NCT03807128

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
274mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Feb 2019Feb 2049

First Submitted

Initial submission to the registry

September 26, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2034

Expected
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2049

Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

15 years

First QC Date

September 26, 2018

Last Update Submit

July 9, 2025

Conditions

Multiple Myeloma

Keywords

MyelomaCohortResistanceQuality of life

Outcome Measures

Primary Outcomes (1)

  • Describe the mechanisms of resistance of myeloma cells.

    Number of resistance.

    15 years

Study Arms (1)

MYRACLE patients

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

Interventions

Prélèvement sanguin (2*4mL) ou médullaire (2mL)OTHER

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

MYRACLE patients
Data collection through questionnairesOTHER

Collection of quality of life and occupational exposure data via questionnaires

MYRACLE patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

La Roche sur Yon Hospital Departmental

La Roche-sur-Yon, 85000, France

RECRUITING

Nantes University Hospital

Nantes, 44093, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37653140DERIVED

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cyrille TOUZEAU, PU

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cyrille TOUZEAU, PU

CONTACT

02 40 08 32 71cyrille.touzeau@chu-nantes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

January 16, 2019

Study Start

February 11, 2019

Primary Completion (Estimated)

February 11, 2034

Study Completion (Estimated)

February 11, 2049

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations

FR(2)