Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
Start Date
3/11/2019
Completion Date
3/11/2027
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.
Detailed 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 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Quality-of-Life Assessment
Questionnaire Administration
Radiation Therapy
Conditions
Locations
City of Hope
Duarte, California 91010
United States
Los Angeles General Medical Center
Los Angeles, California 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Minnesota - Masonic Cancer Center
Minneapolis, Minnesota 55455
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States