Low-Dose Radiotherapy for Bone Metastases

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

What will happen during the trial?

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.

More Information

Trial Status
Accepting patients
Trial Phase
Phase 2
Enrollment
100 patients (estimated)
Sponsors
USC Norris Comprehensive Cancer Center - Keck School of Medicine
Collaborators
National Cancer Institute (NCI)
Tags
Radiation Therapy
Trial Type
Supportive
Last Update
2 weeks ago
SparkCures ID
1196
NCT Identifier
NCT03858205

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