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Multiple Myeloma Minimal Residual Disease (MMRD)

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ClinicalTrials.gov Identifier: NCT02627261
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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

Condition or disease Intervention/treatment
Multiple Myeloma Biological: blood samples and bone marrow aspirates will be collected

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma
Study Start Date : November 2015
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
patients with multiple myeloma
blood samples and bone marrow aspirates will be collected in patients at different time point
Biological: blood samples and bone marrow aspirates will be collected
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. kinetic of variation of the residual tumor cells detected by flow cytometry method [ Time Frame: 18 months ]
    % positive cells in bone marrow sample

  2. kinetic of variation of the residual tumor cells detected by new generation sequencing method [ Time Frame: 18 months ]
    % positive in bone marrow sample

  3. kinetic of variation of the circulating tumor cells [ Time Frame: 18 months ]
    number of cells / mL of blood


Biospecimen Retention:   Samples With DNA
a gene sequencing technology will be used on bone marrow samples to detect residual disease


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • ≥ 18 years
  • previously undiagnosed myeloma
  • eligible for high dose therapy and bone marrow transplantation
  • signed consent

Exclusion Criteria:

  • ongoing therapy for another neoplasia
  • Patients with other hematologic malignancies,
  • patients deprived of liberty for administrative or judicial reasons
  • previously treated for myeloma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627261


Contacts
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Contact: Charles DUMONTET, PU-PH +33 4 78 86 41 28 charles.dumontet@chu-lyon.fr
Contact: Mina EDDAHBI +33 4 78 77 12 02 mina.eddahbi@chu-lyon.fr

Locations
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France
Hôpital Huriez Recruiting
Lille, France, 59037
Principal Investigator: Facon Thierry         
Centre Hospitalier Universitaire Hôtel-Dieu de Nantes Recruiting
Nantes, France, 44000
Principal Investigator: Moreau Philippe         
Centre Hospitalier Lyon Sud Recruiting
Pierre Bénité, France, 69495
Contact: Charles DUMONTET, PU-PH       charles.dumontet@chu-lyon.fr   
Sub-Investigator: Lionel KARLIN, PH         
Sub-Investigator: Sophie DUCASTELLE LEPRETRE, PH         
Sponsors and Collaborators
Hospices Civils de Lyon
Janssen, LP

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02627261     History of Changes
Other Study ID Numbers: 69HCL15_0316
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
residual disease

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases