Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Radiation Therapy
RadiationReceive low-dose radiation therapy
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Treatment (low-dose radiation therapy)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pain response
Pain will be measured using the Brief Pain Inventory (BPI).
Time frame
Up to 6 months after completion of radiation therapySecondary outcomes
1
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.
Time frame
Up to 6 months after completion of radiation therapy2
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.
Time frame
Up to 6 months after completion of radiation therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov