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Safety and efficacy...
Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010) : A phase 3b study in refractory multiple myeloma
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- Dimopoulos, Meletios A. (författare)
- National and Kapodistrian University of Athens
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- Palumbo, Antonio (författare)
- University of Turin
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- Corradini, Paolo (författare)
- University of Turin
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- Cavo, Michele (författare)
- University of Bologna
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- Delforge, Michel (författare)
- University Hospitals Leuven
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- Di Raimondo, Francesco (författare)
- University of Catania
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- Weisel, Katja C. (författare)
- University Hospital of Tubingen
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- Oriol, Albert (författare)
- Hospital Universitari Germans Trias i Pujol
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- Hansson, Markus (författare)
- Lund University,Lunds universitet,Avdelningen för hematologi och transfusionsmedicin,Institutionen för laboratoriemedicin,Medicinska fakulteten,Division of Hematology and Transfusion Medicine,Department of Laboratory Medicine,Faculty of Medicine,Skåne University Hospital
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- Vacca, Angelo (författare)
- University of Bari Aldo Moro
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- Blanchard, María Jesús (författare)
- Hospital Ramón Y Cajal
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- Goldschmidt, Hartmut (författare)
- University Hospital Heidelberg
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- Doyen, Chantal (författare)
- Catholic University of Louvain
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- Kaiser, Martin (författare)
- Royal Marsden Hospital, London
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- Petrini, Mario (författare)
- University of Pisa
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- Anttila, Pekka (författare)
- University of Helsinki
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- Cafro, Anna Maria (författare)
- Niguarda Hospital
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- Raymakers, Reinier (författare)
- University Medical Center Utrecht
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- San-Miguel, Jesus (författare)
- University of Navarra
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- De Arriba, Felipe (författare)
- Hospital General Universitario Morales Meseguer
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- Knop, Stefan (författare)
- University Hospital of Wϋrzburg
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- Röllig, Christoph (författare)
- Medizinsche Klinik und Poliklinik I, Dresden
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- Ocio, Enrique M. (författare)
- CSIC-USAL Instituto de Biologia Molecular y Celular del Cancer de Salamanca (IBMCC)
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- Morgan, Gareth (författare)
- University of Arkansas for Medical Sciences
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- Miller, Neil (författare)
- Celgene International Sàrl
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- Simcock, Mathew (författare)
- Celgene International Sàrl
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- Peluso, Teresa (författare)
- Celgene International Sàrl
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- Herring, Jennifer (författare)
- Celgene Corporation
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- Sternas, Lars (författare)
- Celgene Corporation
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- Zaki, Mohamed H. (författare)
- Celgene Corporation
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- Moreau, Philippe (författare)
- Nantes University Hospital
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(creator_code:org_t)
- American Society of Hematology, 2016
- 2016
- Engelska 7 s.
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Ingår i: Blood. - : American Society of Hematology. - 0006-4971 .- 1528-0020. ; 128:4, s. 497-503
- Relaterad länk:
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http://dx.doi.org/10...
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https://ashpublicati...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUS study assessed safety and efficacy of pomalidomide plus low-dose dexamethasone in the largest cohort to date of patients with RRMM. Patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy were eligible. Pomalidomide 4 mg was given on days 1-21 of 28-day cycles with low-dose dexamethasone 40 mg (20 mg for patients aged >75 years) on days 1, 8, 15, and 22 until progressive disease or unacceptable toxicity. Safety was the primary end point; secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Among 682 patients enrolled, median age was 66 years, and median time since diagnosis was 5.3 years. Median number of prior regimens was 5. Most patients were refractory to both lenalidomide and bortezomib (80.2%). Median follow-up was 16.8 months; median duration of treatment was 4.9 months. Most frequent grade 3/4 treatment-emergent adverse events were hematologic (neutropenia [49.7%], anemia [33.0%], and thrombocytopenia [24.1%]). Most common grade 3/4 nonhematologic toxicities were pneumonia (10.9%) and fatigue (5.9%). Grade 3/4 venous thromboembolism and peripheral neuropathy were rare (1.6% each). The ORR was 32.6%, and the median DOR was 7.4 months. Median PFS and OS were 4.6 months and 11.9 months, respectively. We present the largest trial to date evaluating pomalidomide plus low-dose dexamethasone in patients with RRMM, further confirming that this regimen offers clinically meaningful benefit and is generally well tolerated. www.Clinicaltrials.gov identifier NCT01712789.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
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Blood
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Dimopoulos, Mele ...
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Palumbo, Antonio
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Corradini, Paolo
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Cavo, Michele
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Delforge, Michel
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Di Raimondo, Fra ...
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Weisel, Katja C.
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Oriol, Albert
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Hansson, Markus
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Vacca, Angelo
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Blanchard, María ...
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Goldschmidt, Har ...
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Doyen, Chantal
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Kaiser, Martin
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Petrini, Mario
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Anttila, Pekka
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Cafro, Anna Mari ...
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Raymakers, Reini ...
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San-Miguel, Jesu ...
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De Arriba, Felip ...
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Knop, Stefan
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Röllig, Christop ...
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Ocio, Enrique M.
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Morgan, Gareth
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Miller, Neil
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Simcock, Mathew
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Peluso, Teresa
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Herring, Jennife ...
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Sternas, Lars
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Zaki, Mohamed H.
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Moreau, Philippe
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