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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00075608
Date of registration: 09/01/2004
Prospective Registration: No
Primary sponsor: Boston Medical Center
Public title: 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Scientific title: Phase II Trial of Second Autologous Transplantation in AL Amyloidosis
Date of first enrolment: August 2001
Target sample size: 12
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00075608
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Karen Quillen, MD
Address: 
Telephone:
Email:
Affiliation:  Boston Medical Center
Key inclusion & exclusion criteria

Inclusion criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed AL amyloidosis

- Persistent or recurrent disease after 1 course of prior high-dose chemotherapy

- Previously treated with autologous stem cell transplantation

- Significant initial improvement in organ function after prior high-dose melphalan,
defined by at least 1 of the following:

- Complete hematologic remission (e.g., absence of monoclonal spike by
immunofixation in serum and urine AND less then 5% plasma cells in bone marrow
with no clonal predominance) OR partial hematologic response (e.g., any decrease
in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis)

- Greater than 50% reduction in proteinuria with preservation of creatinine
clearance

- Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in
liver size by physical exam

- Subjective neurologic improvement, as confirmed by neurologist

- Cardiac stabilization of disease confirmed by echocardiography defined as less
than 2 mm increase in mean wall thickness and/or less than 20 g increase in left
ventricular mass

- Improvement in performance status* NOTE: *This criteria alone does not constitute
significant improvement in organ function

- Prior stem cell yield must have been = 2 x 10^6 CD34+ cells/kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

- No chemotherapy after first transplantation

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 to 65

Performance status

- Southwest Oncology Group- 0-2

Life expectancy

- More than 6 months

Hematopoietic

- See Disease Characteristics

Hepatic

- See Disease Characteristics

Renal

- See Disease Characteristics

Cardiovascular

- See Disease Characteristics

- Left ventricular ejection fraction = 45% by multiple gated acquisition scan or
echocardiogram

Pulmonary

- diffusing capacity of lung for carbon monoxide = 50%

Exclusion Criteria:

- No myelodysplastic syndromes

- No abnormal bone marrow cytogenetics

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Acceptable toxicity from first transplantation, confirmed by the transplant team

- HIV negative

- No other concurrent malignancy except treated skin cancer



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Myeloma
Plasma Cell Neoplasm
Intervention(s)
Biological: filgrastim
Drug: melphalan
Procedure: autologous stem cell transplantation
Procedure: stem cell infusion
Primary Outcome(s)
Evaluate Immune Reconstitution [Time Frame: 3 months after treatment and annually]
Feasibility and Tolerability [Time Frame: 3 months after treatment and annually]
Response and Durability of Response [Time Frame: 3 months after treatment and annually]
Secondary Outcome(s)
Secondary ID(s)
CDR0000347379
H-22603
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 27/01/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00075608
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