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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with multiple myeloma | blood samples and bone marrow aspirates will be collected in patients at different time point |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood samples and bone marrow aspirates will be collected | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| kinetic of variation of the residual tumor cells detected by flow cytometry method | % positive cells in bone marrow sample | 18 months |
| kinetic of variation of the residual tumor cells detected by new generation sequencing method |
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Inclusion Criteria:
Exclusion Criteria:
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This study will focus on adult patients with multiple myeloma and who will receive a treatment with high-dose melphalan and autologous bone marrow transplantation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Huriez | Lille | 59037 | France | |||
| Centre Hospitalier Universitaire Hôtel-Dieu de Nantes |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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a gene sequencing technology will be used on bone marrow samples to detect residual disease
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% positive in bone marrow sample
| 18 months |
| kinetic of variation of the circulating tumor cells | number of cells / mL of blood | 18 months |
| Nantes |
| 44000 |
| France |
| Centre Hospitalier Lyon Sud | Pierre Bénité | 69495 | France |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |