Multiple MyelomaIMMUNO-MYELONCT04872023
Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint Expression
A study testing Blood and bone marrow sampling in people with Multiple Myeloma, run by Rennes University Hospital at 1 site in France.
Trial summary
The myeloma microenvironment is the target of many drugs in development, and it is unclear how they can be combined with reference treatments such as lenalidomide. This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow… 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 and bone marrow sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2021to 27 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with newly diagnosed multiple myeloma;
- Patient not eligible for intensive treatment;
- Patient for whom first-line treatment with Lenalidomide-Dexamethasone will be initiated;
- Patient accepting the performance of an additional myelogram at the end of the 1st treatment cycle.
- Patient aged 18 years or older;
- Patient who has given free, informed and written consent;
- Patient affiliated to a social security scheme
- For women of childbearing age, use of effective contraception
Who cannot join
- Patient with relapsed multiple myeloma;
- Patient eligible for intensive treatment;
- Patient for whom chemotherapy involves treatment other than Lenalidomide-Dexamethasone;
- Patient with a contraindication to lenalidomide treatment
- Pregnant or breastfeeding woman;
- Person subject to legal protection (safeguard of justice, curatorship,guardianship) or person deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint
The myeloma microenvironment is the target of many drugs in development, and it is unclear how they can be combined with reference treatments such as lenalidomide. This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.
This study will provide rational guidance for future combination therapies with lenalidomide.
Read the detailed description
With the significant increase in the number of therapeutic combinations targeting the tumour microenvironment, it is crucial to better understand the effect of reference myeloma treatments on the different immune populations present in the tumour in order to rationally optimise the combination with new strategies under development. In addition, the identification of biomarkers in the circulating blood that can predict/monitor the impact of new therapies on the immune response is a major challenge.
This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.
- Conditions
- Multiple Myeloma
- Being tested
- Blood and bone marrow sampling
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and bone marrow samplingOther
Blood and bone marrow sampling
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | All patients will have a extra blood sampling before first cycle of treatment and after one cycle. They also have an extra bone marrow sampling after the first cycle of treatment Receives: Other: Blood and bone marrow sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HLA-DR on medullary T-lymphocytes
Changed expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.
Measured: 1 month
Secondary outcomes (1)
Activation status of biological markers
Presence of active protein markers and immune checkpoints by medullary immune cell subpopulations.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start29 Jul 2021
- Primary completion13 Jun 2022
- Study completion27 Jan 2023
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 Rennes 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872023
- Sponsor's protocol ID
- 35RC17_8825_IMMUNOMYELO
- Acronym
- IMMUNO-MYELO
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint
- ClinicalTrials.gov ID
- NCT04872023
- Acronym / sponsor ID
- IMMUNO-MYELO / 35RC17_8825_IMMUNOMYELO
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 4 May 2021 (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.
The myeloma microenvironment is the target of many drugs in development, and it is unclear how they can be combined with reference treatments such as lenalidomide. This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.
This study will provide rational guidance for future combination therapies with lenalidomide.
Detailed description
With the significant increase in the number of therapeutic combinations targeting the tumour microenvironment, it is crucial to better understand the effect of reference myeloma treatments on the different immune populations present in the tumour in order to rationally optimise the combination with new strategies under development. In addition, the identification of biomarkers in the circulating blood that can predict/monitor the impact of new therapies on the immune response is a major challenge.
This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Blood and bone marrow samplingAll patients will have a extra blood sampling before first cycle of treatment and after one cycle. They also have an extra bone marrow sampling after the first cycle of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with newly diagnosed multiple myeloma;
- Patient not eligible for intensive treatment;
- Patient for whom first-line treatment with Lenalidomide-Dexamethasone will be initiated;
- Patient accepting the performance of an additional myelogram at the end of the 1st treatment cycle.
- Patient aged 18 years or older;
Key exclusion criteria (6 listed)
- Patient with relapsed multiple myeloma;
- Patient eligible for intensive treatment;
- Patient for whom chemotherapy involves treatment other than Lenalidomide-Dexamethasone;
- Patient with a contraindication to lenalidomide treatment
- Pregnant or breastfeeding woman;
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 and bone marrow samplingBlood and bone marrow sampling | Other | Patients |
Primary outcome
Rate of HLA-DR on medullary T-lymphocytes
Time frame: 1 month
Changed expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.
1 secondary outcome
Activation status of biological markers
Time frame: 1 month
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 3 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and bone marrow sampling in people with Multiple Myeloma, run by Rennes University Hospital at 1 site 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 8 inclusion and 6 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of HLA-DR on medullary T-lymphocytes (time frame: 1 month). 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 3 Feb 2023.