Multiple Myeloma Minimal Residual Disease

Multiple Myeloma Clinical Trial

— MMRD  

Official title:

Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627261
• Other study ID #: 69HCL15_0316
• Status: Completed
• Start date: November 23, 2015
• Est. completion date: September 2, 2018

Study information

• Verified date: September 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2, 2018
• Est. primary completion date: September 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• 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)

Locations

Country	Name	City	State
France	Hôpital Huriez	Lille
France	Centre Hospitalier Universitaire Hôtel-Dieu de Nantes	Nantes
France	Centre Hospitalier Lyon Sud	Pierre Bénité

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Janssen, LP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of residual disease	study the sensitivity of the method of quantification of circulating tumor cells compared to 2 others methods of detection	Residual disease is assessed up to 18 months after inclusion
Secondary	kinetic of variation of the residual tumor cells detected by flow cytometry method	% positive cells in bone marrow sample	18 months
Secondary	kinetic of variation of the residual tumor cells detected by new generation sequencing method	% positive in bone marrow sample	18 months
Secondary	kinetic of variation of the circulating tumor cells	number of cells / mL of blood	18 months