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

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Radiation: Total Marrow Irradiation

• Registration Number: NCT00800059
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-27
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-27
• Primary Completion: 2020-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Total Marrow Irradiation	Treatment with TMI and autologous Stem Cell transplant

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma	30 days from the time of aSCT

Secondary Outcome Measures

Name	Time	Method
The intermediate morbidity and mortality associated with TMI and aHSCT	100 days from aHSCT
The late morbidity of TMI	Beyond 6 months after transplantaton
The early morbidity and mortality associated with TMI and aHSCT	30 days from aHSCT
The frequency and timing of engraftment following TMI and aHSCT	within 30 days of aHSCT

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada