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Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients with Multiple Myeloma
Trial Status: temporarily closed to accrual
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.
Inclusion Criteria
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)
Age >= 18 years
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
Exclusion Criteria
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 a pathologic fracture or impending fracture in a long bone or if there is 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03858205.
I. To determine whether treatment with 4 Gy to a painful myeloma bone lesion achieves patient-reported pain reduction comparable to historical controls at 4 weeks.
SECONDARY OBJECTIVES:
I. To quantify analgesia use/reduction following 4 Gy to a painful myeloma bone lesion. All opioid analgesia use will be converted into morphine equivalent in order to compare across the entire population.
II. To measure time to pain relief and duration of pain relief with 4 Gy.
III. To assess pain relief in patients with more than 1 index lesion.
EXPLORATORY OBJECTIVES:
I. To record cytogenetics and International Myeloma Working Group (IMWG) response criteria at diagnosis and prior to and following radiotherapy (RT).
II. To evaluate pain response at index lesion after the 2nd course of radiation (reirradiation), if required.
III. To assess quality of life (QOL) in patients treated with 4 Gy to painful myeloma bone lesions.
OUTLINE:
Patients receive low-dose radiation therapy over 1 or 2 consecutive business days in the absence of disease progression or unacceptable toxicity. Patients with no pain relief may receive additional radiotherapy at 4 weeks following initial radiotherapy. Additionally, patients undergo bone scan, computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) during screening.
After completion of study treatment, patients are followed up at 2, 4, and 8 weeks and also at 6 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationUSC / Norris Comprehensive Cancer Center
