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

Primary Purpose

Bone Pain, Metastatic Malignant Neoplasm in the Bone, Plasma Cell Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Radiation Therapy
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of HopeRecruiting
  • Los Angeles County-USC Medical CenterRecruiting
  • USC / Norris Comprehensive Cancer CenterRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Emory University Hospital/Winship Cancer InstituteRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • University of Minnesota - Masonic Cancer CenterRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • University of Pennsylvania/Abramson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (low-dose radiation therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

Pain response
Pain will be measured using the Brief Pain Inventory (BPI).

Secondary Outcome Measures

Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
Quality of life will be assessed before and after radiation therapy. EORTC QLQ-BM22 measures four multi-item scales: painful sites, functional interference, painful characteristics, and psychosocial aspects. Each item will be scaled as: 1= not at all; 2 = a little; 3 = quite a bit; 4 =very much. Answers will be converted into grading scale, with values between 0 and 100. Higher scores represent worse QOL for the subscales of painful sites, painful characteristics and psychosocial aspects, while higher scores in functional scale represents better functioning.
Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC QLQ-C30)
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures including functional scales, symptom scales, a global health status / QoL scale, and single item measures. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Full Information

First Posted
February 20, 2019
Last Updated
September 28, 2023
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03858205
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
March 11, 2024 (Anticipated)
Study Completion Date
March 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Pain, Metastatic Malignant Neoplasm in the Bone, Plasma Cell Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (low-dose radiation therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation
Intervention Description
Receive low-dose radiation therapy
Primary Outcome Measure Information:
Title
Pain response
Description
Pain will be measured using the Brief Pain Inventory (BPI).
Time Frame
Up to 6 months after completion of radiation therapy
Secondary Outcome Measure Information:
Title
Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Metastases Module (EORTC QLQ-BM22)
Description
Quality of life will be assessed before and after radiation therapy. EORTC QLQ-BM22 measures four multi-item scales: painful sites, functional interference, painful characteristics, and psychosocial aspects. Each item will be scaled as: 1= not at all; 2 = a little; 3 = quite a bit; 4 =very much. Answers will be converted into grading scale, with values between 0 and 100. Higher scores represent worse QOL for the subscales of painful sites, painful characteristics and psychosocial aspects, while higher scores in functional scale represents better functioning.
Time Frame
Up to 6 months after completion of radiation therapy
Title
Quality of life (QOL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC QLQ-C30)
Description
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures including functional scales, symptom scales, a global health status / QoL scale, and single item measures. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Time Frame
Up to 6 months after completion of radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Duran
Phone
323-865-0371
Email
Duran_C@med.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Garsa, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bianca Del Vecchio
Phone
626-218-4402
Email
bdelvecchio@coh.org
First Name & Middle Initial & Last Name & Degree
Savita V Dandapani, MD
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Fernando, RN
Phone
323-409-4388
Email
Donna.fernando@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Adam Garsa, MD
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Fernando, RN
Phone
323-409-4388
Email
Donna.fernando@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Adam Garsa, MD
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chace Henning
Phone
310-423-8218
Email
chace.henning@cshs.org
First Name & Middle Initial & Last Name & Degree
Harpavan Sandha
Phone
310-423-4849
Email
harpavan.sandha@cshs.org
First Name & Middle Initial & Last Name & Degree
Leslie Ballas, MD
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad K. Khan
Phone
404-778-3473
Email
Drkhurram2000@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohammad K. Khan
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Boyle
Phone
617-582-8918
Email
PJBoyle@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Carol Mayo
Phone
508-488-3800
Email
CMAYO@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Andrea K. Ng
Facility Name
University of Minnesota - Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Bak
Phone
612-301-0151
Email
kbak@umn.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Terezakis, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard L. Bakst
Phone
212-241-3545
Email
Richard.bakst@mtsinai.org
First Name & Middle Initial & Last Name & Degree
Richard L. Bakst
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dave Farraday
Phone
215-662-2709
Email
dfarrady@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Kelly Farraday
Phone
215-349-8594
Email
kellyfar@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Ima Paydar, MD

12. IPD Sharing Statement

Learn more about this trial

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

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