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

Active:	Yes
Cancer Type:	Bone Tumor Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT03858205
Trial Phases:	Phase II	Protocol IDs:	16M-18-2 (primary) NCI-2018-03600
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	USC / Norris Comprehensive Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03858205

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.

Objectives

PRIMARY OBJECTIVES:
I. To determine whether treatment with 4 Gy to a painful myeloma bone lesion achieves patient-reported pain reduction comparable to historical controls at 4 weeks.
SECONDARY OBJECTIVES:
I. To assess quality of life (QOL) in patients treated with 4 Gy to painful myeloma bone lesions.
II. To quantify analgesia use/reduction following 4 Gy 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 4 Gy.
IV. To assess pain relief in patients with more than 1 index lesion.

EXPLORATORY OBJECTIVES:
I. To record cytogenetics and International Myeloma Working Group (IMWG) response criteria at diagnosis and prior to and following radiotherapy (RT).
II. To evaluate pain response at index lesion after the 2nd course of radiation (reirradiation), if required.

OUTLINE:
Patients receive low-dose radiation therapy on study. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.