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

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.

Study Overview

• Status: Recruiting
• Conditions: Plasma Cell Myeloma; Metastatic Malignant Neoplasm in the Bone; Bone Pain
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Duran; Phone Number: 323-865-0371; Email: Duran_C@med.usc.edu

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
      • Contact: Bianca Del Vecchio; Phone Number: 626-218-4402; Email: bdelvecchio@coh.org
      • Principal Investigator: Savita V Dandapani, MD
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
      • Principal Investigator: Leslie Ballas, MD
      • Contact: Chace Henning; Phone Number: 310-423-8218; Email: chace.henning@cshs.org
      • Contact: Harpavan Sandha; Phone Number: 310-423-4849; Email: harpavan.sandha@cshs.org
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Contact: Donna Fernando, RN; Phone Number: 323-409-4388; Email: Donna.fernando@med.usc.edu
      • Principal Investigator: Adam Garsa, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Los Angeles General Medical Center
      • Contact: Donna Fernando, RN; Phone Number: 323-409-4388; Email: Donna.fernando@med.usc.edu
      • Principal Investigator: Adam Garsa, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital/Winship Cancer Institute
      • Contact: Mohammad K. Khan; Phone Number: 404-778-3473; Email: Drkhurram2000@gmail.com
      • Principal Investigator: Mohammad K. Khan
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Patrick Boyle; Phone Number: 617-582-8918; Email: PJBoyle@dfci.harvard.edu
      • Contact: Carol Mayo; Phone Number: 508-488-3800; Email: CMAYO@PARTNERS.ORG
      • Principal Investigator: Andrea K. Ng
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota - Masonic Cancer Center
      • Contact: Kate Bak; Phone Number: 612-301-0151; Email: kbak@umn.edu
      • Principal Investigator: Stephanie Terezakis, MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Richard L. Bakst; Phone Number: 212-241-3545; Email: Richard.bakst@mtsinai.org
      • Principal Investigator: Richard L. Bakst
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania/Abramson Cancer Center
      • Contact: Jhohanna Perez; Phone Number: 267-299-9643; Email: RadOncCRU@PennMedicine.upenn.edu
      • Principal Investigator: John Plastaras, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (low-dose radiation therapy); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Radiation: Radiation Therapy; Receive low-dose radiation therapy; Other Names: Cancer Radiotherapy; Irradiate; Irradiated; Radiation; Radiotherapeutics; RT; Therapy, Radiation; irradiation; RADIOTHERAPY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain response	Pain will be measured using the Brief Pain Inventory (BPI).	Up to 6 months after completion of radiation therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)	Quality of life will be assessed before and after radiation therapy. EORTC QLQ-BM22 measures four multi-item scales: painful sites, functional interference, painful characteristics, and psychosocial aspects. Each item will be scaled as: 1= not at all; 2 = a little; 3 = quite a bit; 4 =very much. Answers will be converted into grading scale, with values between 0 and 100. Higher scores represent worse QOL for the subscales of painful sites, painful characteristics and psychosocial aspects, while higher scores in functional scale represents better functioning.	Up to 6 months after completion of radiation therapy
Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC QLQ-C30)	The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures including functional scales, symptom scales, a global health status / QoL scale, and single item measures. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	Up to 6 months after completion of radiation therapy

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Adam Garsa, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 11, 2027

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Therapeutics; Physical Phenomena; Radiotherapy; Radiation
• Other Study ID Numbers: 16M-18-2 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2018-03600 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No