Status:
COMPLETED
Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs such as melphalan, thalidomide, and dexamethasone may be effective in treating patients with primary systemic amyloidosis. PURPOSE: This phase II trial is studying how well giving me...
Detailed Description
OBJECTIVES: Primary * Determine the 2-year and overall progression-free survival of patients with newly diagnosed, previously untreated primary systemic (AL) amyloidosis treated with risk-adapted me...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of primary systemic (AL) amyloidosis within the past 12 months
- High- or low-risk disease, determined by the extent of systemic organ involvement with disease and patient age
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- SWOG 0-3
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Cardiovascular
- No New York Heart Association class III or IV congestive heart failure
- No restrictive cardiomyopathy requiring oxygen
- No myocardial infarction within the past 6 months
- No symptomatic cardiac arrhythmia within the past 60 days
- Other
- No other active 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 cancer in complete remission
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for AL amyloidosis
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- No other prior or concurrent therapy for AL amyloidosis
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00089167
Start Date
May 1 2002
Last Update
January 16 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021