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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04111809
Other study ID # APH190198
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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