Multiple MyelomaMYRACLENCT03807128
MYeloma Resistance And Clonal Evolution
An observational study of Multiple Myeloma, run by Nantes University Hospital at 2 sites in France.
Trial summary
Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. 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?
- Prélèvement sanguin (2*4mL) ou médullaire (2mL) and Data collection through questionnaires
- How many people
- 1,400 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Feb 2019to 11 Feb 2049
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population corresponds to multiple myeloma patients managed in the hematology departments of the University Hospital of Nantes and the CHD of La Roche sur Yon. Recruitment of the hematology departments of the University Hospital of Nantes and CHD of La Roche sur Yon makes it possible to envisage an annual recruitment of 60 new myeloma diagnoses, and an annual number of 80 relapses. These data are estimated from the number of files submitted to the Multidisciplinary Collaborative Meeting (RPN) and the annual inclusion number in clinical trials. This number represents a cohort of about 140 inclusions per year. The average number of visits can be estimated at 1.5 / year per patient.
Who may be able to join
- Patient consulting due to the discovery or recurrence of MM according to international diagnostic criteria (IMWG 2014)
- Patient having consented to participate in the study and his/her biocollection
- Patient affiliated to or benefiting from a social security scheme or similar
Who cannot join
- Minors
- Major under guardianship or curatorship
- Protected persons.
- Pregnant or breast-feeding women
- Persons benefiting from the AME
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
La Roche sur Yon Hospital Departmental
La Roche-sur-Yon, 85000
- Recruiting
Nantes University Hospital
Nantes, 44093
Cyrille TOUZEAU, PU, 02 53 48 24 05, cyrille.touzeau@chu-nantes.fr
About this study
Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.
Read the detailed description
The MYRACLE cohort study aims at including all patients (>18 years old) who are diagnosed with MM in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up until refusal to participate in the study, emigration or death. The MYRACLE follow-up is continuous and collects data on socio-economic status, medical status, MM therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.
- Conditions
- Multiple Myeloma
- Being tested
- Prélèvement sanguin (2*4mL) ou médullaire (2mL), Data collection through questionnaires
- Keywords
- Myeloma, Cohort, Resistance, Quality of life
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prélèvement sanguin (2*4mL) ou médullaire (2mL)Other
Additional blood (2*4mL) or bone marrow (2mL) sample depending on clinical presentation of disease
Data collection through questionnairesOther
Collection of quality of life and occupational exposure data via questionnaires
| Study group | Role | What they receive |
|---|---|---|
| MYRACLE patients | Not described Receives: Other: Prélèvement sanguin (2*4mL) ou médullaire (2mL); Other: Data collection through questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the mechanisms of resistance of myeloma cells.
Number of resistance.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start11 Feb 2019
- Primary completion11 Feb 2034 (estimated)
- Study completion11 Feb 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrille TOUZEAU, PU, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807128
- Sponsor's protocol ID
- RC18_0197
- Other IDs
- IDRCB - ANSM
- Acronym
- MYRACLE
- Status last verified
- Jul 2025
- First submitted
- 26 Sep 2018
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grandclement C, Estoppey C, Dheilly E, Panagopoulou M, Monney T, Dreyfus C, Loyau J, Labanca V, Drake A, De Angelis S, Rubod A, Frei J, Caro LN, Blein S, Martini E, Chimen M, Matthes T, Kaya Z, Edwards CM, Edwards JR, Menoret E, Kervoelen C, Pellat-Deceunynck C, Moreau P, Mbow ML, Srivastava A, Dyson MR, Zhukovsky EA, Perro M, Sammicheli S. Development of ISB 1442, a CD38 and CD47 bispecific biparatopic antibody innate cell modulator for the treatment of multiple myeloma. Nat Commun. 2024 Mar 6;15(1):2054. doi: 10.1038/s41467-024-46310-y.
PubMed 38448430Derrien J, Gastineau S, Frigout A, Giordano N, Cherkaoui M, Gaborit V, Boinon R, Douillard E, Devic M, Magrangeas F, Moreau P, Minvielle S, Touzeau C, Letouze E. Acquired resistance to a GPRC5D-directed T-cell engager in multiple myeloma is mediated by genetic or epigenetic target inactivation. Nat Cancer. 2023 Nov;4(11):1536-1543. doi: 10.1038/s43018-023-00625-9. Epub 2023 Aug 31.
PubMed 37653140
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MYeloma Resistance And Clonal Evolution
- ClinicalTrials.gov ID
- NCT03807128
- Acronym / sponsor ID
- MYRACLE / RC18_0197
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Cohort, Resistance, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 11 Feb 2034 (estimated)
- Study completion
- 11 Feb 2049 (estimated)
- First posted
- 16 Jan 2019 (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.
Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.
Detailed description
The MYRACLE cohort study aims at including all patients (>18 years old) who are diagnosed with MM in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up until refusal to participate in the study, emigration or death. The MYRACLE follow-up is continuous and collects data on socio-economic status, medical status, MM therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MYRACLE patients | – | Other: Prélèvement sanguin (2*4mL) ou médullaire (2mL), Other: Data collection through questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population corresponds to multiple myeloma patients managed in the hematology departments of the University Hospital of Nantes and the CHD of La Roche sur Yon. Recruitment of the hematology departments of the University Hospital of Nantes and CHD of La Roche sur Yon makes it possible to envisage an annual recruitment of 60 new myeloma diagnoses, and an annual number of 80 relapses. These data are estimated from the number of files submitted to the Multidisciplinary Collaborative Meeting (RPN) and the annual inclusion number in clinical trials. This number represents a cohort of about 140 inclusions per year. The average number of visits can be estimated at 1.5 / year per patient.
Key inclusion criteria (3 listed)
- Patient consulting due to the discovery or recurrence of MM according to international diagnostic criteria (IMWG 2014)
- Patient having consented to participate in the study and his/her biocollection
- Patient affiliated to or benefiting from a social security scheme or similar
Key exclusion criteria (5 listed)
- Minors
- Major under guardianship or curatorship
- Protected persons.
- Pregnant or breast-feeding women
- Persons benefiting from the AME
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 |
|---|---|---|
| Prélèvement sanguin (2*4mL) ou médullaire (2mL)Additional blood (2*4mL) or bone marrow (2mL) sample depending on clinical presentation of disease | Other | MYRACLE patients |
| Data collection through questionnairesCollection of quality of life and occupational exposure data via questionnaires | Other | MYRACLE patients |
Primary outcome
Describe the mechanisms of resistance of myeloma cells.
Time frame: 15 years
Number of resistance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 38448430Grandclement C, Estoppey C, Dheilly E, Panagopoulou M, Monney T, Dreyfus C, Loyau J, Labanca V, Drake A, De Angelis S, Rubod A, Frei J, Caro LN, Blein S, Martini E, Chimen M, Matthes T, Kaya Z, Edwards CM, Edwards JR, Menoret E, Kervoelen C, Pellat-Deceunynck C, Moreau P, Mbow ML, Srivastava A, Dyson MR, Zhukovsky EA, Perro M, Sammicheli S. Development of ISB 1442, a CD38 and CD47 bispecific biparatopic antibody innate cell modulator for the treatment of multiple myeloma. Nat Commun. 2024 Mar 6;15(1):2054. doi: 10.1038/s41467-024-46310-y.
- Derived from this study: PubMed 37653140Derrien J, Gastineau S, Frigout A, Giordano N, Cherkaoui M, Gaborit V, Boinon R, Douillard E, Devic M, Magrangeas F, Moreau P, Minvielle S, Touzeau C, Letouze E. Acquired resistance to a GPRC5D-directed T-cell engager in multiple myeloma is mediated by genetic or epigenetic target inactivation. Nat Cancer. 2023 Nov;4(11):1536-1543. doi: 10.1038/s43018-023-00625-9. Epub 2023 Aug 31.
- Individual participant dataSharing planned: Undecided
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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.
Cyrille TOUZEAU, PU principal investigator
Nantes University Hospital
2 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 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrille TOUZEAU, PU (02 40 08 32 71, cyrille.touzeau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the mechanisms of resistance of myeloma cells. (time frame: 15 years). 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 NCT03807128, which also lists 2 linked publications.
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 14 Jul 2025.