Comparable Investigation of One Fraction Radiotherapy and Multifraction Radiotherapy in Patients With Multiple Myeloma.

December 28, 2013 updated by: Arturas Inciura, Lithuanian University of Health Sciences

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Kaunas, Lithuania, 50009
        • Oncology Institute of Lithuanian of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: External Beam radiotherapy
Single 8 Gy fraction
Radiation: External Beam radiotherapy
External Beam radiotherapy
ACTIVE_COMPARATOR: 3 Gy x 10 fractions
External Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction.
Radiation: External Beam radiotherapy
External Beam radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At admission and after 4, 12 and 24 weeks after radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.
Time Frame: At admission and after 4, 12 and 24 weeks after radiotherapy
At admission and after 4, 12 and 24 weeks after radiotherapy

Other Outcome Measures

Outcome Measure
Time Frame
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
At admission and after 4, 12 and 24 weeks after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 28, 2013

First Posted (ESTIMATE)

December 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 28, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM81310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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