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Radiation

Total Marrow Irradiation for Multiple Myeloma (TMI-ASCT Trial)

Phase 1 & 2
Recruiting
Led By Harold L Atkins, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must meet institutional guidelines for autologous HSCT with adequate renal, cardiac, pulmonary and hepatic function.
Subject must have primary refractory or relapsed multiple myeloma.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to give radiation to patients with cancer in the bone marrow, to see if it is more effective than the current method with less side effects.

Who is the study for?
This trial is for adults aged 18-60 with relapsed or refractory multiple myeloma, who have measurable monoclonal gammopathy. They must have enough cryopreserved stem cells for transplantation and be in good enough health to undergo the procedure. Pregnant women, those with non-secretory myeloma or other plasma cell disorders, previous radiation treatments, severe concurrent illnesses, or a history of non-compliance are excluded.
What is being tested?
The study tests if Total Marrow Irradiation (TMI) can deliver higher doses to bone marrow malignancies compared to traditional methods without increasing toxicity. It's a dose escalation study aiming to find the maximum tolerated dose of TMI before autologous hematopoietic stem cell transplantation in patients with multiple myeloma.
What are the potential side effects?
Potential side effects may include increased risk of infection due to immune system suppression, damage to organs near treated areas from radiation exposure, fatigue from high-dose irradiation and possible complications related to stem cell transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart, kidneys, liver, and lungs are healthy enough for a stem cell transplant.
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My multiple myeloma has not responded to initial treatment or has come back.
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I am between 19 and 59 years old.
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I am able to care for myself and perform daily activities.
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I have a stem cell graft with enough cells for transplantation stored.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a plasma cell disorder that is not multiple myeloma.
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I haven't had intense corticosteroid treatment for my multiple myeloma.
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I have had radiation or been treated for cancer before.
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My doctor expects I have more than 6 months to live despite my illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 1 trial • 12 Patients • NCT02043847
33%
Mucositis
33%
Diarrhea
33%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1Total Marrow Irradiation (TMI) 3Gy
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
Cohort 3 Total Marrow Irradiation (TMI) 9Gy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with TMI and autologous Stem Cell transplant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Marrow Irradiation
2014
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,873 Total Patients Enrolled
Harold L Atkins, MDPrincipal InvestigatorOttawa Hospital Research Institute
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Total Marrow Irradiation (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT00800059 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Treatment
Multiple Myeloma Clinical Trial 2023: Total Marrow Irradiation Highlights & Side Effects. Trial Name: NCT00800059 — Phase 1 & 2
Total Marrow Irradiation (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00800059 — Phase 1 & 2
~2 spots leftby Nov 2025
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