Multiple Myeloma
Conditions
Keywords
residual disease
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
Interventions
BIOLOGICALblood 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)
Sponsors
Janssen, LP
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| kinetic of variation of the circulating tumor cells | 18 months | number of cells / mL of blood |
Countries
France
Outcome results
None listed