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

Trial Status: Active

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.

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Bianca Del Vecchio
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Leslie Ballas
Phone: 323-865-3050
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Leslie Ballas
Phone: 323-865-3050

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Mohammad Khurram Khan
Phone: 404-778-3473

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Andrea Ka-Min Ng
Phone: 617-632-3400
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Chirayu Patel
Milford
Dana-Farber / Brigham and Women's Cancer Center at Milford Regional
Status: ACTIVE
Contact: Monica S. Krishnan
South Weymouth
Dana-Farber / Brigham and Women's Cancer Center at South Shore
Status: ACTIVE
Contact: Ron Y. Shiloh

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Contact: Richard L. Bakst
Phone: 212-241-3545

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Alireza Fotouhi Ghiam
Phone: 215-615-0559

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
USC / Norris Comprehensive Cancer Center

Principal Investigator
Leslie Ballas

  • Primary ID 16M-18-2
  • Secondary IDs NCI-2018-03600
  • Clinicaltrials.gov ID NCT03858205