Actively Recruiting
Phase II Multi-Institutional Study of Low-Dose (2Gy) Palliative Radiotherapy for Painful Bone Metastases in Multiple Myeloma
Led by University of Southern California · Updated on 2026-06-05
100
Participants Needed
9
Research Sites
10 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating low-dose radiotherapy to treat bone pain in patients with multiple myeloma that has spread to the bones. This Phase II trial aims to see if a lower dose radiation treatment can reduce pain as effectively as the current standard care, while potentially being more convenient and causing fewer short- or long-term side effects. The study also looks at quality of life and pain medication use after treatment. Participants receive low-dose radiation therapy of 2 Gy on two consecutive business days. If patients do not experience pain relief, they may receive additional radiotherapy four weeks later. After treatment, patients are followed up at 2, 4, and 8 weeks, and again at 6 months to monitor outcomes and any changes. During the study, patients will be assessed for pain relief using patient reports and questionnaires that measure quality of life. Researchers will also track pain medication use and monitor any side effects or disease progression. The main outcome is pain response up to six months after radiation therapy. The total participation duration includes treatment and follow-up visits over six months.
CONDITIONS
Brief Title
Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of multiple myeloma
- Painful bone metastasis with a radiographic correlate
- Any number of prior chemotherapy or immunotherapy treatments allowed
- ECOG performance status of 0 to 2
- Brief Pain Inventory score of 2 or higher
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Prior radiation therapy or palliative surgery at the index lesion
- Pathologic or impending fracture at the index lesion site or planned surgical fixation
- Evidence of spinal cord or cauda equina compression from the index lesion
- Index lesions located at the skull base or orbital areas
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial treatment over 2 consecutive days; additional treatment possible at 4 weeks
Participants receive low-dose radiation therapy at consecutive business days 1 and 2. If pain relief is not achieved, additional radiotherapy may be given at 4 weeks after initial treatment.
2 consecutive visits followed by 1 additional visit at 4 weeks if needed
Duration - Up to 6 months
Participants are followed up to monitor pain response, quality of life, and analgesia use at 2, 4, and 8 weeks and 6 months after radiation therapy completion.
Visits at 2, 4, and 8 weeks and at 6 months
Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
University of Minnesota - Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Christine Duran
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here