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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
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Malignant Plasma Cell Neoplasms

Eligibility Criteria

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

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

First Posted
December 19, 2013
Last Updated
December 28, 2013
Sponsor
Lithuanian University of Health Sciences
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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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