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

NCT02024815 | Unknown Phase 3 DMC

• 1 other identifier: MM81310
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma and Malignant Plasma Cell Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To analyzed the analgesics consumption in two different radiotherapeutic regimens arms.

  At admission and after 4, 12 and 24 weeks after radiotherapy

Other Outcomes (1)

• To analyzed the recalcification on X rays in two different radiotherapeutic regimens arms.

  At admission and after 4, 12 and 24 weeks after radiotherapy

Study Arms (2)

External Beam radiotherapy

EXPERIMENTAL

Single 8 Gy fraction

Radiation: External Beam radiotherapy

3 Gy x 10 fractions

ACTIVE COMPARATOR

External Beam radiotherapy - total dose 30 Gy, 3 Gy per fraction.

Radiation: External Beam radiotherapy

Interventions

External Beam radiotherapy RADIATION

External Beam radiotherapy

3 Gy x 10 fractions; External Beam radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnofsky index more than 40%
• Patients with painful bone destructions.
• Patients with impending fracture in the region of destructions

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Oncology Institute of Lithuanian of Health Sciences

Kaunas, 50009, Lithuania

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 31, 2013
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2015
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

LI (1)