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Back|NCT03858205Recruiting
Official Title

Phase II Multi-Institutional Study of Low-Dose (2Gy) Palliative Radiotherapy in the Treatment of Symptomatic Bone Metastases From Multiple Myeloma

Sponsor
University of Southern California
Enrollment
100
Timeline
Mar 2019 → Mar 2027
About This Study

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

  • 1Histologic diagnosis of multiple myeloma
  • 2Painful bone metastasis (index lesion) that has a radiographic correlate
  • 3Patient 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)
  • 4Eastern Cooperative Oncology Group (ECOG) 0-2
  • 5Brief Pain Inventory (BPI) score \>= 2
  • 6Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

  • 1Patients 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
  • 2Patients 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
  • 3Patients 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
  • 4Patients must not be pregnant

Locations

9 sites participating in this study

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Mohammad K. Khan

City of Hope

Duarte, California 91010

Recruiting

Savita V Dandapani, MD

Los Angeles General Medical Center

Los Angeles, California 90033

Recruiting

Adam Garsa, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →