A Dose Escalation Study of Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) for the Treatment of Relapsed or Refractory Multiple Myeloma (MM)
- 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
- A subject meeting any of the following criteria is not eligible for participation in
- Subject with non-secretory multiple myeloma or any plasma cell disorders other that
- 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
- Subjects with a history of non-compliance in other studies.
- Pregnant or lactating female subjects.