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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s, even if controlled; - Current pregnancy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

RADIATION

Single-dose involved-site radiotherapy

Single-dose of 8 Gy at involved-site radiotherapy

Locations (1)

University of Sao Paulo
São Paulo, São Paulo, Brazil