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

Multiple Myeloma and Malignant Plasma Cell Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02024815
• Other study ID #: MM81310
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: December 19, 2013
• Last updated: December 28, 2013
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: December 2013
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Malignant Plasma Cell Neoplasms
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Radiation:
• External Beam radiotherapy
External Beam radiotherapy

Locations

Country	Name	City	State
Lithuania	Oncology Institute of Lithuanian of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To analyzed the recalcification on X rays in two different radiotherapeutic regimens arms.		At admission and after 4, 12 and 24 weeks after radiotherapy	No
Primary	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	No
Secondary	To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.		At admission and after 4, 12 and 24 weeks after radiotherapy	No