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

Multiple Myeloma Clinical Trial

— TMI-ASCT  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00800059
• Other study ID #: 2008519-01H
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 27, 2008
• Last updated: July 23, 2015
• Start date: November 2008
• Est. completion date: November 2025

Study information

• Verified date: July 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: November 2025
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The frequency and timing of engraftment following TMI and aHSCT		within 30 days of aHSCT	No
Secondary	The early morbidity and mortality associated with TMI and aHSCT		30 days from aHSCT	No
Secondary	The intermediate morbidity and mortality associated with TMI and aHSCT		100 days from aHSCT	No
Secondary	The late morbidity of TMI		Beyond 6 months after transplantaton	No