Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma LOW-DOSE RADIOTHERAPY FOR BONE METASTASES

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?


I. To determine whether treatment with 2 Gy x 2 to a painful myeloma bone lesion achieves patient-reported pain reduction comparable to current standard of care at 4 weeks.


I. To assess quality of life (QOL) in patients treated with 2 Gy x 2 to painful myeloma bone lesions.

II. To quantify analgesia use/reduction following 2 Gy x 2 to a painful myeloma bone lesion. All opioid analgesia use will be converted into morphine equivalent in order to compare across the entire population.

III. To measure time to pain relief and duration of pain relief with 2 Gy x 2.


I. To record cytogenetics and International Myeloma Working Group (IMWG) response criteria at diagnosis and prior to and following radiotherapy (RT).


Patients receive low-dose radiation therapy at consecutive business days 1 and 2 in the absence of disease progression or unacceptable toxicity. Patients with no pain relief may receive additional radiotherapy at 4 weeks following initial radiotherapy.

After completion of study treatment, patients are followed up at 2, 4, and 8 weeks and also at 6 months.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 2

Enrollment: 100 patients (estimated)

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Trial Locations

All Trial Locations

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City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

LAC + USC Medical Center

Los Angeles, CA

Open and Accepting


Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting


Dana-Farber Cancer Institute (Main)

Boston, MA

Open and Accepting


University of Minnesota - Masonic Cancer Center

Minneapolis, MN

Open and Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting


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