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

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.

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02024815
Enrollment
100
Registered
2013-12-31
Start date
2011-09-30
Completion date
2015-06-30
Last updated
2013-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma and Malignant Plasma Cell Neoplasms

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.

Interventions

RADIATIONExternal Beam radiotherapy

External Beam radiotherapy

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime 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

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

Other

MeasureTime frame
To analyzed the recalcification on X rays in two different radiotherapeutic regimens arms.At admission and after 4, 12 and 24 weeks after radiotherapy

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026