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CompletedNCT02627261MMRDUpdated Sep 6, 2022

Multiple Myeloma Minimal Residual Disease

An observational study in Multiple Myeloma, sponsored by Hospices Civils de Lyon. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-06.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
All
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Study 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

02

Conditions studied

  • Multiple Myeloma

Keywords

  • residual disease
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In context

Multiple Myeloma

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

This study's enrollment of 48 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • Biologicalblood 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)

06

What researchers measure

Primary outcomes

  1. Quantification of residual disease

    study the sensitivity of the method of quantification of circulating tumor cells compared to 2 others methods of detection

    Time frame: Residual disease is assessed up to 18 months after inclusion

Secondary outcomes

  1. kinetic of variation of the residual tumor cells detected by flow cytometry method

    % positive cells in bone marrow sample

    Time frame: 18 months

  2. kinetic of variation of the residual tumor cells detected by new generation sequencing method

    % positive in bone marrow sample

    Time frame: 18 months

  3. kinetic of variation of the circulating tumor cells

    number of cells / mL of blood

    Time frame: 18 months

07

Study locations

3 sites
  • Hôpital Huriez
    Lille, 59037, France
  • Centre Hospitalier Universitaire Hôtel-Dieu de Nantes
    Nantes, 44000, France
  • Centre Hospitalier Lyon Sud
    Pierre Bénité, 69495, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02627261
Lead sponsor
Hospices Civils de Lyon
Collaborators
Janssen, LP
Responsible party
Sponsor
First posted
Dec 10, 2015
Start date
Nov 23, 2015
Primary completion
Sep 2, 2018
Completion
Sep 2, 2018
Last update
Sep 6, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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