Recruiting
Phase 1
Phase 2

Total Marrow Irradiation & Autologous Stem Cell Transplantation

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT00800059

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Total Marrow Irradiation

Study Details

Brief 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.

Conditions

Multiple Myeloma

Study ID

NCT00800059

Start date

Nov, 2008

Status verified date

Jul, 2015

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

27 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Treatment with TMI and autologous Stem Cell transplant

Interventions

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.

Primary outcome measure

  • To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma [ Time Frame: 30 days from the time of aSCT ]

Central Contacts and Locations

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Harold Atkins, MD

hatkins@ohri.ca

Principal Investigator:

Rajiv Samant, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 27, 2015

Last verified

Jul, 2015

Keywords

  • Relapse
  • Refractory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2015-07-27.