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Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00800059
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ottawa Hospital Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Harold L Atkins, MD
Principal Investigator Affiliation Ottawa Hospital Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Multiple Myeloma
Arms & Interventions

Arms

Experimental: Treatment

Treatment with TMI and autologous Stem Cell transplant

Interventions

Radiation: - Total Marrow Irradiation

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Ottawa Hospital, Ottawa, Ontario, Canada

Status

Recruiting

Address

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6

Site Contact

Harold Atkins, MD

hatkins@ohri.ca

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