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

Phase 3

• Conditions: Multiple Myeloma and Malignant Plasma Cell Neoplasms
• Interventions: Radiation: External Beam radiotherapy

• Registration Number: NCT02024815
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-09
• Status Verified: 2013-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-28
• Last Update Submitted: 2013-12-28
• Study First Posted: 2013-12-31
• Last Update Posted: 2013-12-31
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External Beam radiotherapy	External Beam radiotherapy	Single 8 Gy fraction
3 Gy x 10 fractions	External Beam radiotherapy	External Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.	At admission and after 4, 12 and 24 weeks after radiotherapy

Trial Locations

Locations (1)

Oncology Institute of Lithuanian of Health Sciences; 🇱🇹 Kaunas, Lithuania