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

July 23, 2015 updated by: Ottawa Hospital Research Institute

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital
        • Contact:
        • Principal Investigator:
          • Rajiv Samant, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
Treatment with TMI and autologous Stem Cell transplant
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 Names:
  • TMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days from the time of aSCT

Secondary Outcome Measures

Outcome Measure
Time Frame
The frequency and timing of engraftment following TMI and aHSCT
Time Frame: within 30 days of aHSCT
within 30 days of aHSCT
The early morbidity and mortality associated with TMI and aHSCT
Time Frame: 30 days from aHSCT
30 days from aHSCT
The intermediate morbidity and mortality associated with TMI and aHSCT
Time Frame: 100 days from aHSCT
100 days from aHSCT
The late morbidity of TMI
Time Frame: Beyond 6 months after transplantaton
Beyond 6 months after transplantaton

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

November 1, 2020

Study Completion (ANTICIPATED)

November 1, 2025

Study Registration Dates

First Submitted

November 27, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (ESTIMATE)

December 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008519-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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