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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03858205
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Southern California
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Adam Garsa, MD
Principal Investigator Affiliation University of Southern California
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Bone Pain, Metastatic Malignant Neoplasm in the Bone, Plasma Cell Myeloma
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Questionnaire Administration

Ancillary studies

Radiation: - Radiation Therapy

Receive low-dose radiation therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

Site Contact

Bianca Del Vecchio

bdelvecchio@coh.org

626-218-4402

Los Angeles General Medical Center, Los Angeles, California

Status

Recruiting

Address

Los Angeles General Medical Center

Los Angeles, California, 90033

Site Contact

Donna Fernando, RN

Donna.fernando@med.usc.edu

323-409-4388

USC / Norris Comprehensive Cancer Center, Los Angeles, California

Status

Recruiting

Address

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Site Contact

Donna Fernando, RN

Donna.fernando@med.usc.edu

323-409-4388

Cedars Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Chace Henning

chace.henning@cshs.org

310-423-8218

Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Site Contact

Mohammad K. Khan

Drkhurram2000@gmail.com

404-778-3473

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Patrick Boyle

PJBoyle@dfci.harvard.edu

617-582-8918

Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota - Masonic Cancer Center

Minneapolis, Minnesota, 55455

Site Contact

Kate Bak

kbak@umn.edu

612-301-0151

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Richard L. Bakst

Richard.bakst@mtsinai.org

212-241-3545

Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Site Contact

Dave Farraday

dfarrady@pennmedicine.upenn.edu

215-662-2709