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NCT Number: NCT05996367

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

São Paulo, 05403-010, Brazil

Location status: Recruiting

Location contact

Geovanne Mauro, PhD

CONTACT

[email protected]

+551126617058

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single-dose involved-site radiotherapy

Radiation

Single-dose of 8 Gy at involved-site radiotherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Local control

    Time frame: 6 months and 12 months

    Local control by Recist 1.1

  2. Progression-free survival

    Time frame: 12 months

    Progression-free survival

  3. Overall survival

    Time frame: 12 months

    Overall survival

  4. Bone event-free survival

    Time frame: 6 months

    by description from Raje et al. The Lancet 2018

  5. Pain relief by the numerical rating pain scale

    Time frame: 1, 3, 6 and 12 months

    reduction on opioid and single analgesics intake and altered value in the rating pain scale

  6. Pain flair incidence

    Time frame: 1, 3, 6 and 12 months

    Enhanced pain by at least 2 levels at the numerical rating pain scale

  7. Quality of life by EORCT QLQ-C30

    Time frame: 1, 6 and 12 months

    Quality of life by EORCT QLQ-C30 questionnaire

  8. Quality of life by EORCT QLQ-C30 and MY-24

    Time frame: 1, 6 and 12 months

    Quality of life by EORCT MY-24 myeloma complementary questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Geovanne P Mauro, PhD

CONTACT

[email protected]

+551126617058

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Official study title

Prospective Cohort Assessing the Impact of Single-dose Radiotherapy in the Treatment of Painful Bone Lesions in Patients With Multiple Myeloma

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Aug 18, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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