2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis

• 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
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Karen Quillen, MD
• 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)

Drug: melphalan

Biological: filgrastim

Procedure: stem cell infusion

Procedure: autologous stem cell transplantation

Primary Outcome(s)

Response and Durability of Response [Time Frame: 3 months after treatment and annually]

Feasibility and Tolerability [Time Frame: 3 months after treatment and annually]

Evaluate Immune Reconstitution [Time Frame: 3 months after treatment and annually]

Secondary ID(s)

H-22603

CDR0000347379

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00075608