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Smouldering myeloma patients are generally not treated until symptoms develop. The current standard of care is observation.

Previous attempts at treating smouldering myeloma with older treatments such as alkylating agents either were not effective or led to concerns about long-term toxicity.

An evaluation of an open-label Phase 3 study involving 119 patients with high-risk smouldering myeloma (split into two groups, one receiving treatment and the other one just being observed), concretely shows:

  • 77% in the smouldering group who were treated remained without symptoms after 3 years (but 23% had symptoms)
  • 30% in the smouldering who were NOT treated remained without symptoms after 3 years (but 70% had symptoms)

The study concludes, early treatment with lenalidomide (Revlimid®) and dexamethasone, followed by maintenance treatment with lenalidomide, delays the time to progression to symptomatic myeloma and increases overall survival:

  • At 3 years, 94% of patients in the treatment arm were alive
  • At 3 years, 80% in the watch-and-wait group were still alive

The risk for progression to active myeloma is only about 10% annually, say the authors. However, in a subgroup of high-risk patients, the probability of progression is much higher. About 40% of smouldering myeloma patients fall into this subgroup.

However, it is too early to make any changes in clinical practice. Lead author Jesus F. San Miguel, MD, from the Department of Hematology at the University Hospital of Salamanca in Spain states that “more trials are needed and we need to better define the ultra-high-risk population before early treatment is proposed for all patients”.

The study was published in the 1 August 2013 issue of the New England Journal of Medicine.

The study was funded by Celgene.

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