Multiple Myeloma Minimal Residual Disease

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: blood samples and bone marrow aspirates will be collected

• Registration Number: NCT02627261
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11-23
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-10
• Primary Completion: 2018-09-02
• Study Completion: 2018-09-02
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with multiple myeloma	blood samples and bone marrow aspirates will be collected	blood samples and bone marrow aspirates will be collected in patients at different time point

Primary Outcome Measures

Name	Time	Method
Quantification of residual disease	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

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

Trial Locations

Locations (3)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Bénité, France

Centre Hospitalier Universitaire Hôtel-Dieu de Nantes; 🇫🇷 Nantes, France

Hôpital Huriez; 🇫🇷 Lille, France