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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-03600 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 16M-18-2 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Duran | Contact | 323-865-0371 | Duran_C@med.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adam Garsa, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| Questionnaire Administration | Other | Ancillary studies |
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| Radiation Therapy | Radiation | Receive low-dose radiation therapy |
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| 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 |
| Los Angeles General Medical Center | Recruiting | Los Angeles | California | 90033 | United States |
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| USC / Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
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| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Minnesota - Masonic Cancer Center | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| University of Pennsylvania/Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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