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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00679367 |
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Date of registration:
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14/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
MRD |
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Scientific title:
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A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis |
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Date of first enrolment:
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May 2008 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00679367 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Vaishali Sanchorawala, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boston Medical Center |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Intervention(s)
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Drug: lenalidomide
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Drug: dexamethasone
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Drug: melphalan
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Primary Outcome(s)
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Number of Participants With Hematologic Response
[Time Frame: one year]
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Secondary Outcome(s)
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Number of Participants Removed From Study Due to Toxicities
[Time Frame: One year]
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Number of Organs Improved or Stable Based on Description Below:
[Time Frame: one year]
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Secondary ID(s)
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BUMC-H-26320
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CDR0000595759
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RV-AMYL-PI-0219
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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