| Activity of pomalidomide in patients with immunoglobulin light-chain amyloidosis. | |
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MedLine Citation:
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PMID: 22493299 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Immunoglobulin light-chain (AL) amyloidosis is a rare, incurable plasma cell disorder. Its therapy has benefited immensely from the expanding drug armamentarium available for multiple myeloma. Pomalidomide in combination with weekly dexamethasone (Pom/dex) is active among patients with relapsed myeloma. In the present study, we explored the Pom/dex combination in patients with previously treated AL. Patients were eligible for this prospective phase 2 trial if they had had at least one prior regimen and if they had reasonably preserved organ function. Patients were treated with oral Pom/dex. Thirty-three patients were enrolled. The median age was 66 years. Median time from diagnosis to on-study was 37 months. Eighty-two percent had cardiac involvement. The confirmed hematologic response rate was 48%, with a median time to response of 1.9 months. Organ improvement was documented in 5 patients. The median overall and progression-free survival rates were 28 and 14 months, respectively; the 1-year overall and progression-free survival rates were 76% and 59%, respectively. There was a discordance between the hematologic response and the N-terminal pro-brain natriuretic peptide response. The most common grade 3-5 adverse events, regardless of attribution, were neutropenia and fatigue. We conclude that pomalidomide appears to be a valuable drug covering an unmet clinical need in patients with previously treated AL. The trial is registered at www.clinicaltrials.gov as NCT00558896. |
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Authors:
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Angela Dispenzieri; Francis Buadi; Kristina Laumann; Betsy LaPlant; Suzanne R Hayman; Shaji K Kumar; David Dingli; Steven R Zeldenrust; Joseph R Mikhael; Robert Hall; S Vincent Rajkumar; Craig Reeder; Rafael Fonseca; P Lief Bergsagel; A Keith Stewart; Vivek Roy; Thomas E Witzig; John A Lust; Stephen J Russell; Morie A Gertz; Martha Q Lacy |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2012-04-04 |
Journal Detail:
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Title: Blood Volume: 119 ISSN: 1528-0020 ISO Abbreviation: Blood Publication Date: 2012 Jun |
Date Detail:
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Created Date: 2012-06-08 Completed Date: 2012-08-15 Revised Date: 2013-04-16 |
Medline Journal Info:
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Nlm Unique ID: 7603509 Medline TA: Blood Country: United States |
Other Details:
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Languages: eng Pagination: 5397-404 Citation Subset: AIM; IM |
Affiliation:
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Division of Hematology, Department of Medicine, Mayo Clinic Rochester, Rochester, NY, USA. dispenzieri.angela@mayo.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00558896 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Amyloidosis / drug therapy*, metabolism, pathology Antineoplastic Agents / adverse effects, therapeutic use* Dexamethasone / adverse effects, therapeutic use* Disease-Free Survival Drug Therapy, Combination / adverse effects Female Hematologic Tests Humans Immunoglobulin Light Chains / metabolism* Male Middle Aged Plasma Cells / drug effects*, metabolism, pathology Thalidomide / adverse effects, analogs & derivatives*, therapeutic use |
| Grant Support | |
ID/Acronym/Agency:
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P30 CA 15083/CA/NCI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Immunoglobulin Light Chains; 0/pomalidomide; 50-02-2/Dexamethasone; 50-35-1/Thalidomide |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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