Bone Pain in Multiple Myeloma- a Translational Study

NCT04273425 | Unknown

• 1 other identifier: STH20993
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Myeloma

Keywords

Pain

Outcome Measures

Primary Outcomes (7)

• Change in bone innervation by immunohistological assessment (presence)

  The presence of sympathetic and sensory nerve fibers innervating the bone will be assessed in the diagnostic trephine bone biopsies.

  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.

• Change in bone innervation by immunohistological assessment (location)

  The location sympathetic and sensory nerve fibers innervating the bone will be assessed in the diagnostic trephine bone biopsies.

  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.

• Change in bone innervation by immunohistological assessment (density)

  The density of sympathetic and sensory nerve fibers innervating the bone will be assessed in the diagnostic trephine bone biopsies.

  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.

• Characterization of pain in patients with firstly-diagnosed myeloma through standardized questionnaires (Brief Pain Inventory (BPI), FACT-BP(FACT-Bone Pain), PCS (Pain catastrophizing scale), painDETECT)

  Questionnaires will be used to characterize the self-reported experience of pain in patients with firstly-diagnosed myeloma

  Baseline

• Characterization of quality of life in patients with firstly-diagnosed myeloma through standardized questionnaires (EORTC QLQ-C30 (core 30) , EORT QLQ-MY20 (myeloma module 20), EORTC QLQ-CIPN20 (chemotherapy-induced peripheral neuropathy module 20) )

  Questionnaires will be used to characterize the quality of life of patients with firstly-diagnosed myeloma

  Baseline

• Change in quality of life in myeloma after first-line treatment through standardized questionnaires (EORTC QLQ-C30, EORT QLQ-MY20, EORTC QLQ-CIPN20)

  Questionnaires will be used to characterize the quality of life of patients with firstly-diagnosed myeloma and after completion of first-line treatment

  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.

• Change in pain in myeloma after first-line treatment through standardized questionnaires (BPI, FACT-BP, PCS, painDETECT)

  Questionnaires will be used to characterize the experience of pain in patients with firstly-diagnosed myeloma and after completion of first-line treatment

  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.

Secondary Outcomes (2)

• Change in serum bone biomarkers (CTX1, P1NP) measured by ELISA

  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.

• Change in inflammatory serum biomarkers measured by multiplex array.

  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.

Study Arms (2)

Study cohort (Confirmed myeloma patients)

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.

Control cohort (non-confirmed myeloma patients)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing diagnostic procedures for suspected multiple myeloma at Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Sheffield, UK.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Copenhagen: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (1)

• Diaz-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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Myeloma cells will be collected and frozen for subsequent genetic analyses.

MeSH Terms

Conditions

Multiple Myeloma; Pain

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew D Chantry, MD, PhD

  Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 18, 2020
• Study Start: October 23, 2019
• Primary Completion: November 16, 2021
• Study Completion: December 31, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)