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

Recruiting now · Not applicable

Conditions studied: Bone Pain, Metastatic Malignant Neoplasm in the Bone, Plasma Cell Myeloma

In brief

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.

Key facts

Study ID

NCT03858205

Run by

University of Southern California

People needed

100

Starts

2019-03-11

Expected to finish

2027-03-11

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• Los Angeles General Medical Center — Los Angeles, California, United States (enrolling)
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Minnesota - Masonic Cancer Center — Minneapolis, Minnesota, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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