Status:
UNKNOWN
Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00800059
Start Date
November 1 2008
End Date
November 1 2025
Last Update
July 27 2015
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6