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RecruitingNCT03807128MYRACLEUpdated Jul 14, 2025

MYeloma Resistance And Clonal Evolution

An observational study in Multiple Myeloma, sponsored by Nantes University Hospital. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-14.

Sponsored by Nantes University Hospital · Observational

From the registry’s dates

  • Started Feb 2019; still recruiting 7 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,400
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Myeloma
  • Cohort
  • Resistance
  • Quality of life
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 1,400 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Minors
  • Major under guardianship or curatorship
  • Protected persons.
  • Pregnant or breast-feeding women
  • Persons benefiting from the AME
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,400 participants (estimated)
Patient registry
No

Groups and cohorts

  • MYRACLE patients

    Other: Prélèvement sanguin (2*4mL) ou médullaire (2mL) · Other: Data collection through questionnaires

Interventions

  • OtherPrélèvement sanguin (2*4mL) ou médullaire (2mL)

    Additional blood (2\*4mL) or bone marrow (2mL) sample depending on clinical presentation of disease

  • OtherData collection through questionnaires

    Collection of quality of life and occupational exposure data via questionnaires

06

What researchers measure

Primary outcomes

  1. Describe the mechanisms of resistance of myeloma cells.

    Number of resistance.

    Time frame: 15 years

07

Study locations

2 of 2 sites recruiting
  • La Roche sur Yon Hospital Departmental
    La Roche-sur-Yon, 85000, France
    Recruiting
  • Nantes University Hospital
    Nantes, 44093, France
    Recruiting
08

References and documents

Publications

  • Derrien 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03807128
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Jan 16, 2019
Start date
Feb 11, 2019
Primary completion
Feb 11, 2034 (estimated)
Completion
Feb 11, 2049 (estimated)
Last update
Jul 14, 2025

Study contacts

Cyrille TOUZEAU, PU
Contact
cyrille.touzeau@chu-nantes.fr
02 40 08 32 71
Cyrille TOUZEAU, PU
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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