Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT03858205 |
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Recruitment Status :
Recruiting
First Posted : February 28, 2019
Last Update Posted : March 2, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bone Pain Metastatic Malignant Neoplasm in the Bone Plasma Cell Myeloma | Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Multi-Institutional Study of Low-Dose (2Gy x 2) Palliative Radiotherapy in the Treatment of Symptomatic Bone Metastases From Multiple Myeloma |
| Actual Study Start Date : | March 11, 2019 |
| Estimated Primary Completion Date : | March 11, 2023 |
| Estimated Study Completion Date : | March 11, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies Radiation: Radiation Therapy Receive low-dose radiation therapy
Other Names:
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- Pain response [ Time Frame: Up to 6 months after completion of radiation therapy ]Pain will be measured using the Brief Pain Inventory (BPI).
- Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22) [ Time Frame: Up to 6 months after completion of radiation therapy ]
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.
- Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Up to 6 months after completion of radiation therapy ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858205
| Contact: Christine Duran | 323-865-0371 | Duran_C@med.usc.edu |
| United States, California | |
| City of Hope | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Bianca Del Vecchio 626-218-4402 bdelvecchio@coh.org | |
| Principal Investigator: Savita V Dandapani, MD | |
| Los Angeles County-USC Medical Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Donna Fernando, RN 323-409-4388 Donna.fernando@med.usc.edu | |
| Principal Investigator: Leslie Ballas, MD | |
| USC / Norris Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Donna Fernando, RN 323-409-4388 Donna.fernando@med.usc.edu | |
| Principal Investigator: Leslie Ballas, MD | |
| United States, Georgia | |
| Emory University Hospital/Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Mohammad K. Khan 404-778-3473 Drkhurram2000@gmail.com | |
| Principal Investigator: Mohammad K. Khan | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Patrick Boyle 617-582-8918 PJBoyle@dfci.harvard.edu | |
| Contact: Carol Mayo 508-488-3800 CMAYO@PARTNERS.ORG | |
| Principal Investigator: Andrea K. Ng | |
| United States, Minnesota | |
| University of Minnesota - Masonic Cancer Center | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Kate Bak 612-301-0151 kbak@umn.edu | |
| Principal Investigator: Stephanie Terezakis, MD | |
| United States, New York | |
| Icahn School of Medicine at Mount Sinai | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Richard L. Bakst 212-241-3545 Richard.bakst@mtsinai.org | |
| Principal Investigator: Richard L. Bakst | |
| United States, Pennsylvania | |
| University of Pennsylvania/Abramson Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Dave Farraday 215-662-2709 dfarrady@pennmedicine.upenn.edu | |
| Contact: Kelly Farraday 215-349-8594 kellyfar@pennmedicine.upenn.edu | |
| Principal Investigator: Ima Paydar, MD | |
| Principal Investigator: | Leslie Ballas, MD | University of Southern California |
| Responsible Party: | University of Southern California |
| ClinicalTrials.gov Identifier: | NCT03858205 |
| Other Study ID Numbers: |
16M-18-2 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 ) |
| First Posted: | February 28, 2019 Key Record Dates |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | February 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |