NCT03858205 Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
| NCT ID | NCT03858205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern California |
| Condition | Bone Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-03-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2019-03-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Adam Garsa, MD
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT03858205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03858205 currently recruiting?
Yes, NCT03858205 is actively recruiting participants. Contact the research team at Duran_C@med.usc.edu for enrollment information.
Where is the NCT03858205 trial being conducted?
This trial is being conducted at Duarte, United States, Los Angeles, United States, Los Angeles, United States, Los Angeles, United States and 5 additional locations.
Who is sponsoring the NCT03858205 clinical trial?
NCT03858205 is sponsored by University of Southern California. The principal investigator is Adam Garsa, MD at University of Southern California. The trial plans to enroll 100 participants.