Clinical trial NCT00800059: Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Relapse
Refractory
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2008-12-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma
timeFrame: 30 days from the time of aSCT
Secondary outcomes:
measure: The frequency and timing of engraftment following TMI and aHSCT
timeFrame: within 30 days of aHSCT
measure: The early morbidity and mortality associated with TMI and aHSCT
timeFrame: 30 days from aHSCT
measure: The intermediate morbidity and mortality associated with TMI and aHSCT
timeFrame: 100 days from aHSCT
measure: The late morbidity of TMI
timeFrame: Beyond 6 months after transplantaton
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Harold L Atkins, MD
role: PRINCIPAL_INVESTIGATOR
References: