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

Stopped early · Phase 2

Conditions studied: Multiple Myeloma, Plasma Cell Neoplasm

In brief

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 the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly. PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.

Key facts

Study ID

NCT00075608

Run by

Boston Medical Center

People needed

12

Starts

2001-08-01

Expected to finish

2011-10-01

Last updated by the study team

2017-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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

Where it is running

• Boston University Cancer Research Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.