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

NCT04111809 | Terminated

• 1 other identifier: APH190198
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; intravenous bisphosphonate; bone markers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• time to maximum variation of bone turnover markers

  Baseline, then every 2 months in 12 months

• Doses of intravenous bisphosphonate

  Up to 12 months

• Rate of intravenous bisphosphonate

  Up to 12 months

• evolution of bone lesions by imaging

  Up to 12 months

• Number of new bone events

  Up to 12 months

Study Arms (1)

intravenous biphosphonate

Patients treated with intravenous bisphosphonate until 12 months in routine care

Biological: Blood and urine collection

Interventions

Blood and urine collection BIOLOGICAL

collected 10 mL of blood and 15 mL of urine every 2 months until 12 months

intravenous biphosphonate

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

no description

You may qualify if:

• 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

You may not qualify if:

• \- Patients previously treated with intravenous biphosphonate

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Intergroupe Francophone du Myelome: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker Hospital, Adult haematology department

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum plasma urine

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: October 1, 2019
• Study Start: September 29, 2020
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)