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

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Feb 26, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how effective low-dose radiotherapy is for treating pain caused by bone metastases in patients with multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells in the bone, and when it spreads, it can cause significant pain. The trial aims to see if using a lower dose of radiation can help relieve this pain while being more convenient for patients and their families, potentially leading to fewer side effects and less interference with other treatments like chemotherapy.

To participate in the trial, patients need to have a confirmed diagnosis of multiple myeloma and painful bone metastases that can be seen on imaging tests. They should also be able to understand the study and provide written consent. While the trial is open to many patients, those who have received prior radiation therapy on the painful area, have certain types of fractures, or are pregnant will not be eligible. Participants can expect to receive low-dose radiation treatment and will be monitored for its effects on their pain and overall health.

Gender

ALL

Eligibility criteria

• 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 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