A 2-drug combination with subcutaneous bortezomib and oral prednisone followed by maintenance therapy should be the preferred treatment for frail patients with multiple myeloma, a study published in the journal Leukemia has shown.1

For the phase 2 trial, researchers in Italy sought to evaluate 3 low-dose intensity subcutaneous bortezomib-based treatments in patients 75 years of age or older with newly diagnosed multiple myeloma.

Investigators enrolled 152 previously untreated patients, half of whom were frail, and assigned them 1:1:1 to receive subcutaneous bortezomib plus oral prednisone (VP), VP plus cyclophosphamide (VCP), or VP plus melphalan (VMP). Participants then received maintenance therapy with bortezomib.

Continue Reading

Results showed that response rates were 64% with VP, 67% with VCP, and 86% with VMP. Very good partial responses or better occurred in 26%, 28.5%, and 49% of patients, respectively.

Researchers found that median progression-free survival was 14.0 months in the VP arm, 15.2 months in the VCP arm, and 17.1 months in the VMP arm. The 2-year overall survival rate was 60%, 70%, and 76%, respectively.

The study further demonstrated that bortezomib maintenance was effective and feasible.

In terms of safety, 22%, 27%, and 33% of VP, VCP, and VMP patients, respectively, experienced at least 1 treatment-related grade 3 or higher non-hematologic adverse event. The most common grade 3 or higher adverse events included infections (8% – 20%), constitutional (10% – 14%), and cardiovascular events (4% – 12%). Grade 3 or worse peripheral neuropathy was limited to 4% to 6% of patients.

RELATED: New Recommendations Issued for the Diagnosis, Management of Myeloma-related Renal Impairment

Ultimately, there was no substantial difference between the 3 regimens; however, toxicity was higher with VMP, suggesting that a 2-drug combination followed by maintenance therapy should be preferred in this older patient population.

Reference

  1. Larocca A, Brighen S, Petrucci MT, et al. A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma [published online ahead of print March 8, 2016]. Leukemia. doi: 10.1038/leu.2016.36.

Topics:

Hematologic Cancers Multiple Myeloma