Clinical trial NCT02024815: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Myeloma and Malignant Plasma Cell Neoplasms
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 .

Primary outcomes:
measure: To analyzed the pain relief in visual analogue scalewith the scale endpoints from 0 to 10 of two different radiotherapeutic regimens.
timeFrame: At admission and after 4, 12 and 24 weeks after radiotherapy
Secondary outcomes:
measure: To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.
timeFrame: At admission and after 4, 12 and 24 weeks after radiotherapy
Other outcomes:
measure: To analyzed the recalcification on X rays in two different radiotherapeutic regimens arms.
timeFrame: At admission and after 4, 12 and 24 weeks after radiotherapy
Locations:
city: Kaunas
country: Lithuania
facility: Oncology Institute of Lithuanian of Health Sciences
Study officials:
References: