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Trial Title:
Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma
NCT ID:
NCT00800059
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Relapse
Refractory
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Total Marrow Irradiation
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.
Arm group label:
Treatment
Other name:
TMI
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Ottawa Hospital
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Harold Atkins, MD
Email:
hatkins@ohri.ca
Investigator:
Last name:
Rajiv Samant, MD
Email:
Principal Investigator
Start date:
November 2008
Completion date:
November 2025
Lead sponsor:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Source:
Ottawa Hospital Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00800059
