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NCT03702088 Clinical Trial

Place of the Hevylite Test in the Evaluation of MRD in Myeloma

Myeloma Clinical Trial

Official title:
Place of the Hevylite Test in the Evaluation of MRD in Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03702088
Other study ID # RECHMPL18_0234
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date December 30, 2020

Study information
Verified date November 2019
Source University Hospital, Montpellier
Contact Laure Vincent, MD
Phone 467 33 24 18
Email l-vincent@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study aiming at testing the positive predictive value of the Hevylite blood test in detecting minimal residual disease in myeloma compared to an invasive method requiring bone marrow sample by multi-parametric flow cytometry

Description:

Multiple Myeloma is a pathology for which treatments are constantly progressing. These treatments allow more and more patients to reach deeper and deeper responses. Currently, it is possible to detect very low levels of disease : this is called the evaluation of minimal residual disease. Its prognostic value is strong.

Two techniques currently prevail in the evaluation of minimal residual disease: high throughput sequencing (NGS) and multi-parameter flow cytometry. They are included in evaluation criteria defined by the International Myeloma Working Group (IMWG). These techniques have the advantage of being very sensitive, reaching 10-5 (cytometry: 50 events among 5 000 000 cells analysed) to 10-6 (NGS). Nevertheless, they are invasive for the patient (medullary specimen), require technical expertise and are not necessarily available in all hospitals.

The development of blood tests would cope with this constraints.

The Hevylite® assay is a simple, sensitive, automated and inexpensive immunologic technique that allows the accurate quantification of total IgG, Total IgG, Total IgA, Total IgA L, Total IgM, and Total IgM in the blood. Given its characteristics, the Hevylite assay could play a role in the definition of MRD and allow evaluation of residual disease in myeloma.

This study aims to evaluate the positive predictive value of the Hevylite test in the evaluation of residual disease in myeloma in comparison with multiparametric flow cytometry on the bone marrow.

Recruitment information / eligibility
Status Recruiting
Enrollment 124
Est. completion date December 30, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

-All patients with myeloma in complete response defines as: Absence of monoclonal component on serum and urine electrophoresis Negative immunofixation on serum and urine Normal ratio of free light chains according to the standard Freelite® method

- Any number of treatment lines received

Exclusion criteria:

- No

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (5)
Lead Sponsor Collaborator
University Hospital, Montpellier Centre Hospitalier Universitaire de Nice, CHU de Nîmes, CLB de Lyon, Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary positive predictive value of the Hevylite test positive predictive value of the Hevylite test in the evaluation of residual disease in myeloma in comparison with multiparametric flow cytometry on the bone marrow 1 day
Secondary Sensitivity the Hevylite test Sensitivity the Hevylite test in the evaluation of residual disease in myeloma in comparison with multiparametric flow cytometry on the bone marrow 1 day
Secondary negative predictive value of the Hevylite test negative predictive value of the Hevylite test in the evaluation of residual disease in myeloma in comparison with multiparametric flow cytometry on the bone marrow 1 day
Secondary specificity of the Hevylite test specificity of the Hevylite test in the evaluation of residual disease in myeloma in comparison with multiparametric flow cytometry on the bone marrow 1 day
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