Comparable Investigation of One Fraction Radiotherapy and Multifraction Radiotherapy in Patients With Multiple Myeloma.
Primary Purpose
Multiple Myeloma and Malignant Plasma Cell Neoplasms
Status
Unknown status
Phase
Phase 3
Locations
Lithuania
Study Type
Interventional
Intervention
External Beam radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma and Malignant Plasma Cell Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Karnofsky index more than 40%
- Patients with painful bone destructions.
- Patients with impending fracture in the region of destructions
Exclusion Criteria:
- Patients with bone metastases from solid tumors
- Patients with solitary plasmacytoma
- Patients who had received previous irradiation to the present painful destruction site,
- Patients who were incapable to complete the quality of life questionnaires
- Patients with poor health status .
Sites / Locations
- Oncology Institute of Lithuanian of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
External Beam radiotherapy
3 Gy x 10 fractions
Arm Description
Single 8 Gy fraction
External Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction.
Outcomes
Primary Outcome Measures
To analyzed the pain relief in visual analogue scalewith the scale endpoints from 0 to 10 of two different radiotherapeutic regimens.
Secondary Outcome Measures
To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.
Full Information
NCT ID
NCT02024815
First Posted
December 19, 2013
Last Updated
December 28, 2013
Sponsor
Lithuanian University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02024815
Brief Title
Comparable Investigation of One Fraction Radiotherapy and Multifraction Radiotherapy in Patients With Multiple Myeloma.
Official Title
Comparable Investigation of One Fraction Radiotherapy (8 Gy x 1) and Multifraction Radiotherapy (3 Gy x 10) of Painful Bone Destructions in Patients With Multiple Myeloma.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Radiotherapy is required to overcome pain and to evoke recalcification in multiple myeloma (MM) patients. Approximately 70% of all MM patients receive one or more radiotherapies in the course of their illness. The relief of pain is obtained in 75 - 100%. Recalcification is achieved in 40 - 50% of the irradiated bone destructions.There were a lot of randomized trials showed the same effect of single (SF) and multiple fractions (MF) in pain relief and recalcification for patients with painful bone metastases from solid tumors. The role of different palliative radiotherapeutic regimens for MM is not well established due to lack of clinical trials. Our prospective study analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, analgesics consumption and recalcification.
Detailed Description
The primary aim of our prospective study is to analyzed the effect of two different radiotherapeutic regimens in the treatment of MM on pain relief, the secondary aim is to analyzed the effect of two different radiotherapeutic regimens in the analgesics consumption and recalcification.
Eligibility criteria are age more than 18 years, Karnofsky index more than 40%, patients with painful bone destructions, patients with impending fracture in the region of destructions.
Exclusion Criteria are: patients with bone metastases from solid tumors, patients with solitary plasmacytoma, patients who had received previous irradiation to the present painful destruction site, patients who were incapable to complete the quality of life questionnaires, patients with poor health status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Malignant Plasma Cell Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
External Beam radiotherapy
Arm Type
Experimental
Arm Description
Single 8 Gy fraction
Arm Title
3 Gy x 10 fractions
Arm Type
Active Comparator
Arm Description
External Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction.
Intervention Type
Radiation
Intervention Name(s)
External Beam radiotherapy
Intervention Description
External Beam radiotherapy
Primary Outcome Measure Information:
Title
To analyzed the pain relief in visual analogue scalewith the scale endpoints from 0 to 10 of two different radiotherapeutic regimens.
Time Frame
At admission and after 4, 12 and 24 weeks after radiotherapy
Secondary Outcome Measure Information:
Title
To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.
Time Frame
At admission and after 4, 12 and 24 weeks after radiotherapy
Other Pre-specified Outcome Measures:
Title
To analyzed the recalcification on X rays in two different radiotherapeutic regimens arms.
Time Frame
At admission and after 4, 12 and 24 weeks after radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Karnofsky index more than 40%
Patients with painful bone destructions.
Patients with impending fracture in the region of destructions
Exclusion Criteria:
Patients with bone metastases from solid tumors
Patients with solitary plasmacytoma
Patients who had received previous irradiation to the present painful destruction site,
Patients who were incapable to complete the quality of life questionnaires
Patients with poor health status .
Facility Information:
Facility Name
Oncology Institute of Lithuanian of Health Sciences
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
12. IPD Sharing Statement
Learn more about this trial
Comparable Investigation of One Fraction Radiotherapy and Multifraction Radiotherapy in Patients With Multiple Myeloma.
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