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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 October 2017
Main ID:  NCT00477971
Date of registration: 23/05/2007
Prospective Registration: No
Primary sponsor: Mayo Clinic
Public title: Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
Scientific title: Phase III Trial of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis (AL)
Date of first enrolment: October 2005
Target sample size: 89
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00477971
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Morie A. Gertz, MD
Address: 
Telephone:
Email:
Affiliation:  Mayo Clinic
Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed primary systemic amyloidosis

- Amyloid light-chain (AL) disease

- Monoclonal protein by immunoelectrophoresis or immunofixation of the serum or urine OR
abnormal free light-chain ratio

- The following amyloid syndromes* are allowed:

- Amyloid hepatomegaly

- Cardiomyopathy

- Proteinuria

- Peripheral or autonomic neuropathy

- Soft tissue involvement including the tongue, submandibular tissues, and vascular
claudication

- Diffuse interstitial pulmonary AL disease allowed if pulmonary function is
adequate to allow safe transplantation NOTE: *Presence of amyloid deposits in a
plasmacytoma or in bone marrow vessels in an asymptomatic patient does not
constitute an amyloid syndrome

- No secondary or familial amyloidosis

- No multiple myeloma with lytic or destructive bone lesions or myeloma cast nephropathy

- No multiple myeloma with > 30% plasma cells in the bone marrow

- No amyloidosis manifested only by carpal tunnel syndrome or purpura

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Platelet count = 100,000/mm³

- Bilirubin = 2.0 times upper limit of normal (ULN)

- Alkaline phosphatase = 6 times ULN

- Creatinine = 3.0 mg/dL

- No NYHA class IV heart disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection

- No HIV positivity

PRIOR CONCURRENT THERAPY:

- Prior alkylating agents, immunosuppressive drugs, or steroids allowed provided they
were given for < 1 month

- Therapeutic steroid doses of = 15 mg per day (or equivalent) allowed at
discretion of physician

- No concurrent participation in another clinical trial involving a pharmacologic agent



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Myeloma and Plasma Cell Neoplasm
Intervention(s)
Biological: filgrastim
Drug: dexamethasone
Drug: melphalan
Procedure: autologous hematopoietic stem cell transplantation
Primary Outcome(s)
Hematologic Response Rate [Time Frame: 10 years]
Secondary Outcome(s)
3 Year Overall Survival [Time Frame: 3 years]
Organ Response to Treatment [Time Frame: 10 years]
Secondary ID(s)
1691-05
CDR0000546745
MC0482
NCI-2009-01329
P30CA015083
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available: Yes
Date Posted: 21/07/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00477971
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