Low-Dose Radiotherapy for Multiple Myeloma with Bone Pain
Recruiting in Palo Alto (17 mi)
+9 other locations
Overseen byAdam Garsa, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Southern California
Disqualifiers: Prior radiation, Fracture, Spinal compression, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it allows changes to systemic therapy or use of bisphosphonates (medications that prevent bone loss) for 4 weeks before and after the radiation therapy.
What data supports the effectiveness of the treatment Low-Dose Radiotherapy for Multiple Myeloma with Bone Pain?
Research shows that radiation therapy can provide pain relief for patients with multiple myeloma, with studies indicating that 81% of cases experience pain relief. Additionally, radiation therapy is effective in managing bone pain from metastases, with more than 80% of patients experiencing pain relief.
12345Is low-dose radiotherapy safe for humans?
Low-dose radiotherapy, used for conditions like multiple myeloma and bone metastases, is generally considered safe for humans. Common side effects may include nausea and a decrease in blood cell counts, which require monitoring, but it is effective in providing pain relief.
12678How does low-dose radiotherapy differ from other treatments for multiple myeloma with bone pain?
Low-dose radiotherapy is unique because it uses smaller doses of radiation to relieve bone pain in multiple myeloma patients, focusing on symptom relief rather than curing the disease. This approach is particularly beneficial for patients with uncomplicated bone lesions, offering effective pain control with potentially fewer side effects compared to higher-dose treatments.
1291011Eligibility Criteria
This trial is for patients with multiple myeloma and painful bone metastases. Participants must have a pain score of at least 2, confirmed diagnosis, and be able to consent. They can have had any number of prior treatments but should not be pregnant or have received radiation on the index lesion.Inclusion Criteria
You have significant pain, rated 2 or higher on a pain scale.
I may have had any number of previous cancer treatments, but changes must be recorded.
Ability to understand and the willingness to sign a written informed consent
+3 more
Exclusion Criteria
My main tumor was treated with radiation or surgery for symptom relief.
Pregnancy
I have a broken bone or one that might break where my cancer is or I need surgery to fix a bone where my cancer is.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive low-dose radiation therapy at consecutive business days 1 and 2
1 week
2 visits (in-person)
Follow-up
Participants are monitored for pain relief and quality of life after radiation therapy
6 months
Follow-up visits at 2, 4, and 8 weeks and at 6 months
Participant Groups
The study is examining the effectiveness of low-dose radiotherapy in alleviating bone pain caused by multiple myeloma that has spread to bones. It aims to see if this approach is more convenient and results in fewer side effects than traditional doses.
1Treatment groups
Experimental Treatment
Group I: Treatment (low-dose radiation therapy)Experimental Treatment3 Interventions
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.
Low-Dose Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Low-Dose Radiotherapy for:
- Painful bone metastases from multiple myeloma
- Symptomatic relief of bone pain
🇺🇸 Approved in United States as Low-Dose Radiotherapy for:
- Painful bone metastases from multiple myeloma
- Symptomatic relief of bone pain
- Spinal cord compression
🇨🇦 Approved in Canada as Low-Dose Radiotherapy for:
- Painful bone metastases from multiple myeloma
- Symptomatic relief of bone pain
🇯🇵 Approved in Japan as Low-Dose Radiotherapy for:
- Painful bone metastases from multiple myeloma
- Symptomatic relief of bone pain
🇨🇳 Approved in China as Low-Dose Radiotherapy for:
- Painful bone metastases from multiple myeloma
- Symptomatic relief of bone pain
🇨🇭 Approved in Switzerland as Low-Dose Radiotherapy for:
- Painful bone metastases from multiple myeloma
- Symptomatic relief of bone pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Los Angeles County-USC Medical CenterLos Angeles, CA
Dana-Farber Cancer InstituteBoston, MA
USC / Norris Comprehensive Cancer CenterLos Angeles, CA
Cedars Sinai Medical CenterLos Angeles, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
[Palliative radiation therapy for multiple myeloma]. [2011]Radiation therapy is a useful palliative modality for refractory lesions of multiple myeloma. It has been reported that total doses of 10 to 20 Gy are usually adequate to obtain some degree of pain relief. However, there are many patients who need additional doses to obtain sufficient pain relief. In this study, we retrospectively analyzed the records of patients with multiple myeloma irradiated at our department, in an attempt to develop an effective treatment policy for this disease.
Local Radiation Therapy for Palliation in Patients With Multiple Myeloma of the Spine. [2020]Purpose: The objective of this study was to assess a contemporary cohort of patients with multiple myeloma referred for palliative radiation to the mobile spine for clinical and radiological responses. Materials/Methods: The records of patients treated between 2009 and 2016 with radiotherapy for multiple myeloma of the spine were retrospectively reviewed. Demographics, systemic therapy, radiation dose, number of fractions, radiographic response based upon adapted RECIST criteria, and symptomatic response were recorded. Results: Eighty eight patients and 98 treatment courses were analyzed. All courses were analyzed for symptomatic response and 61 of the treatment courses were available for radiologic follow-up. The median follow-up was 9.7 months with a median radiation dose of 25 Gy (12.5-50 Gy) delivered in a median of 10 fractions (5-25 fractions). Fifty-four percent of patients had a high-risk lesion. Symptomatic response as measured by a decrease of ≤5 points on the pain related scale was 83% and 34% of patients had a decrease of >5 points. Of 35% of patients that had neurologic impairments prior to treatment, improvement was identified 83% of the time. Radiographic response was noted as 13% complete response, 16% partial response, 57% stable disease, and 13% disease progression. Specifically, high-risk lesions treated with radiation alone demonstrated no regression with only 10% demonstrating partial response. Conclusion: This retrospective series of patients treated with palliative intent for multiple myeloma using various dose and fractionation schemes showed favorable symptomatic relief in most patients. Radiographic response did not correlate with clinical response with fewer patients having radiologic disease regression. Longer follow-up is necessary to determine if the lack of radiologic response is associated with clinically relevant recurrent pain.
The role of external beam radiotherapy in the management of bone metastases. [2022]External beam radiotherapy is effective in the management of bone metastases for both local and more widespread pain. It is effective in spinal canal compression and pathological fracture where it also may have a prophylactic role. Single dose radiotherapy for bone metastases is a highly cost effective palliative treatment.
A systematic overview of radiation therapy effects in skeletal metastases. [2022]A systematic review of radiation therapy trials in several tumour types was performed by The Swedish Council of Technology Assessment in Health Care (SBU). The procedures for evaluation of the scientific literature are described separately (Acta Oncol 2003; 42: 357-365). This synthesis of the literature on radiation therapy for skeletal metastases is based on data from 16 randomized trials. Moreover, data from 20 prospective studies, 5 retrospective studies and 22 other articles were used. A total of 63 scientific articles are included, involving 8051 patients. The results were compared with those of a similar overview from 1996 including 13,054 patients. The conclusions reached can be summarized as follows: Irradiation of skeletal metastases is, with few exceptions, a palliative treatment. There is strong evidence that radiotherapy of skeletal metastases gives an overall (complete and partial pain relief) in more than 80% of patients. There is strong evidence that the duration of pain relief in at least 50% of patients lasts for > or = 6 months. There is convincing evidence that pain relief, in terms of degree and duration, does not depend on the fractionation schedules applied. Irrespective of the fractionation schedule used at irradiation, the number of later complications, such as spinal cord compression or pathological fractures, at the index fields are low. There are some data showing that the difference in cost between single and multifraction treatment is small. However, these data do not permit any firm conclusions to be drawn. Several reports indicate that early diagnosis and early therapy of spinal cord compression are the two most important predictors of a favourable clinical outcome after radiotherapy. However, no controlled studies have been undertaken. When the diagnosis of spinal cord compression is late, a favourable outcome might depend on the radio-responsiveness of the tumour. The documentation is weak and no conclusions can be drawn. There is some evidence that a small proportion of totally paralytic patients can regain walking function after radiotherapy. There is strong evidence that the radionuclides 89Sr and 153Sm are efficient when they are used as a systemic treatment of generalized bone pain due to metastasis from carcinomas of the prostate and breast. Overall bone pain relief occurs in about 60-80% of patients with a median response duration of 2-4 months. There is strong evidence that intravenous treatment with bisphosphonates in patients with myeloma and osteolytic bone metastasis due to carcinoma of the breast significantly decreases the number of skeleton-related events and bone pain.
Radiation therapy in multiple myeloma. [2004]In this retrospective study of 76 patients with myeloma, the indications for radiation therapy are reviewed and its value analyzed. Eleven patients presented with a "solitary plasmacytoma" and 65 patients presented with disseminated disease. Radiation therapy is successful in both the palliation of pain (81% of cases) and in producing long-term remission and possibly cure in solitary lesions.
[Conformal radiotherapy for vertebral bone metastasis]. [2017]Analgesic external beam radiation therapy is a standard of care for patients with uncomplicated painful bone metastases and/or prevention of bone complications. In case of fracture risk, radiation therapy is performed after surgery in a consolidation of an analgesic purpose and stabilizing osteosynthesis. Radiotherapy is mandatory after vertebroplasty or kyphoplasty. Spinal cord compression - the only emergency in radiation therapy - is indicated postoperatively either exclusively for non surgical indication. Analgesic re-irradiation is possible in the case of insufficient response or recurrent pain after radiotherapy. Metabolic radiation, bisphosphonates or denosumab do not dissuade external radiation therapy for pain relief. Systemic oncological treatments can be suspended with a period of wash out given the risk of radiosensitization or recall phenomenon. Better yet, the intensity modulated radiotherapy and stereotactic radiotherapy can be part of a curative strategy for oligometastatic patients and suggest new treatment prospects.
Radiation therapy for the palliation of multiple myeloma. [2022]This reviews the experience at the University of Arizona in an effort to define the minimum effective radiation dose for durable pain relief in the majority of patients with symptomatic multiple myeloma.
Radiotherapy of Bone Metastasis in Breast Cancer Patients - Current Approaches. [2022]Bone metastases (BM) represent the most frequent indication for palliative radiotherapy in patients with breast cancer. BM increase the risk of skeletal-related events defined as pathological fractures, spinal cord compression, and, most frequently, bone pain. The therapeutic goals of palliative radiotherapy for BM are pain relief, recalcification, and stabilization, reducing spinal cord compression and minimizing the risk of paraplegia. In advanced tumor stages radiotherapy may also be used to alleviate symptoms of generalized bone metastasis. This requires an individual approach including factors, such as life expectancy and tumor progression at different sites. Side effects of radiation therapy of the middle and lower spine may include nausea and emesis requiring adequate antiemetic prophylaxis. Irradiation of large bone marrow areas may cause myelotoxicity making monitoring of blood cell counts mandatory. Radiotherapy is an effective tool in palliation treatment of BM and is part of an interdisciplinary approach. Preferred technique, targeting, and different dose schedules are described in the guidelines of the German Society for Radiooncology (DEGRO) which are also integrated in 2012 recommendations of the Working Group Gynecologic Oncology (AGO).
[Role of radiotherapy in the treatment of multiple myeloma]. [2019]Chemotherapy is the treatment of choice in multiple myeloma; but there are no curative options. Therefore, the treatment rationale is characterized by reduction of symptoms and inhibition of complications. Regarding reduction of pain, treatment of (impending) fractures, and spinal cord compression radiation is an important part of palliative treatment. In our retrospective study we report the effect of radiotherapy on reduction of pain, recalcification and the reduction of neurological symptoms and evaluate factors which have an impact on therapeutic outcome.
Effective Pain Control With Very Low Dose Palliative Radiation Therapy for Patients With Multiple Myeloma With Uncomplicated Osseous Lesions. [2021]Osteolytic lesions are present in 75% of patients with multiple myeloma (MM) and frequently require palliation with radiation therapy (RT). Prior case series of patients with MM with bone pain undergoing palliative RT suggests doses ≥12 Gy (equivalent dose in 2Gy fractions, EQD2) provide excellent bone pain relief. However, recent advances in care and novel biologic agents have significantly improved overall survival and quality of life for patients with MM. We hypothesized that lower-dose RT (LDRT, EQD2
The impact of one fraction of 8 Gy radiotherapy in palliative treatment of multiple myeloma patients with painful bone destructions. [2022]Radiotherapy is required to overcome pain and to promote recalcification in multiple myeloma (MM) patients. The aim of our prospective study was to evaluate the impact of one fraction of 8 Gy regimen in palliative treatment of MM.