly diagnosed multiple myeloma
- Patients for who the initial therapy proposed is either melphalan-prednisone-thalidomide or melphalan-prednisone-bortezomib or included in a phase 3 trial.
- Patients who provide informed written consent
Key exclusion criteria (4 listed)
- Patients who refuse the study
- Patients who won't have therapy
- Patients can't respond to geriatric assessment because of severe cognitive disorder
- Patients with a legal guardian
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 |
|---|---|---|
| Vulnerability and therapeutic changes in older patients with multiple myeloma. | Other | NA/NA |
Primary outcome
The occurrence of the events
Time frame: 6 MONTHS
The primary outcome is either : * early interruption of treatment * dose reduction > 20% during treatment * discontinuous treatment These outcomes will be measured every 6 months during the 2 years of follow up
5 secondary outcomes
Type of Vulnerability
Time frame: 6 MONTHS
Therapeutic changes
Time frame: 6 MONTHS
Toxicity during treatment
Time frame: 6 months
Progression to 1 and 2 years
Time frame: 1 year/2year
Complete response at 1 and 2 years
Time frame: 1 year/2 years
Results and safety
The study was stopped early (reason given: inclusion difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
Related trials for Multiple Myeloma in Older Patients
Active, not recruitingPhase 1
Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients
Leukemia, Acute, Myelodysplastic Syndromes
RecruitingObservational study
Registry of Older Patients With Cancer
Chronic Myeloproliferative Disorders, Cognitive/Functional Effects
Recruiting
Immune Fitness in Older Patients With Relapsed and Refractory Multiple Myeloma
Myeloma Multiple
RecruitingPhase 2
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
Multiple Myeloma, Cancer
Recruiting
Remote Monitoring With Health-Coaching to Improve Quality of Life in Older Patients With Multiple Myeloma
Multiple Myeloma
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.
Komivi AGBETSIVI, DR principal investigator
CHD Vendée La Roche sur Yon
VIGNARD Patricia, Dr principal investigator
CH du Mans
Catherine Cattenoz, Dr principal investigator
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vulnerability and therapeutic changes in older patients with multiple myeloma. in people with Multiple Myeloma in Older Patients, run by Nantes University Hospital at 2 sites in France.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: inclusion difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of the events (time frame: 6 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2023.