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Bone Pain in Multiple Myeloma- a Translational Study

NCT04273425 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2022-02-09

No results posted yet for this study

Summary

While the survival expectancy of myeloma patients continues increasing due to the discovery of novel treatments, bone pain remains one of the main symptoms of this patient population, impairing their mood and quality of life.

The aim of this study is to characterize the subjective experience of pain in myeloma patients, and its correlation with disturbances in serum biomarkers and bone innervation.

Primary research questions:

How is the bone pain experienced by myeloma patients (intensity, location and type of pain) and how does it affect their quality of life?

Do myeloma cells induce changes in the density and/or location of nerve fibres innervating the bone, and if so, are these correlated to the pain experience?

Secondary research questions:

Are the alterations in the bone innervation of myeloma patients similar to those of immunocompetent animal models of the disease (the 5TGM1 model)?

Is serum paraprotein correlated with the subjective experience of myeloma-induced bone pain?

Are the bone turnover biomarkers (C-terminal telopeptides Type 1 collagen, CTX, and procollagen type 1 N-terminal propeptide, P1NP) and inflammatory serum biomarkers correlated with the subjective experience of myeloma-induced bone pain?

Do myeloma cells affect the location, number or density of bone cells (e.g. osteoblasts, osteoclasts)?

Conditions

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew D Chantry, MD, PhD · Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2021-11-16
Completion
2022-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04273425 on ClinicalTrials.gov