Status:
TERMINATED
2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Lead Sponsor:
Boston Medical Center
Conditions:
Multiple Myeloma
Plasma Cell Neoplasm
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a stem cell transplant to replace...
Detailed Description
OBJECTIVES: * Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis. * Determine the response rate and dura...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00075608
Start Date
August 1 2001
End Date
October 1 2011
Last Update
January 27 2017
Active Locations (1)
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1
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118