Status:
RECRUITING
Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bone Pain
Metastatic Malignant Neoplasm in the Bone
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 r...
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. SECON...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 11 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03858205
Start Date
March 11 2019
End Date
March 11 2027
Last Update
July 11 2025
Active Locations (9)
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1
City of Hope
Duarte, California, United States, 91010
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048