S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patien… (NCT00064337) | Clinical Trial Compass
CompletedPhase 2
S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
United States104 participantsStarted 2004-01
Plain-language summary
RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving melphalan together with autologous stem cell transplantation works in treating patients with multiple myeloma or primary systemic amyloidosis.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* At least 1 of the following diagnoses:
* Multiple myeloma
* Stage II or III disease
* At least 1 of the following must be present:
* Serum M-protein of IgG, IgA, IgD, IgE greater than 1.0 g/dL
* Urinary M-protein (Bence-Jones) at least 200 mg/24 hours
* No IgM peaks except in patients who have physiologic criteria to support a diagnosis of multiple myeloma (e.g., bony lesions, myeloma kidney-cast nephropathy, absence of adenopathy \[unless pathology-proven to be plasma cell infiltration\])
* No monoclonal gammopathy of undetermined significance
* No indolent or smoldering myeloma
* No disease progression on prior thalidomide or dexamethasone
* Histologically confirmed primary systemic amyloidosis
* No senile, secondary, localized, dialysis-related, or familial amyloidosis
* No severe cardiac involvement
* No pre-exertional syncope, ventricular arrhythmia, or symptomatic pleural effusions associated with cardiac involvement
* Light Chain Deposition Disease alone or in combination with multiple myeloma meeting the following criteria:
* Deposition of granular material containing free light chains/immunoglobulins that did not bind Congo red
* Evidence of plasma cell dyscrasia (i.e., monoclonal gammopathy in the serum or urine by immunofixation electrophoresis and/or clonal plasmacytosis) on bone marrow biopsy by immunohistochemistry and/or elevated serum-free light chain concentratio…
What they're measuring
1
Overall Survival
Timeframe: 5 years from initial registration, or until death, whichever occurred earlier, on average, about 4.5 years