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

NCT00800059 | Unknown Phase 1 DMC

• 1 other identifier: 2008519-01H
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

Relapse; Refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The frequency and timing of engraftment following TMI and aHSCT

  within 30 days of aHSCT

• The early morbidity and mortality associated with TMI and aHSCT

  30 days from aHSCT

• The intermediate morbidity and mortality associated with TMI and aHSCT

  100 days from aHSCT

• The late morbidity of TMI

  Beyond 6 months after transplantaton

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with TMI and autologous Stem Cell transplant

Radiation: Total Marrow Irradiation

Interventions

Total Marrow Irradiation RADIATION

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.

Also known as: TMI

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harold L Atkins, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2025
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

CA (1)