Study of 4 Bone Turnover Markers in Patients With Multiple Myeloma Treated With Intravenous Bisphosphonate in Routine Care

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of 4 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 Multiple Myeloma Patients Treated With Intravenous Bisphosphonate

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Biological: Blood and urine collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 65 to 75 years of age Patient with symptomatic multiple myeloma as defined by the criteria of the IMWG Need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (PET-scanner preferentially) in routine care Ability and willingness to follow scheduled visits with requested biological samples Exclusion Criteria - Patients previously treated with intravenous biphosphonate

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intravenous biphosphonate<br>Patients treated with intravenous bisphosphonate until 12 months in routine care | Biological: Blood and urine collection<br>* collected 10 mL of blood and 15 mL of urine every 2 months until 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, intravenous bisphosphonate, bone markers