Prospective Cohort of Single-dose Radiotherapy for Painful Bone Lesions in Multiple Myeloma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorInstituto do Cancer do Estado de São Paulo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Single-dose involved-site radiotherapy

    Radiation

    Single-dose of 8 Gy at involved-site radiotherapy

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Retreatment rate at 6 months

Percentage of patients that needed a second corse of radiation for painful bone lesions

Time frame
6 months after radiotherapy

Secondary outcomes

1

Local control

Local control by Recist 1.1

Time frame
6 months and 12 months
2

Progression-free survival

Progression-free survival

Time frame
12 months
3

Overall survival

Overall survival

Time frame
12 months
4

Bone event-free survival

by description from Raje et al. The Lancet 2018

Time frame
6 months

Other outcomes

Sponsors and contacts

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