Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2022-03-28

Brief Summary

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This project aims to propose a new approach in the treatment of solitary plasmacytoma: hypofractionated irradiation alone with stereotactic technique that may contribute to the successful treatment of this disease.

This work aims to apply this new technique with the primary objective of reducing the progression-free survival for multiple myeloma of patients treated for solitary plasmacytoma, as well as quantify overall survival, local control, toxicities and quality of life in a phase I trial / II.

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Detailed Description

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Solitary plasmacytoma is a rare disease whose treatment has not evolved much in the last decades. The role of radiotherapy in the curative treatment of this entity was defined in a major publication in the 1980s and has since been proven to be the best practice in several other comparative trials, mostly retrospective. The radiotherapy dose of curative intent has also been described over the same period and remains unchanged to this day. Thus, local control, disease cure rate, and rate and progression time for multiple myeloma have been unaffected for almost 30 years.

Radiobiology of plasmacytoma cells is also not widely studied. The alpha / beta ratio, which defines the pattern of response of this disease to radiotherapy fractions and its response time, is also not well described. However, it is believed to be smaller in comparison to other hematological malignancies due to reports of cases of intrinsic radioresistance and late recurrence and reports of success with hypofractionated dose in isolated cases where stereotactic techniques were used such as base of skull and spine.

Conditions

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Plasmacytoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prospective Arm

Prospective arm with patients being treated with SBRT

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

Stereotactic Body Radiotherapy

Interventions

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SBRT

Stereotactic Body Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven plasmacytic for the index lesion;
* Age between 18 and 85 years;
* ECOG scale performance of 0 to 2

Exclusion Criteria

* Refuse to sign or inability to understand the term of free and informed commitment (TCLE);
* Technical limitations for treatment with SBRT among which is cited, but not limited to, weight greater than 115 Kg, inability to abduct limb to be treated in appendicular bone plasmocytomas, intolerable pain to remain in treatment position;
* Criteria for multiple myeloma at diagnosis: more than 10% of plasma cells in bone marrow biopsy, hypercalcemia greater than 11.5 mg/dL, serum creatinine greater than 2mg/dL, creatinine clearance less than 40mL/min , Hemoglobin less than 10g/dL.
* Previous cancer diagnosis and treatments;
* Previous bone events such as fractures and osteomyelitis in the bone in which the index lesion is found;
* Prior autoimmune diseases, even if controlled;
* Extra-medullary plasmacytoma requiring elective treatment of lymph node drainage;
* Current pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No