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The Lancet Oncology has published findings from a study, which showed that the new oral therapy IMNOVID® - (pomalidomide), used in combination with low-dose dexamethasone demonstrated a significant survival advantage over high-dose dexamethasone alone, in patients with relapsed and refractory multiple myeloma (rrMM).
"Unfortunately the prognosis for relapsed and refractory multiple myeloma is poor as there are few effective therapeutic options for people living with this disease" said Professor Steve Schey, Kings College London, author and UK Principal Investigator of the study. "While remission is generally achieved after initial treatment, in the majority of cases the cancer returns and these patients relapse, requiring further treatment. The results of this study have shown that there is a new and effective treatment available for patients who have failed all existing options."
The study, known as MM-003, is a Phase III, multi-centre, randomised, open-label study, which involved 455 patients from 16 countries, including the UK, between March 2011 and September 2012. The study was designed to compare the efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in patients with rrMM. The results demonstrated significantly improved median progression-free survival, the primary end point, of 4 months for patients who were treated with pomalidomide plus low-dose dexamethasone compared with 1.9 months for those treated with high-dose dexamethasone only (p<0.001). In addition a significant overall survival of 12.7 months in patients with rrMM was observed compared with 8.1 months for those treated with high-dose dexamethasone alone (p=0.028). The most common Grade 3 to 4 adverse events were neutropenia, anaemia and thrombocytopenia.
Multiple myeloma is the second most common blood cancer and affects an estimated 9,900 people in the UK and Ireland. The disease causes plasma cells to replicate uncontrollably and accumulate in the bone marrow, disrupting the production of normal blood cells. Nearly all individuals diagnosed with multiple myeloma will eventually relapse and require treatment with an alternative therapy. For this reason, it is crucial that new and effective options continue to be made available to them to enable continued disease control.
Pomalidomide was granted Marketing Authorisation by the European Medicines Agency in August 2013 and is now available in the UK and Ireland.
Pomalidomide is an oral immunomodulatory drug (IMiD®) with a multi-modal mechanism of action consisting of three main effects demonstrated in vitro: direct antimyeloma, stromal inhibitory effects and immunomodulatory effects. Pomalidomide in combination with dexamethasone has been approved for adult patients who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.
The recommended starting dose of pomalidomide is 4 mg once daily, orally on days 1-21 of repeated 28-day cycles until disease progression. Pomalidomide should be given with low-dose dexamethasone.
1. San Miguel J. et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone for patients with relapsed and refractory multiple myeloma (MM-003): a randomized, open-label, phase 3 trial. Lancet Oncology manuscript. 2013
2. Myeloma UK. Who gets myeloma and what casues it. Available from: http://www.myeloma.org.uk/intro-to-myeloma/what-is-myeloma/what-causes-it/ [last accessed: August 2013]
3. European Cancer Observatory. EUCAN Factsheet. Multiple myeloma and immunoproliferative diseases. Available from: http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=39 [Last accessed: September 2013]
4. Myeloma UK. Relapsing myeloma. Available from: http://www.myeloma.org.uk/intro-to-myeloma/relapsing-myeloma/ [Last accessed: September 2013]
5. Song KW, et al. Quality of life improvements for pomalidomide plus low-dose dexamethasone in relapsed and refractory multiple myeloma patients enrolled in MM-003. Clin Oncol 31, 2013 (suppl; abstract 8583)
6. Multiple Myeloma Research Foundation. Relapsed refractory patients: Treatment options – Pomalyst. Available from: http://www.themmrf.org/living-with-multiple-myeloma/relapsed-refractory-patients/treatment-options/pomalidomide.html. [Last accessed September 2013].
The Lancet Oncology, Early Online Publication, 3 September 2013 doi:10.1016/S1470-2045(13)70380-2
Prof Jesus San Miguel MD, Katja Weisel MD, Philippe Moreau MD, Martha Lacy MD, Kevin Song MD, Michel Delforge MD, Lionel Karlin MD, Hartmut Goldschmidt MD, Anne Banos MD, Albert Oriol MD, Adrian Alegre MD, Christine Chen MD, Michele Cavo MD, Laurent Garderet MD, Valentina Ivanova MD, Joaquin Martinez-Lopez MD, Andrew Belch MD, Antonio Palumbo MD, Stephen Schey MD, Pieter Sonneveld MD, Xin Yu PhD, Lars Sternas MD, Christian Jacques MD, Mohamed Zaki MD, Meletios Dimopoulos MD
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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