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Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma (TMI-ASCT)

This study is currently recruiting participants.
Verified March 2010 by Ottawa Hospital Research Institute
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00800059
First received: November 27, 2008
Last updated: March 1, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Multiple Myeloma
 Radiation: Total Marrow Irradiation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • To 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The frequency and timing of engraftment following TMI and aHSCT [ Time Frame: within 30 days of aHSCT ] [ Designated as safety issue: No ]
  • The early morbidity and mortality associated with TMI and aHSCT [ Time Frame: 30 days from aHSCT ] [ Designated as safety issue: No ]
  • The intermediate morbidity and mortality associated with TMI and aHSCT [ Time Frame: 100 days from aHSCT ] [ Designated as safety issue: No ]
  • The late morbidity of TMI [ Time Frame: Beyond 6 months after transplantaton ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: November 2008
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Total Marrow Irradiation
    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.
    Other Name: TMI
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800059

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Harold Atkins, MD         hatkins@ohri.ca    
Principal Investigator: Rajiv Samant, MD            
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Harold L Atkins, MD Ottawa Hospital Research Institute
  More Information

No publications provided

Responsible Party: Dr. Harold Atkins/Physician/Principle Investigator, The Ottawa Health Research Institute
ClinicalTrials.gov Identifier: NCT00800059     History of Changes
Other Study ID Numbers: 2008519-01H
Study First Received: November 27, 2008
Last Updated: March 1, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Relapse
Refractory

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013