Low-dose radiotherapy for painful bone metastases in multiple myeloma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.