Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease (high-risk multiple myeloma vs primary systemic amyloidosis vs both).
Induction therapy (multiple myeloma patients only): Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral thalidomide daily on days 1-35. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Mobilization and stem cell collection:
All patients undergo leukapheresis for the collection of stem cells until the target number of CD34+ cells is reached.
Patients undergo a second autologous PBSC transplantation within 3-6 months, but no later than 12 months, after the first transplantation.
Patients are followed at 3 and 6 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 20-25 months.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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:
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
Light Chain Deposition Disease alone or in combination with multiple myeloma meeting the following criteria:
Must have been diagnosed within the past year
Concurrent enrollment in the myeloma repository protocol SWOG-S0309 must be offered
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No other concurrent significant medical condition
No concurrent uncontrolled life-threatening infection
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Primary purpose
Allocation
Interventional model
Masking
104 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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