ISRCTN13400668
Completed
Phase 1
A Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis
niversity Hospital Southampton NHS Foundation Trust0 sites10 target enrollmentNovember 15, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Systemic AL-Amyloidosis
- Sponsor
- niversity Hospital Southampton NHS Foundation Trust
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged \=18 years
- •2\. Diagnosis of systemic AL\-amyloidosis, either as a new diagnosis or recurrent disease
- •3\. Measurable clonal plasma cell dyscrasia
- •4\. Amyloid related organ dysfunction or organ syndrome
- •5\. Estimated life expectancy of at least 6 months (as defined at trial entry)
- •6\. Sufficient stem cells for two transplant procedures
- •7\. Bone Marrow (BM) cellularity \>20%
- •8\. Eligible for ASCT in AL amyloidosis defined as fulfilling all of the following criteria:
- •8\.1\. ECOG Performance Status of 0 or 1
- •8\.2\. Cardiac troponin\-T \<0\.07 µg/L
Exclusion Criteria
- •1\. Overt symptomatic multiple myeloma
- •2\. Amyloidosis of unknown or non AL type
- •3\. Localised AL\-amyloidosis (in which amyloid deposits are limited to a typical single organ, for example the bladder or larynx, in association with a clonal proliferative disorder within that organ)
- •4\. Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome)
- •5\. NYHA Class III or IV heart failure
- •6\. Liver involvement by amyloid causing bilirubin \>1\.5 times upper limit of normal
- •7\. Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas
- •8\. Pregnant, lactating or unwilling to use adequate contraception
- •9\. Intolerance / sensitivity to any of the study drugs
- •10\. Known positive Human anti\-murine antibodies (HAMA)
Outcomes
Primary Outcomes
Not specified
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