Low-Dose Radiotherapy for Multiple Myeloma with Bone Pain

Recruiting at 9 trial locations

Overseen By Christine Duran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Prior radiation, Fracture, Spinal compression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 2 9 10 11}

Research Team

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

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.

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 Overview 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.

Participant Groups

Group I: Treatment (low-dose radiation therapy) Experimental Treatment 3 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of external beam radiotherapy in the management of bone metastases. Agarawal, JP., Swangsilpa, T., van der Linden, Y., et al.[2022]

Radiation therapy for skeletal metastases provides significant pain relief, with over 80% of patients experiencing complete or partial relief, and at least 50% of patients maintaining this relief for more than 6 months.

The treatment's effectiveness and duration of pain relief are not influenced by the fractionation schedules used, and complications such as spinal cord compression or fractures are low, making it a safe palliative option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic overview of radiation therapy effects in skeletal metastases. Falkmer, U., Järhult, J., Wersäll, P., et al.[2022]

In a study of 76 myeloma patients, radiation therapy effectively alleviated pain in 81% of cases, demonstrating its efficacy in palliative care.

Radiation therapy was particularly valuable for patients with solitary plasmacytomas, leading to long-term remission and potential cures, highlighting its role in targeted treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy in multiple myeloma. Mill, WB.[2004]

Analgesic external beam radiation therapy is an effective standard treatment for managing pain from bone metastases and is crucial for preventing complications, especially after surgeries like vertebroplasty or kyphoplasty.

Advanced techniques like intensity-modulated radiotherapy and stereotactic radiotherapy may offer curative options for patients with oligometastatic disease, expanding treatment possibilities beyond just pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conformal radiotherapy for vertebral bone metastasis]. Faivre, JC., Py, JF., Vogin, G., et al.[2017]

In a review of 101 patients with multiple myeloma, radiation therapy provided significant pain relief, with 97% of symptomatic sites showing improvement after treatment, regardless of the radiation dose.

A total radiation dose of 10 Gy was found to be effective for durable symptom relief in most patients, indicating that lower doses can still achieve significant palliative effects without a clear dose-response relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy for the palliation of multiple myeloma. Leigh, BR., Kurtts, TA., Mack, CF., et al.[2022]

Palliative radiotherapy is an effective treatment for bone metastases in breast cancer patients, primarily aimed at relieving pain, stabilizing bone structure, and preventing complications like spinal cord compression.

The treatment requires careful consideration of individual patient factors, such as life expectancy and tumor progression, and may have side effects like nausea and myelotoxicity, necessitating monitoring and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy of Bone Metastasis in Breast Cancer Patients - Current Approaches. Feyer, PC., Steingraeber, M.[2022]

In a retrospective study of 42 patients with multiple myeloma, radiotherapy provided complete or partial pain relief in 85% of cases, demonstrating its effectiveness as a palliative treatment for managing symptoms like bone pain and spinal cord compression.

Factors such as a Karnofsky performance status of 70% or higher and simultaneous chemotherapy significantly improved treatment responses, although radiotherapy did not affect overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of radiotherapy in the treatment of multiple myeloma]. Mose, S., Pfitzner, D., Rahn, A., et al.[2019]

Lower-dose radiation therapy (LDRT) with doses less than 12 Gy provided effective pain relief for patients with multiple myeloma (MM), achieving a clinical pain response (CPR) rate of 95%, which is comparable to the 98% CPR rate seen with higher-dose radiation therapy (HDRT) of 12 Gy or more.

Both LDRT and HDRT showed similar rates of acute toxicity and duration of pain relief, suggesting that LDRT could be a safe and effective alternative for palliative treatment of painful bone lesions in MM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Pain Control With Very Low Dose Palliative Radiation Therapy for Patients With Multiple Myeloma With Uncomplicated Osseous Lesions. Price, JG., Niedzwiecki, D., Oyekunle, T., et al.[2021]

In a study of 46 multiple myeloma patients, a single fraction of 8 Gy radiotherapy effectively reduced pain in 78.3% of cases, with 43.5% experiencing complete pain relief.

The treatment also promoted bone recalcification in 55% of patients, with manageable side effects that were mostly mild and reversible, indicating its safety and efficacy in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of one fraction of 8 Gy radiotherapy in palliative treatment of multiple myeloma patients with painful bone destructions. Rudzianskiene, M., Inciura, A., Juozaityte, E., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Palliative radiation therapy for multiple myeloma]. [2011]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Local Radiation Therapy for Palliation in Patients With Multiple Myeloma of the Spine. [2020]

3. England pubmed.ncbi.nlm.nih.gov

The role of external beam radiotherapy in the management of bone metastases. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A systematic overview of radiation therapy effects in skeletal metastases. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Radiation therapy in multiple myeloma. [2004]

6. France pubmed.ncbi.nlm.nih.gov

[Conformal radiotherapy for vertebral bone metastasis]. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Radiation therapy for the palliation of multiple myeloma. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Radiotherapy of Bone Metastasis in Breast Cancer Patients - Current Approaches. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Role of radiotherapy in the treatment of multiple myeloma]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Effective Pain Control With Very Low Dose Palliative Radiation Therapy for Patients With Multiple Myeloma With Uncomplicated Osseous Lesions. [2021]

11. Turkey pubmed.ncbi.nlm.nih.gov

The impact of one fraction of 8 Gy radiotherapy in palliative treatment of multiple myeloma patients with painful bone destructions. [2022]