RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-03-11
Study Completion:2026-03-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03858205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic diagnosis of multiple myeloma
  2. * Painful bone metastasis (index lesion) that has a radiographic correlate
  3. * 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)
  4. * Eastern Cooperative Oncology Group (ECOG) 0-2
  5. * Brief Pain Inventory (BPI) score \>= 2
  6. * Ability to understand and the willingness to sign a written informed consent
  1. * 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
  2. * 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
  3. * 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
  4. * Patients must not be pregnant

Contacts and Locations

Study Contact

Christine Duran
CONTACT
323-865-0371
Duran_C@med.usc.edu

Principal Investigator

Adam Garsa, MD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Los Angeles General Medical Center
Los Angeles, California, 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Minnesota - Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Adam Garsa, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-11
Study Completion Date2026-03-11

Study Record Updates

Study Start Date2019-03-11
Study Completion Date2026-03-11

Terms related to this study

Additional Relevant MeSH Terms

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