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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:  NCT00679367
Date of registration: 14/05/2008
Prospective Registration: Yes
Primary sponsor: Boston Medical Center
Public title: Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis MRD
Scientific title: A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis
Date of first enrolment: May 2008
Target sample size: 16
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00679367
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Vaishali Sanchorawala, MD
Address: 
Telephone:
Email:
Affiliation:  Boston Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of primary systemic amyloidosis

PATIENT CHARACTERISTICS:

- Not pregnant

- Negative pregnancy test

- Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day,
therapeutic warfarin, or low molecular weight heparin)

PRIOR CONCURRENT THERAPY:

- Recovered from prior therapy

- Permanent or stable side effects/changes allowed

- Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed

- More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or
radiotherapy

Exclusion Criteria:

- No secondary or familial amyloidosis

- No multiple myeloma (= 30% plasma cells in bone marrow biopsy or lytic bone lesions)

- No prior cumulative doses of oral melphalan > 200 mg

- No more than one prior course of high-dose melphalan with stem cell transplant



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Myeloma
Intervention(s)
Drug: dexamethasone
Drug: lenalidomide
Drug: melphalan
Primary Outcome(s)
Number of Participants With Hematologic Response [Time Frame: one year]
Secondary Outcome(s)
Number of Organs Improved or Stable Based on Description Below: [Time Frame: one year]
Number of Participants Removed From Study Due to Toxicities [Time Frame: One year]
Secondary ID(s)
BUMC-H-26320
CDR0000595759
RV-AMYL-PI-0219
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 20/02/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00679367
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