Multiple MyelomaMMRDNCT02627261
Multiple Myeloma Minimal Residual Disease
An observational study of Multiple Myeloma, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- blood samples and bone marrow aspirates will be collected
- How many people
- 48 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Nov 2015to 2 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will focus on adult patients with multiple myeloma and who will receive a treatment with high-dose melphalan and autologous bone marrow transplantation
Who may be able to join
- ≥ 18 years
- previously undiagnosed myeloma
- eligible for high dose therapy and bone marrow transplantation
- signed consent
Who cannot join
- ongoing therapy for another neoplasia
- Patients with other hematologic malignancies,
- patients deprived of liberty for administrative or judicial reasons
- previously treated for myeloma
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Huriez
Lille, 59037
Centre Hospitalier Universitaire Hôtel-Dieu de Nantes
Nantes, 44000
Centre Hospitalier Lyon Sud
Pierre Bénité, 69495
About this study
Official title: Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma
Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease
- Conditions
- Multiple Myeloma
- Being tested
- blood samples and bone marrow aspirates will be collected
- Keywords
- residual disease
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples and bone marrow aspirates will be collectedBiological
Serial analysis will be performed at different time point in order to evaluate the presence or absence of residual disease after different treatment steps (before treatment, after induction, after intensification, after consolidation)
| Study group | Role | What they receive |
|---|---|---|
| patients with multiple myeloma | blood samples and bone marrow aspirates will be collected in patients at different time point Receives: Biological: blood samples and bone marrow aspirates will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of residual disease
study the sensitivity of the method of quantification of circulating tumor cells compared to 2 others methods of detection
Measured: Residual disease is assessed up to 18 months after inclusion
Secondary outcomes (3)
kinetic of variation of the residual tumor cells detected by flow cytometry method
% positive cells in bone marrow sample
Measured: 18 months
kinetic of variation of the residual tumor cells detected by new generation sequencing method
% positive in bone marrow sample
Measured: 18 months
kinetic of variation of the circulating tumor cells
number of cells / mL of blood
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start23 Nov 2015
- Primary completion2 Sep 2018
- Study completion2 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627261
- Sponsor's protocol ID
- 69HCL15_0316
- Acronym
- MMRD
- Status last verified
- Sep 2022
- First submitted
- 4 Dec 2015
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02627261
- Acronym / sponsor ID
- MMRD / 69HCL15_0316
- Conditions
- Multiple Myeloma
- Keywords
- residual disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 2 Sep 2018 (actual)
- First posted
- 10 Dec 2015 (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.
Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with multiple myeloma | – | Biological: blood samples and bone marrow aspirates will be collectedblood samples and bone marrow aspirates will be collected in patients at different time point |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will focus on adult patients with multiple myeloma and who will receive a treatment with high-dose melphalan and autologous bone marrow transplantation
Key inclusion criteria (4 listed)
- ≥ 18 years
- previously undiagnosed myeloma
- eligible for high dose therapy and bone marrow transplantation
- signed consent
Key exclusion criteria (4 listed)
- ongoing therapy for another neoplasia
- Patients with other hematologic malignancies,
- patients deprived of liberty for administrative or judicial reasons
- previously treated for myeloma
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 |
|---|---|---|
| blood samples and bone marrow aspirates will be collectedSerial analysis will be performed at different time point in order to evaluate the presence or absence of residual disease after different treatment steps (before treatment, after induction, after intensification, after consolidation) | Biological | patients with multiple myeloma |
Primary outcome
Quantification of residual disease
Time frame: Residual disease is assessed up to 18 months after inclusion
study the sensitivity of the method of quantification of circulating tumor cells compared to 2 others methods of detection
3 secondary outcomes
kinetic of variation of the residual tumor cells detected by flow cytometry method
Time frame: 18 months
kinetic of variation of the residual tumor cells detected by new generation sequencing method
Time frame: 18 months
kinetic of variation of the circulating tumor cells
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Hospices Civils de Lyon at 3 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: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of residual disease (time frame: Residual disease is assessed up to 18 months after inclusion). 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 6 Sep 2022.