Phase II Multi-Institutional Study of Low-Dose (2Gy) Palliative Radiotherapy in the Treatment of Symptomatic Bone Metastases From Multiple Myeloma
University of Southern California
Summary
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.
Description
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 wit…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) * 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 i…
Interventions
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- RadiationRadiation Therapy
Receive low-dose radiation therapy
Locations (9)
- City of HopeDuarte, California
- Los Angeles General Medical CenterLos Angeles, California
- USC / Norris Comprehensive Cancer CenterLos Angeles, California
- Cedars Sinai Medical CenterLos Angeles, California
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia
- Dana-Farber Cancer InstituteBoston, Massachusetts