Multiple MyelomaNCT06255639
Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse
An observational study of Multiple Myeloma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2020to Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from multiple myeloma (MM) with multiple vertebral lesions and candidates for vertebroplasty, consecutively diagnosed with MM in the period from 2015 to 2021 at the study center
Who may be able to join
- Age≥ 18 years;
- Diagnosis of multiple myeloma;
- Clinical indication and eligibility for vertebroplasty procedure;
- Performance Status (ECOG) 0-2;
- Life expectancy greater than three months;
- Low-resolution full skeletal CT scan at disease onset and/or at follow-up;
- Spine pain with stiffness and functional impediment pre vertebroplasty;
- Able to express appropriate consent for participation in the study (e.g. Able to understand Italian, patient with intact cognitive abilities)
Who cannot join
- presence of spinal cord compressions;
- unstable spinal injuries, requiring an orthopaedic back brace;
- risk of spinal cord injury;
- body mass index BMI>28 kg/m2.
- absence of signed informed consent form
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Aviano, Pordenone, 33081
Mariagrazia Michieli, MD, 0434 659 020, mmichieli@cro.it
Mariagrazie Michieli, MD
About this study
In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM
Read the detailed description
In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
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 |
|---|---|---|
| MM patient candidate to vertebroplasty | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean of kinematic data for walking before and after vertebroplasty
Difference in mean of kinematic data for walking before and after vertebroplasty
Measured: 2 months
difference in mean of movement range for affected joints before and after vertebroplasty
difference in mean of movement range for affected joints before and after vertebroplasty
Measured: 2 months
Difference in mean of energy expenditure before and after vertebroplasty
Difference in mean of energy expenditure before and after vertebroplasty
Measured: 2 months
Secondary outcomes (5)
To explore the impact of vertebroplasty on thermal parameters
Central and superficial temperature will be measured before and after vertebroplasty. Difference will be reported as intrapatient mean difference
Measured: 2 months
To explore the impact of vertebroplasty on metabolic parameters
Carbon dioxide production after 30 minutes of walking will be measured before and after vertebroplasty and intrapatient mean difference will be reported.
Measured: 2 months
To explore the impact of vertebroplasty on metabolic parameters
Cardiac frequency after 30 minutes of walking will be measured before and after vertebroplasty and intrapatient mean difference will be reported.
Measured: 2 months
To explore the impact of vertebroplasty on metabolic parameters
Oxygen consumption after 30 minutes of walking will be measured before and after vertebroplasty and intrapatient mean difference will be reported.
Measured: 2 months
To explore the impact of vertebroplasty on pain
Perceived pain will be measured using the Brief Pain Inventory scale (BPI) before and after vertebroplasty. Difference will be reported as intrapatient mean difference. BPI values range between 0 and 10, with higher scores meaning worst pain
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Oct 2020
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariagrazia Michieli, MD, Principal investigator, Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255639
- Sponsor's protocol ID
- CRO-2020-35
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical and Metabolic Assessment Pre and Post Vertebroplasty in Multiple Myeloma Patients With Vertebral Collapse
- ClinicalTrials.gov ID
- NCT06255639
- Acronym / sponsor ID
- CRO-2020-35
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Feb 2024 (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.
In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM
Detailed description
In patients with Multiple Myeloma (MM), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. The introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. Despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. The aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with MM
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MM patient candidate to vertebroplasty | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from multiple myeloma (MM) with multiple vertebral lesions and candidates for vertebroplasty, consecutively diagnosed with MM in the period from 2015 to 2021 at the study center
Key inclusion criteria (8 listed)
- Age≥ 18 years;
- Diagnosis of multiple myeloma;
- Clinical indication and eligibility for vertebroplasty procedure;
- Performance Status (ECOG) 0-2;
- Life expectancy greater than three months;
Key exclusion criteria (5 listed)
- presence of spinal cord compressions;
- unstable spinal injuries, requiring an orthopaedic back brace;
- risk of spinal cord injury;
- body mass index BMI>28 kg/m2.
- absence of signed informed consent form
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
Difference in mean of kinematic data for walking before and after vertebroplasty
Time frame: 2 months
Difference in mean of kinematic data for walking before and after vertebroplasty
difference in mean of movement range for affected joints before and after vertebroplasty
Time frame: 2 months
difference in mean of movement range for affected joints before and after vertebroplasty
Difference in mean of energy expenditure before and after vertebroplasty
Time frame: 2 months
Difference in mean of energy expenditure before and after vertebroplasty
5 secondary outcomes
To explore the impact of vertebroplasty on thermal parameters
Time frame: 2 months
To explore the impact of vertebroplasty on metabolic parameters
Time frame: 2 months
To explore the impact of vertebroplasty on metabolic parameters
Time frame: 2 months
To explore the impact of vertebroplasty on metabolic parameters
Time frame: 2 months
To explore the impact of vertebroplasty on pain
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
Mariagrazia Michieli, MD principal investigator
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
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 Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
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 8 inclusion and 5 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 13 Feb 2024. 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 Italy. 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?
Contact Mariagrazia Michieli, MD (0434 659 020, mmichieli@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean of kinematic data for walking before and after vertebroplasty (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.