NCT03858205

Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. EXPLORATORY OBJECTIVES: I. To record cytogenetics and International Myeloma Working Group (IMWG) response criteria at diagnosis and prior to and following radiotherapy (RT). OUTLINE: 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.

Conditions

• Bone Pain
• Metastatic Malignant Neoplasm in the Bone
• Plasma Cell Myeloma

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Receive low-dose radiation therapy

Timeline

• Start date: 2019-03-11
• Primary completion: 2026-03-11
• Completion: 2027-03-11
• First posted: 2019-02-28
• Last updated: 2025-07-11

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study