Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma

  • End date
    Nov 21, 2025
  • participants needed
  • sponsor
    Ottawa Hospital Research Institute
Updated on 21 January 2021
cell transplantation
refractory multiple myeloma


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.

Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Total Marrow Irradiation
Clinical Study IdentifierNCT00800059
SponsorOttawa Hospital Research Institute
Last Modified on21 January 2021


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Inclusion Criteria

A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within the four weeks prior to enrolment
Subject must have primary refractory or relapsed multiple myeloma
Subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse
Subject must meet institutional guidelines for autologous HSCT with adequate renal, cardiac, pulmonary and hepatic function
An autologous hematopoietic stem cell graft containing more than 2.5 x 106 CD34+ cells/kg must be cryopreserved and available for transplantation
Subject must be of age more than 18 and less than 60 years
Subject must have an ECOG performance score of 0,1, or 2
Subject must have the ability to comply with the protocol visit schedule and other protocol requirements

Exclusion Criteria

A subject meeting any of the following criteria is not eligible for participation in the study
Subject with non-secretory multiple myeloma or any plasma cell disorders other that MM
Subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma
Subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months
Subjects who have previously received radiation treatments or other neoplastic disorders
Subjects with a history of non-compliance in other studies
Pregnant or lactating female subjects
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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