Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma

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.

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