Back to resultsTotal Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma (TMI-ASCT)
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Total Marrow Irradiation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapse, Refractory
Eligibility 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.
Sites / Locations
- The Ottawa HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Treatment with TMI and autologous Stem Cell transplant
Outcomes
Primary Outcome Measures
To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma
Secondary Outcome Measures
The frequency and timing of engraftment following TMI and aHSCT
The early morbidity and mortality associated with TMI and aHSCT
The intermediate morbidity and mortality associated with TMI and aHSCT
The late morbidity of TMI
Full Information
NCT ID
NCT00800059
First Posted
November 27, 2008
Last Updated
July 23, 2015
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00800059
Brief Title
Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma
Acronym
TMI-ASCT
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Recruiting
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapse, Refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with TMI and autologous Stem Cell transplant
Intervention Type
Radiation
Intervention Name(s)
Total Marrow Irradiation
Other Intervention Name(s)
TMI
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The frequency and timing of engraftment following TMI and aHSCT
Time Frame
within 30 days of aHSCT
Title
The early morbidity and mortality associated with TMI and aHSCT
Time Frame
30 days from aHSCT
Title
The intermediate morbidity and mortality associated with TMI and aHSCT
Time Frame
100 days from aHSCT
Title
The late morbidity of TMI
Time Frame
Beyond 6 months after transplantaton
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold L Atkins, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harold Atkins, MD
Email
hatkins@ohri.ca
First Name & Middle Initial & Last Name & Degree
Rajiv Samant, MD
12. IPD Sharing Statement
Learn more about this trial
Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma
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