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

L

Lithuanian University of Health Sciences

Status and phase

Unknown
Phase 3

Conditions

Multiple Myeloma and Malignant Plasma Cell Neoplasms

Treatments

Radiation: External Beam radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02024815
MM81310

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 .

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

External Beam radiotherapy
Experimental group
Description:
Single 8 Gy fraction
Treatment:
Radiation: External Beam radiotherapy
3 Gy x 10 fractions
Active Comparator group
Description:
External Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction.
Treatment:
Radiation: External Beam radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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