Multiple Myeloma Minimal Residual Disease

NCT ID: NCT02627261

Last Updated: 2022-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-23

Study Completion Date

2018-09-02

Brief Summary

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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

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with multiple myeloma

blood samples and bone marrow aspirates will be collected in patients at different time point

blood samples and bone marrow aspirates will be collected

Intervention Type 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)

Interventions

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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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen, LP

INDUSTRY

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Huriez

Lille, , France

Site Status

Centre Hospitalier Universitaire Hôtel-Dieu de Nantes

Nantes, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre Bénité, , France

Site Status

Countries

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France

Other Identifiers

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69HCL15_0316

Identifier Type: -

Identifier Source: org_study_id

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