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

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Biological: Blood and urine collection

• Registration Number: NCT04111809
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Study Start: 2020-09-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patient aged 65 to 75 years of age
2. Patient with symptomatic multiple myeloma as defined by the criteria of the IMWG
3. Need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (PET-scanner preferentially) in routine care
4. Ability and willingness to follow scheduled visits with requested biological samples

Exclusion Criteria

• Patients previously treated with intravenous biphosphonate

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intravenous biphosphonate	Blood and urine collection	Patients treated with intravenous bisphosphonate until 12 months in routine care

Primary Outcome Measures

Name	Time	Method
Changes in bone turnover markers	Baseline, then every 2 months in 12 months	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

Secondary Outcome Measures

Name	Time	Method
time to maximum variation of bone turnover markers	Baseline, then every 2 months in 12 months	CTX, NTX, DKK-1 and SOST
Doses of intravenous bisphosphonate	Up to 12 months	To study the relationship between doses and bone turnover markers
Rate of intravenous bisphosphonate	Up to 12 months	To study the relationship between doses and bone turnover markers
Number of adverse events likely to be related to bisphosphonate	Up to 12 months
evolution of bone lesions by imaging	Up to 12 months	evolution of bone lesions by imaging
Number of new bone events	Up to 12 months
Changes in Monoclonal protein	Baseline, then every 2 months in 12 months	To evaluated response to treatment

Trial Locations

Locations (1)

Necker Hospital, Adult haematology department; 🇫🇷 Paris, France