Multiple Myeloma Minimal Residual Disease (MMRD)

September 2, 2022 updated by: Hospices Civils de Lyon

Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hôpital Huriez
      • Nantes, France, 44000
        • Centre Hospitalier Universitaire Hôtel-Dieu de Nantes
      • Pierre Bénité, France, 69495
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Residual disease is assessed up to 18 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
kinetic of variation of the residual tumor cells detected by flow cytometry method
Time Frame: 18 months
% positive cells in bone marrow sample
18 months
kinetic of variation of the residual tumor cells detected by new generation sequencing method
Time Frame: 18 months
% positive in bone marrow sample
18 months
kinetic of variation of the circulating tumor cells
Time Frame: 18 months
number of cells / mL of blood
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Collaborators

Janssen, LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2015

Primary Completion (Actual)

September 2, 2018

Study Completion (Actual)

September 2, 2018

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL15_0316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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