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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00089167
Date of registration: 04/08/2004
Prospective Registration: No
Primary sponsor: Memorial Sloan Kettering Cancer Center.
Public title: Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
Scientific title: Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis
Date of first enrolment: May 2002
Target sample size:
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00089167
Study type:  Interventional
Study design:  Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Madhav Dhodapkar, MD
Address: 
Telephone:
Email:
Affiliation:  Memorial Sloan Kettering Cancer Center.
Name:     Raymond L. Comenzo, MD
Address: 
Telephone:
Email:
Affiliation:  Memorial Sloan Kettering Cancer Center.
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Multiple Myeloma and Plasma Cell Neoplasm
Intervention(s)
Biological: filgrastim
Drug: dexamethasone
Drug: melphalan
Drug: thalidomide
Primary Outcome(s)
Overall progression-free survival at 2 years [Time Frame: No]
Secondary Outcome(s)
Amyloid-related disease response at 12 and 24 months after treatment [Time Frame: No]
Molecular minimal residual disease at 12 and 24 months [Time Frame: No]
Plasma cell disease response at 3, 12, and 24 months after treatment [Time Frame: No]
Prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL cell clones [Time Frame: No]
Secondary ID(s)
02-031
MSKCC-02031
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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