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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 have primary refractory or relapsed multiple myeloma.
Subject must have an ECOG performance score of 0,1, or 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beyond 6 months after transplantaton
Awards & highlights
No Placebo-Only Group

TMI-ASCT Trial 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.Check my eligibility
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.See study design
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.

TMI-ASCT Trial Eligibility Criteria

Inclusion Criteria

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

TMI-ASCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beyond 6 months after transplantaton
This trial's timeline: 3 weeks for screening, Varies for treatment, and beyond 6 months after transplantaton for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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 early morbidity and mortality associated with TMI and aHSCT
The frequency and timing of engraftment following TMI and aHSCT
The intermediate morbidity and mortality associated with TMI and aHSCT
+1 more

Awards & Highlights

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

TMI-ASCT 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
559 Previous Clinical Trials
2,785,525 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become a candidate for this research project?

"This clinical trial is only open to 27 patients that have multiple myeloma and are between 18-60 years old."

Answered by AI

Are elders welcome in this clinical research?

"The age group that this study is looking for are people who have not yet hit their 60th birthday but are already 18 years old or older."

Answered by AI

How many volunteers are assisting with this research?

"That is accurate. The clinical trial, which was first posted on 11/1/2008, has a current listing seeking 27 patients from 1 site."

Answered by AI

Are researchers still looking for people to participate in this trial?

"That is correct. According to the latest update on clinicaltrials.gov, this research project is still looking for volunteers. The initial posting was on November 1st, 2008 with the most recent update being from July 23rd, 2015. So far, 27 individuals have been accepted at a single location."

Answered by AI
~2 spots leftby Feb 2025