Novel agent-based continuous therapy significantly improved progression-free survival, both when measured from random assignment until first and second progression or death, and overall survival in patients with newly diagnosed multiple myeloma, a new study published in the Journal of Clinical Oncology has shown.

For the study, researchers in Italy pooled data from three phase 3 trials that randomly assigned 1,218 patients with newly diagnosed multiple myeloma to novel agent-based continuous therapy or fixed duration of therapy.

Primary endpoints were progression-free survival 1 (PFS1; time from random assignment until the first progression or death), PFS2 (time from random assignment until the second progression death), and overall survival.

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Results showed that during a median follow-up of 52 months, continuous therapy significantly improved PFS1 by a median of 16 months compared with fixed duration of therapy (32 versus 16 months; HR = 0.47; 95% CI, 0.40, 0.56; P<0.001).

Continuous therapy also significantly improved PFS2 by a median of 15 months (55 versus 40 months; HR = 0.61; 95% CI: 0.50, 0.75; P<0.001).

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The study demonstrated a 69% 4-year overall survival with continuous therapy compared with 60% with fixed duration of therapy (HR = 0.69; 95% CI, 0.54, 0.88; P=0.003).

The findings suggested that the benefit reported during first remission may not be negated by a shorter second remission. The authors also noted that that PFS2 is a valuable endpoint to evaluate long-term clinical benefit and should be used in future clinical trials.


  1. Palumbo A, Gay F, Cavallo F, et al. Continuous therapy versus fixed duration of therapy in patients with newly diagnosed multiple myeloma. J Clin Oncol. 2015. [epub ahead of print]. doi: 10.1200/JCO.2014.60.2466.