Multiple Myeloma and Malignant Plasma Cell NeoplasmsPhase 3NCT02024815
Comparable Investigation of One Fraction Radiotherapy and Multifraction Radiotherapy in Patients With Multiple Myeloma.
A Phase 3 study testing External Beam radiotherapy in people with Multiple Myeloma and Malignant Plasma Cell Neoplasms, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in the course of their illness. The relief of pain is obtained in 75 - 100%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma and Malignant Plasma Cell Neoplasms
- What is being tested?
- External Beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- Sep 2011to Jun 2015
- Phase
- Phase 3
- 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
Who may be able to join
- Karnofsky index more than 40%
- Patients with painful bone destructions.
- Patients with impending fracture in the region of destructions
Who cannot join
- Patients with bone metastases from solid tumors
- Patients with solitary plasmacytoma
- Patients who had received previous irradiation to the present painful destruction site,
- Patients who were incapable to complete the quality of life questionnaires
- Patients with poor health status .
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Oncology Institute of Lithuanian of Health Sciences
Kaunas, 50009
About this study
Official title: Comparable Investigation of One Fraction Radiotherapy (8 Gy x 1) and Multifraction Radiotherapy (3 Gy x 10) of Painful Bone Destructions in Patients With Multiple Myeloma.
Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in the course of their illness. The relief of pain is obtained in 75 - 100%. Recalcification is achieved in 40 - 50% of the irradiated bone destructions.There were a lot of randomized trials showed the same effect of single (SF) and multiple fractions (MF) in pain relief and recalcification for patients with painful bone metastases from solid tumors. The role of different palliative radiotherapeutic regimens for MM is not well established due to lack of clinical trials. Our prospective study analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, analgesics consumption and recalcification.
Read the detailed description
The primary aim of our prospective study is to analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, the secondary aim is to analyzed the effect of two different radiotherapeutic regimens in the analgesics consumption and recalcification.
Eligibility criteria are age more than 18 years, Karnofsky index more than 40%, patients with painful bone destructions, patients with impending fracture in the region of destructions.
Exclusion Criteria are: patients with bone metastases from solid tumors, patients with solitary plasmacytoma, patients who had received previous irradiation to the present painful destruction site, patients who were incapable to complete the quality of life questionnaires, patients with poor health status.
- Being tested
- External Beam 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.
External Beam radiotherapyRadiation
External Beam radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| External Beam radiotherapy | Experimental | Single 8 Gy fraction Receives: Radiation: External Beam radiotherapy |
| 3 Gy x 10 fractions | Active comparator | External Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction. Receives: Radiation: External Beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyzed the pain relief in visual analogue scalewith the scale endpoints from 0 to 10 of two different radiotherapeutic regimens.
Measured: At admission and after 4, 12 and 24 weeks after radiotherapy
Secondary outcomes (1)
To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.
Measured: At admission and after 4, 12 and 24 weeks after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionJun 2015 (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 Myeloma and Malignant Plasma Cell NeoplasmsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturas Inciura, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024815
- Sponsor's protocol ID
- MM81310
- Status last verified
- Dec 2013
- First submitted
- 19 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rudzianskiene M, Inciura A, Gerbutavicius R, Rudzianskas V, Ugenskiene R, Paukstaitiene R, Dambrauskiene R, Vaitiekus D, Kulboke M, Juozaityte E. The influence of polymorphisms in cytokine genes on pain and response to palliative radiotherapy in multiple myeloma patients: prospective observational study. Scand J Pain. 2026 Mar 13;26(1). doi: 10.1515/sjpain-2025-0013. eCollection 2026 Jan 1.
PubMed 41832666
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparable Investigation of One Fraction Radiotherapy (8 Gy x 1) and Multifraction Radiotherapy (3 Gy x 10) of Painful Bone Destructions in Patients With Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT02024815
- Acronym / sponsor ID
- MM81310
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 31 Dec 2013 (estimated)
- 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.
Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in the course of their illness. The relief of pain is obtained in 75 - 100%. Recalcification is achieved in 40 - 50% of the irradiated bone destructions.There were a lot of randomized trials showed the same effect of single (SF) and multiple fractions (MF) in pain relief and recalcification for patients with painful bone metastases from solid tumors. The role of different palliative radiotherapeutic regimens for MM is not well established due to lack of clinical trials. Our prospective study analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, analgesics consumption and recalcification.
Detailed description
The primary aim of our prospective study is to analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, the secondary aim is to analyzed the effect of two different radiotherapeutic regimens in the analgesics consumption and recalcification.
Eligibility criteria are age more than 18 years, Karnofsky index more than 40%, patients with painful bone destructions, patients with impending fracture in the region of destructions.
Exclusion Criteria are: patients with bone metastases from solid tumors, patients with solitary plasmacytoma, patients who had received previous irradiation to the present painful destruction site, patients who were incapable to complete the quality of life questionnaires, patients with poor health status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Beam radiotherapy | Experimental | Radiation: External Beam radiotherapySingle 8 Gy fraction |
| 3 Gy x 10 fractions | Active comparator | Radiation: External Beam radiotherapyExternal Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Karnofsky index more than 40%
- Patients with painful bone destructions.
- Patients with impending fracture in the region of destructions
Key exclusion criteria (5 listed)
- Patients with bone metastases from solid tumors
- Patients with solitary plasmacytoma
- Patients who had received previous irradiation to the present painful destruction site,
- Patients who were incapable to complete the quality of life questionnaires
- Patients with poor health status .
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 |
|---|---|---|
| External Beam radiotherapyExternal Beam radiotherapy | Radiation | 3 Gy x 10 fractions, External Beam radiotherapy |
Primary outcome
To analyzed the pain relief in visual analogue scalewith the scale endpoints from 0 to 10 of two different radiotherapeutic regimens.
Time frame: At admission and after 4, 12 and 24 weeks after radiotherapy
1 secondary outcome
To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.
Time frame: At admission and after 4, 12 and 24 weeks after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Derived from this study: PubMed 41832666Rudzianskiene M, Inciura A, Gerbutavicius R, Rudzianskas V, Ugenskiene R, Paukstaitiene R, Dambrauskiene R, Vaitiekus D, Kulboke M, Juozaityte E. The influence of polymorphisms in cytokine genes on pain and response to palliative radiotherapy in multiple myeloma patients: prospective observational study. Scand J Pain. 2026 Mar 13;26(1). doi: 10.1515/sjpain-2025-0013. eCollection 2026 Jan 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing External Beam radiotherapy in people with Multiple Myeloma and Malignant Plasma Cell Neoplasms, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 3 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 31 Dec 2013. 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 Lithuania. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To analyzed the pain relief in visual analogue scalewith the scale endpoints from 0 to 10 of two different radiotherapeutic regimens. (time frame: At admission and after 4, 12 and 24 weeks after radiotherapy). 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 NCT02024815, 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 31 Dec 2013.