Multiple MyelomaNCT05996367
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
A study testing Single-dose involved-site radiotherapy in people with Multiple Myeloma, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main treatment for these lesions and pain control is radiotherapy, usually in daily fractions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Single-dose involved-site radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jul 2023to 1 Oct 2024
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy of plasma cell neoplasm with bone lesion treatable with radiotherapy;
- Age between 18 and 85 years old;
- Performance on the ECOG scale less than or equal to 2.
- Not using systemic therapies for 4 weeks OR being on maintenance therapy with the same drug for at least 4 weeks before radiotherapy.
Who cannot join
- Refusing to sign or inability to understand the consent term;
- Pain less than 2/10 on the numeric pain rating scale;
- Change in systemic treatment scheme, including use of bone metabolism modulation drugs, up to 4 weeks before radiotherapy treatment;
- Technical incapacity for the treatment, including, but not limited to, weight greater than 115Kg, inability to abduct the limb to be treated in appendicular bones, intolerable pain to remain in the treatment position;
- Previous cancer and previous oncological treatments;
- Previous autoimmune diseases, even if controlled;
- Current pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In 2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without description of several important oncological outcomes. This is a single-arm prospective cohort study. This study aims to describe these outcomes, including retreatment rate and bone events. Also, as secondary objectives, describe the quality of life and use of analgesic medications in this population.
- Conditions
- Multiple Myeloma
- Being tested
- Single-dose involved-site radiotherapy
- Keywords
- Multiple myeloma, Palliative care, Radiotherapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-dose involved-site radiotherapyRadiation
Single-dose of 8 Gy at involved-site radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Single-dose radiation to involved-site Receives: Radiation: Single-dose involved-site radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retreatment rate at 6 months
Percentage of patients that needed a second corse of radiation for painful bone lesions
Measured: 6 months after radiotherapy
Secondary outcomes (8)
Local control
Local control by Recist 1.1
Measured: 6 months and 12 months
Progression-free survival
Progression-free survival
Measured: 12 months
Overall survival
Overall survival
Measured: 12 months
Bone event-free survival
by description from Raje et al. The Lancet 2018
Measured: 6 months
Pain relief by the numerical rating pain scale
reduction on opioid and single analgesics intake and altered value in the rating pain scale
Measured: 1, 3, 6 and 12 months
Pain flair incidence
Enhanced pain by at least 2 levels at the numerical rating pain scale
Measured: 1, 3, 6 and 12 months
Quality of life by EORCT QLQ-C30
Quality of life by EORCT QLQ-C30 questionnaire
Measured: 1, 6 and 12 months
Quality of life by EORCT QLQ-C30 and MY-24
Quality of life by EORCT MY-24 myeloma complementary questionnaires
Measured: 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start31 Jul 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Funding/ transfer PI
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geovanne Pedro Mauro, Instituto do Cancer do Estado de São Paulo
- Investigators
- Geovanne P Mauro, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996367
- Sponsor's protocol ID
- NP 465/23
- Status last verified
- Sep 2024
- First submitted
- 31 Jul 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05996367
- Acronym / sponsor ID
- NP 465/23
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Palliative care, Radiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding/ transfer PI
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 18 Aug 2023 (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.
Multiple myeloma is a plasma cell neoplasm that can cause painful bone lesions. The main treatment for these lesions and pain control is radiotherapy, usually in daily fractions. In 2017, a phase III study proved the effectiveness of using a single dose of 8 Gy, but without description of several important oncological outcomes. This is a single-arm prospective cohort study. This study aims to describe these outcomes, including retreatment rate and bone events. Also, as secondary objectives, describe the quality of life and use of analgesic medications in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Radiation: Single-dose involved-site radiotherapySingle-dose radiation to involved-site |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy of plasma cell neoplasm with bone lesion treatable with radiotherapy;
- Age between 18 and 85 years old;
- Performance on the ECOG scale less than or equal to 2.
- Not using systemic therapies for 4 weeks OR being on maintenance therapy with the same drug for at least 4 weeks before radiotherapy.
Key exclusion criteria (7 listed)
- Refusing to sign or inability to understand the consent term;
- Pain less than 2/10 on the numeric pain rating scale;
- Change in systemic treatment scheme, including use of bone metabolism modulation drugs, up to 4 weeks before radiotherapy treatment;
- Technical incapacity for the treatment, including, but not limited to, weight greater than 115Kg, inability to abduct the limb to be treated in appendicular bones, intolerable pain to remain in the treatment position;
- Previous cancer and previous oncological treatments;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-dose involved-site radiotherapySingle-dose of 8 Gy at involved-site radiotherapy | Radiation | Single Arm |
Primary outcome
Retreatment rate at 6 months
Time frame: 6 months after radiotherapy
Percentage of patients that needed a second corse of radiation for painful bone lesions
8 secondary outcomes
Local control
Time frame: 6 months and 12 months
Progression-free survival
Time frame: 12 months
Overall survival
Time frame: 12 months
Bone event-free survival
Time frame: 6 months
Pain relief by the numerical rating pain scale
Time frame: 1, 3, 6 and 12 months
Pain flair incidence
Time frame: 1, 3, 6 and 12 months
Quality of life by EORCT QLQ-C30
Time frame: 1, 6 and 12 months
Quality of life by EORCT QLQ-C30 and MY-24
Time frame: 1, 6 and 12 months
Results and safety
The study was stopped early (reason given: Funding/ transfer PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Geovanne P Mauro, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-dose involved-site radiotherapy in people with Multiple Myeloma, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 7 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: stopped early, as of the sponsor's last update on 4 Nov 2026. 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 Brazil. 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?
The study was stopped early (reason given: Funding/ transfer PI). 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?
Retreatment rate at 6 months (time frame: 6 months after radiotherapy). 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 4 Nov 2026.