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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)


Phase 1/Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma

Outcome Time Frame:

30 days from the time of aSCT

Safety Issue:

No

Principal Investigator

Harold L Atkins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ottawa Hospital Research Institute

Authority:

Canada: Ethics Review Committee

Study ID:

2008519-01H

NCT ID:

NCT00800059

Start Date:

November 2008

Completion Date:

November 2015

Related Keywords:

  • Multiple Myeloma
  • Relapse
  • Refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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