Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma

Официальное название

Phase II Multi-Institutional Study of Low-Dose (2Gy) Palliative Radiotherapy in the Treatment of Symptomatic Bone Metastases From Multiple Myeloma

Обзор

This phase II trial studies how well low-dose radiotherapy works in treating bone pain in patients with multiple myeloma that has spread to the bone. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. Low-dose radiotherapy may be more convenient for patients and their families, may not interfere as much with the timing of chemotherapy, and may have less chance for short term or long-term side effects from the radiation.

Подробное описание

PRIMARY OBJECTIVES:

I. To determine whether treatment with 2 Gy x 2 to a painful myeloma bone lesion achieves patient-reported pain reduction comparable to current standard of care at 4 weeks.

SECONDARY OBJECTIVES:

I. To assess quality of life (QOL) in patients treated with 2 Gy x 2 to painful myeloma bone lesions.

II. To quantify analgesia use/reduction following 2 Gy x 2 to a painful myeloma bone lesion. All opioid analgesia use will be converted into morphine equivalent in order to compare across the entire population.

III. To measure time to pain relief and duration of pain relief with 2 Gy x 2.

EXPLORATORY OBJECTIVES:

I. To record cytogenetics and International Myeloma Working Group (IMWG) response criteria at diagnosis and prior to and following radiotherapy (RT).

OUTLINE:

Patients receive low-dose radiation therapy at consecutive business days 1 and 2 in the absence of disease progression or unacceptable toxicity. Patients with no pain relief may receive additional radiotherapy at 4 weeks following initial radiotherapy.

After completion of study treatment, patients are followed up at 2, 4, and 8 weeks and also at 6 months.

Вмешательства

• Другое Quality-of-Life Assessment
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies
• Лучевая терапия Radiation Therapy
  Receive low-dose radiation therapy

Первичные конечные точки

• Pain response [Срок оценки: Up to 6 months after completion of radiation therapy]

Вторичные конечные точки (2)

• Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22) [Срок оценки: Up to 6 months after completion of radiation therapy]
• Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC QLQ-C30) [Срок оценки: Up to 6 months after completion of radiation therapy]

Критерии участия

Критерии включения

• Histologic diagnosis of multiple myeloma
• Painful bone metastasis (index lesion) that has a radiographic correlate
• Patient may have had any number of prior chemotherapy/immunotherapy regimens (changes to systemic therapy or use of bisphosphonates for 4 weeks before and after RT are allowed, but recording of these changes must be made so it can be accounted for)
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Brief Pain Inventory (BPI) score >= 2
• Ability to understand and the willingness to sign a written informed consent

Критерии исключения

• Patients will be ineligible if the index lesion has received prior radiation therapy or prior palliative surgery. Patients may have received prior palliative or primary radiotherapy or surgery to other parts of the body, as long as the index lesion was not in the prior radiation fields and has not received prior palliative surgery
• Patients will also be ineligible if there is pathologic fracture or impending fracture at the site of the index lesion or planned surgical fixation of the bone at the index lesion
• Patients with clinical or radiographic evidence of spinal cord or cauda equina compression/effacement from the index lesion, and/or with index lesions located at the skull base or orbital lesions
• Patients must not be pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• City of Hope — Duarte
• Los Angeles General Medical Center — Los Angeles
• USC / Norris Comprehensive Cancer Center — Los Angeles
• Cedars Sinai Medical Center — Los Angeles
• Emory University Hospital/Winship Cancer Institute — Atlanta
• Dana-Farber Cancer Institute — Boston
• University of Minnesota - Masonic Cancer Center — Minneapolis
• Icahn School of Medicine at Mount Sinai — New York
• … и ещё 1 центр

Идентификаторы

NCT: NCT03858205 · 16M-18-2 · NCI-2018-03600 · 16M-18-2 · P30CA014089

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗