Clinical trial NCT03858205: Low-Dose Radiotherapy in Treating Painful Bone Metastases in Patients With Multiple Myeloma
Official title: Phase II Multi-Institutional Study of Low-Dose (2Gy) Palliative Radiotherapy in the Treatment of Symptomatic Bone Metastases From Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Pain
Metastatic Malignant Neoplasm in the Bone
Plasma Cell Myeloma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain response
timeFrame: Up to 6 months after completion of radiation therapy
Secondary outcomes:
measure: Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
timeFrame: Up to 6 months after completion of radiation therapy
measure: Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Up to 6 months after completion of radiation therapy
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota - Masonic Cancer Center
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Southern California
name: Adam Garsa, MD
role: PRINCIPAL_INVESTIGATOR
References: