Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients with Multiple Myeloma
Plasma cell neoplasm
18 Years and older, Male and Female
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.
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.
I. To assess quality of life (QOL) in patients treated with 4 Gy to painful myeloma bone lesions.
II. 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.
III. To measure time to pain relief and duration of pain relief with 4 Gy.
IV. To assess pain relief in patients with more than 1 index lesion.
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.
Patients receive low-dose radiation therapy on study. 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.
- 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
Treatment Sites in Georgia
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