NCT03702088

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

October 8, 2018

Last Update Submit

November 18, 2019

Conditions

Myeloma

Keywords

Minimal residual diseaseMulti-parametric flow cytometryHevylite®

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Sensitivity the Hevylite test

    1 day

  • negative predictive value of the Hevylite test

    1 day

  • specificity of the Hevylite test

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated for myeloma benefiting from a residual disease evaluation by cytometry according to the current practice.

You may qualify if:

  • 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

You may not qualify if:

  • \- No

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and bone marrow

MeSH Terms

Conditions

Neoplasms, Plasma CellNeoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laure Vincent, Md

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure Vincent, MD

CONTACT

467 33 24 18l-vincent@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

October 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

FR(1)