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Completed

NCT Number: NCT02627261

Multiple Myeloma Minimal Residual Disease

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Huriez, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples and bone marrow aspirates will be collected

Biological

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Janssen, LP

Registry information

Official study title

Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma

Acronym: MMRD

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2015
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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