Low-dose radiotherapy for painful bone metastases in multiple myeloma patients
Phase II Multi-Institutional Study of Low-Dose (2Gy) Palliative Radiotherapy in the Treatment of Symptomatic Bone Metastases From Multiple Myeloma
This study is testing if low-dose radiation therapy can help reduce bone pain in patients with multiple myeloma that has spread to their bones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 9 sites (Duarte, California and 8 other locations) |
| Trial ID | NCT03858205 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of low-dose radiotherapy in alleviating bone pain caused by multiple myeloma that has metastasized to the bone. Patients will receive radiation therapy in two doses of 2 Gy on consecutive days, and their pain levels will be assessed at four weeks to determine if this treatment provides comparable pain relief to standard care. Secondary objectives include measuring quality of life, analgesic use, and the duration of pain relief. Participants will be monitored for pain relief and any side effects over a follow-up period of six months.
Who should consider this trial
Good fit: Ideal candidates are patients with a histologic diagnosis of multiple myeloma and painful bone metastases that have a radiographic correlate.
Not a fit: Patients who have previously received radiation therapy to the index lesion or have a pathologic fracture may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from bone metastases due to multiple myeloma with fewer side effects than traditional therapies.
How similar studies have performed: Other studies have shown promise with low-dose radiotherapy for pain management in similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California and 8 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Los Angeles General Medical Center — Los Angeles, California, United States (Recruiting)
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- University of Minnesota - Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Adam Garsa, MD — University of Southern California
- Study coordinator: Christine Duran
- Email: Duran_C@med.usc.edu
- Phone: 323-865-0371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.