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

September 22, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker Hospital, Adult haematology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

no description

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intravenous biphosphonate
Patients treated with intravenous bisphosphonate until 12 months in routine care
Biological: Blood and urine collection
collected 10 mL of blood and 15 mL of urine every 2 months until 12 months

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin
Intergroupe Francophone du Myelome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Actual)

October 20, 2020

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APH190198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Blood and urine collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe