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

Multiple Myeloma Clinical Trial

— AMBROBiMM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111809
• Other study ID #: APH190198
• Status: Recruiting
• Start date: September 29, 2020
• Est. completion date: September 2023

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Laurent Frenzel, MD
• Phone: +33 (0)1 44 49 52 90
• Email: laurent.frenzel[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• Blood and urine collection
collected 10 mL of blood and 15 mL of urine every 2 months until 12 months

Locations

Country	Name	City	State
France	Necker Hospital, Adult haematology department	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Intergroupe Francophone du Myelome

Country where clinical trial is conducted

France, 

Outcome

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