Multiple MyelomaBPMMNCT04273425
Bone Pain in Multiple Myeloma- a Translational Study
An observational study of Multiple Myeloma, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing diagnostic procedures for suspected multiple myeloma at Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Sheffield, UK.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
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.
Read more
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)?
Read the detailed description
Patients undergoing diagnostic procedures (i.e. trephine bone biopsy) for suspected multiple myeloma will be invited to participate in the study, and provided with time to consider their participation.
Patients who consent will be provided with a set of seven standardized questionnaires assessing their pain, quality of life and catastrophizing. Additionally, patients will be asked to fill in demographic information.
Consenting patients will be asked to donate a fasting blood sample and give permission to the research team to retrieve their triphane bone biopsy, once the medical team has finished evaluating it. The presence, location and density of nerve fibres innervating the bone will be evaluated. Patients will also be consented to allow retrieval of medical information from their medical records, and correlations between serum biomarkers, disturbances in bone innervation, paraprotein levels, etc. and their self-reported experience of pain will be investigated. Patients with a negative diagnosis for multiple myeloma (expectably monoclonal gammopathy of undetermined significance (MGUS) patients) will be used as negative controls.
Patients who receive a positive diagnosis for multiple myeloma will be asked to fill in the same set of questionnaires upon completion of the first-line treatment (approximately 7 to 8 months after baseline assessment). Fasting serum blood samples will be collected. To evaluate treatment´s success, it is common medical practice to extract a new trephine bone biopsy upon completion of first line treatment. The research team will access these biopsies and evaluate the presence, density and location of nerve fibres in bone. Changes in nerve fibre profiles, serum biomarkers and the self-reported experience of pain, quality of life and catastrophizing following first-line treatment will be evaluated.
- Conditions
- Multiple Myeloma
- Keywords
- Pain
- Medical subject headings
- Multiple Myeloma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measurement of bone turnover biomarkers in serum samples through enzyme-linked immunosorbent assay (ELISA).
Measured: 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.
Measurement of an set of inflammatory cytokines in serum samples through multiplex cytokine arrays.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start23 Oct 2019
- Primary completion16 Nov 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Andrew D Chantry, MD, PhD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273425
- Sponsor's protocol ID
- STH20993
- Acronym
- BPMM
- Status last verified
- Feb 2022
- First submitted
- 6 Feb 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data will be collected, stored and analyzed. The results of the study will be published in peer-reviewed scientific journals. Individual participant data will not be shared with the scientific or medical community unless specifically requested.
Publications
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.
PubMed 33808348
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Pain in Multiple Myeloma- a Translational Study
- ClinicalTrials.gov ID
- NCT04273425
- Acronym / sponsor ID
- BPMM / STH20993
- Conditions
- Multiple Myeloma
- Keywords
- Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
Detailed description
Patients undergoing diagnostic procedures (i.e. trephine bone biopsy) for suspected multiple myeloma will be invited to participate in the study, and provided with time to consider their participation.
Patients who consent will be provided with a set of seven standardized questionnaires assessing their pain, quality of life and catastrophizing. Additionally, patients will be asked to fill in demographic information.
Consenting patients will be asked to donate a fasting blood sample and give permission to the research team to retrieve their triphane bone biopsy, once the medical team has finished evaluating it. The presence, location and density of nerve fibres innervating the bone will be evaluated. Patients will also be consented to allow retrieval of medical information from their medical records, and correlations between serum biomarkers, disturbances in bone innervation, paraprotein levels, etc. and their self-reported experience of pain will be investigated. Patients with a negative diagnosis for multiple myeloma (expectably monoclonal gammopathy of undetermined significance (MGUS) patients) will be used as negative controls.
Patients who receive a positive diagnosis for multiple myeloma will be asked to fill in the same set of questionnaires upon completion of the first-line treatment (approximately 7 to 8 months after baseline assessment). Fasting serum blood samples will be collected. To evaluate treatment´s success, it is common medical practice to extract a new trephine bone biopsy upon completion of first line treatment. The research team will access these biopsies and evaluate the presence, density and location of nerve fibres in bone. Changes in nerve fibre profiles, serum biomarkers and the self-reported experience of pain, quality of life and catastrophizing following first-line treatment will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing diagnostic procedures for suspected multiple myeloma at Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Sheffield, UK.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in bone innervation by immunohistological assessment (presence)
Time frame: 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.
The presence of sympathetic and sensory nerve fibers innervating the bone will be assessed in the diagnostic trephine bone biopsies.
Change in bone innervation by immunohistological assessment (location)
Time frame: 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.
The location sympathetic and sensory nerve fibers innervating the bone will be assessed in the diagnostic trephine bone biopsies.
Change in bone innervation by immunohistological assessment (density)
Time frame: 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.
The density of sympathetic and sensory nerve fibers innervating the bone will be assessed in the diagnostic trephine bone biopsies.
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)
Time frame: Baseline
Questionnaires will be used to characterize the self-reported experience of pain in patients with firstly-diagnosed myeloma
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) )
Time frame: Baseline
Questionnaires will be used to characterize the quality of life of patients with firstly-diagnosed myeloma
Change in quality of life in myeloma after first-line treatment through standardized questionnaires (EORTC QLQ-C30, EORT QLQ-MY20, EORTC QLQ-CIPN20)
Time frame: 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.
Questionnaires will be used to characterize the quality of life of patients with firstly-diagnosed myeloma and after completion of first-line treatment
Change in pain in myeloma after first-line treatment through standardized questionnaires (BPI, FACT-BP, PCS, painDETECT)
Time frame: 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.
Questionnaires will be used to characterize the experience of pain in patients with firstly-diagnosed myeloma and after completion of first-line treatment
2 secondary outcomes
Change in serum bone biomarkers (CTX1, P1NP) measured by ELISA
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 33808348Diaz-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.
- Individual participant dataSharing planned: No. Anonymized data will be collected, stored and analyzed. The results of the study will be published in peer-reviewed scientific journals. Individual participant data will not be shared with the scientific or medical community unless specifically requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Chantry, MD, PhD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone innervation by immunohistological assessment (presence) (time frame: 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022; AzTrials last refreshed its copy on 3 Nov 2026.