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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2022

Interventions

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

Arms, Groups and Cohorts

  • intravenous biphosphonate
    • Patients treated with intravenous bisphosphonate until 12 months in routine care

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Intergroupe Francophone du Myelome
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Laurent Frenzel, MD, +33 (0)1 44 49 52 90, laurent.frenzel@aphp.fr

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