Using Total Marrow Irradiation and Stem Cell Transplant for Myeloma
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)
This study is testing if a new way of using radiation and stem cell transplants can help people with relapsed or hard-to-treat multiple myeloma feel better while being safer than older methods.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT00800059 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Total Marrow Irradiation (TMI) followed by autologous stem cell transplantation (aHSCT) in patients with relapsed or refractory multiple myeloma. The primary goal is to determine the maximum tolerated dose of TMI while minimizing toxicity to normal tissues compared to traditional total body irradiation. By escalating the dose of TMI, the study aims to improve disease response and control in affected patients. Participants will be closely monitored to assess the effectiveness and safety of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with relapsed or refractory multiple myeloma who meet specific health criteria for stem cell transplantation.
Not a fit: Patients with non-secretory multiple myeloma or those outside the age range or with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to better disease control and improved outcomes for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific method of TMI combined with aHSCT is still being evaluated for its effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Harold L Atkins, MD — Ottawa Hospital Research Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.