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Inability to conduct the study
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| Name | Class |
|---|---|
| Intergroupe Francophone du Myelome | NETWORK |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous bisphosphonates in routine care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous biphosphonate | Patients treated with intravenous bisphosphonate until 12 months in routine care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and urine collection | Biological | collected 10 mL of blood and 15 mL of urine every 2 months until 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bone turnover markers | bone turnover markers include: C-terminal telopeptides of type I collagene (CTX) in serum, amino-terminal telopeptide of type 1 collagen (NTX) in urine, Dickkopf-1 (DKK-1) and Sclerostin (SOST) in plasma | Baseline, then every 2 months in 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| time to maximum variation of bone turnover markers | CTX, NTX, DKK-1 and SOST | Baseline, then every 2 months in 12 months |
| Doses of intravenous bisphosphonate | To study the relationship between doses and bone turnover markers |
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Inclusion Criteria:
Exclusion Criteria
- Patients previously treated with intravenous biphosphonate
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no description
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker Hospital, Adult haematology department | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| 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 |
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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serum plasma urine
| Up to 12 months |
| Rate of intravenous bisphosphonate | To study the relationship between doses and bone turnover markers | Up to 12 months |
| evolution of bone lesions by imaging | evolution of bone lesions by imaging | Up to 12 months |
| Number of new bone events | Up to 12 months |
| Number of adverse events likely to be related to bisphosphonate | Up to 12 months |
| Changes in Monoclonal protein | To evaluated response to treatment | Baseline, then every 2 months in 12 months |
| 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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |