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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Multiple Myeloma and Malignant Plasma Cell Neoplasms

Intervention / Treatment
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* Radiation: External Beam radiotherapy


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: External Beam radiotherapy<br>Single 8 Gy fraction | Radiation: External Beam radiotherapy<br>* External Beam radiotherapy<br>|
| Active Comparator: 3 Gy x 10 fractions<br>External Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction. | Radiation: External Beam radiotherapy<br>* External Beam radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyzed the pain relief in visual analogue scalewith the scale endpoints from 0 to 10 of two different radiotherapeutic regimens. |  | At admission and after 4, 12 and 24 weeks after radiotherapy | 

Secondary Outcome Measures

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