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

NCT03858205 | Recruiting DMC FDA Device

• 3 other identifiers: 16M-18-2NCI-2018-03600P30CA014089
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pain response

  Pain will be measured using the Brief Pain Inventory (BPI).

  Up to 6 months after completion of radiation therapy

Secondary Outcomes (2)

• Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)

  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)

  Up to 6 months after completion of radiation therapy

Study Arms (1)

Treatment (low-dose radiation therapy)

EXPERIMENTAL

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; Other: Questionnaire Administration; Radiation: Radiation Therapy

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (low-dose radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (low-dose radiation therapy)

Radiation Therapy RADIATION

Receive low-dose radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Treatment (low-dose radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Minnesota - Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Adam Garsa, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Duran

CONTACT

323-865-0371; Duran_C@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 28, 2019
• Study Start: March 11, 2019
• Primary Completion: March 11, 2026
• Study Completion (Estimated): March 11, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (9)