Clinical trial · Observational
Bone Pain in Multiple Myeloma- a Translational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Study cohort (Confirmed myeloma patients)
- description
- Patients with suspected multiple myeloma will be recruited. They will be asked to fill in questionnaires (regarding pain, quality of life, catastrophizing), donate serum samples and allow the research team to access their clinical data and their diagnostic bone biopsy. Those who receive a positive diagnosis will be followed up upon completion of first-line treatment, and questionnaire data and blood samples collected again.
- label
- Control cohort (non-confirmed myeloma patients)
- description
- Patients with suspected multiple myeloma will be recruited. They will be asked to fill in questionnaires (regarding pain, quality of life, catastrophizing), donate serum samples and allow the research team to access their clinical data and their diagnostic bone biopsy. Samples from patients who receive a negative myeloma diagnosis will be used as negative controls.
Primary outcomes (7)
- measure
- Change in bone innervation by immunohistological assessment (presence)
- timeFrame
- Change from baseline to completion of first line treatment (expected to be measured at 8 months after baseline; expected to be reported within 2 years from baseline) for patients with a positive myeloma diagnosis.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older * Undergoing diagnostic procedures for suspected myeloma (no previous treatment for this) * Patients who are local to Sheffield (or who are local to any other institute that may join in collaboration) * Must be able to give informed consent Exclusion Criteria: * Patient who are unable to give consent * Patients who do not speak English * Patients who are too unwell to be recruited * Patients who have had recent chemotherapy for different malignancy
References
Publications (1)
- DERIVEDDiaz-delCastillo M, Andrews RE, Mandal A, Andersen TL, Chantry AD, Heegaard AM. Bone Pain in Multiple Myeloma (BPMM)-A Protocol for a Prospective, Longitudinal, Observational Study. Cancers (Basel). 2021 Mar 30;13(7):1596. doi: 10.3390/cancers13071596. PMID 33808348