Clinical trial · Interventional
Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma
Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single-dose involved-site radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Single-dose radiation to involved-site
- interventionNames
- Radiation: Single-dose involved-site radiotherapy
Primary outcomes (1)
- measure
- Retreatment rate at 6 months
- timeFrame
- 6 months after radiotherapy
- description
- Percentage of patients that needed a second corse of radiation for painful bone lesions
Secondary outcomes (8)
- measure
- Local control
- timeFrame
- 6 months and 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available