100 Participants Needed

Low-Dose Radiotherapy for Multiple Myeloma with Bone Pain

Recruiting at 9 trial locations
CD
Overseen ByChristine Duran
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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.12345

Is 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.12678

How 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.1291011

Research Team

AG

Adam Garsa, MD

Principal Investigator

University of Southern California

Eligibility 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
See 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.
See 1 more

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

Treatment Details

Interventions

  • Low-Dose Radiotherapy
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 29 patients with multiple myeloma, radiation therapy provided significant symptomatic relief, achieving remission in 92% of painful lesions and 75% of neurological abnormalities, indicating its effectiveness as a palliative treatment.
The study suggests that higher total radiation doses (median 40 Gy) may be necessary for adequate pain relief, with complete relief observed at a median total dose of 66 Gy, which is higher than the previously reported effective range of 10 to 20 Gy.
[Palliative radiation therapy for multiple myeloma].Minowa, Y., Sasai, K., Ishigaki, T., et al.[2011]
In a study of 88 patients with multiple myeloma treated with palliative radiation, 83% experienced symptomatic relief from pain, indicating that radiation can effectively alleviate discomfort in these patients.
Radiographic responses were less favorable, with only 13% showing complete response and 16% partial response, suggesting that while patients may feel better, the imaging results do not always reflect clinical improvement.
Local Radiation Therapy for Palliation in Patients With Multiple Myeloma of the Spine.Mark, D., Gilbo, P., Meshrekey, R., et al.[2020]
External beam radiotherapy effectively manages pain from bone metastases, including cases of spinal canal compression and pathological fractures, potentially preventing further complications.
Single-dose radiotherapy is a highly cost-effective palliative treatment option for patients with bone metastases, making it a practical choice for pain management.
The role of external beam radiotherapy in the management of bone metastases.Agarawal, JP., Swangsilpa, T., van der Linden, Y., et al.[2022]

References

[Palliative radiation therapy for multiple myeloma]. [2011]
Local Radiation Therapy for Palliation in Patients With Multiple Myeloma of the Spine. [2020]
The role of external beam radiotherapy in the management of bone metastases. [2022]
A systematic overview of radiation therapy effects in skeletal metastases. [2022]
Radiation therapy in multiple myeloma. [2004]
[Conformal radiotherapy for vertebral bone metastasis]. [2017]
Radiation therapy for the palliation of multiple myeloma. [2022]
Radiotherapy of Bone Metastasis in Breast Cancer Patients - Current Approaches. [2022]
[Role of radiotherapy in the treatment of multiple myeloma]. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Effective Pain Control With Very Low Dose Palliative Radiation Therapy for Patients With Multiple Myeloma With Uncomplicated Osseous Lesions. [2021]
The impact of one fraction of 8 Gy radiotherapy in palliative treatment of multiple myeloma patients with painful bone destructions. [2022]