The investigators hypothesize that conformal radiation will allow the administration of higher doses of external beam radiation to marrow based malignancies than total body irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by TBI. Further,the investigators hypothesize that this will result in an improvement in disease response and disease control for patients with multiple myeloma. This is a dose escalation study of TMI with the primary objective of determining the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Total Marrow Irradiation delivered by chemotherapy delivered to cohorts of patients in a dose escalation. The initial cohort will receive 14 Gy. If tolerated subsequent cohorts will receive an additional 2 Gy until the maximum tolerated dose or 28 Gy is reached.
The Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGTo determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma
Time frame: 30 days from the time of aSCT
The frequency and timing of engraftment following TMI and aHSCT
Time frame: within 30 days of aHSCT
The early morbidity and mortality associated with TMI and aHSCT
Time frame: 30 days from aHSCT
The intermediate morbidity and mortality associated with TMI and aHSCT
Time frame: 100 days from aHSCT
The late morbidity of TMI
Time frame: Beyond 6 months after transplantaton
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