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New Clinical Data on Bortezomib (Velcade) in Multiple Myeloma

Induction therapy more effective with bortezomib than without (Apr. 7)

Results have been announced from a meta-analysis of regimens based on bortezomib (Velcade, Millennium/Takeda) compared with non–bortezomib-based regimens as induction therapy before autologous stem cell transplant (ASCT) in patients with previously untreated multiple myeloma. The new data were reported April 7 at the 14th International Myeloma Workshop in Kyoto, Japan.

The primary objective of this meta-analysis of three phase III trials was to compare the post-transplant complete response (CR) plus near-complete response (nCR) rates and progression-free survival (PFS) of bortezomib-based induction therapy (administered intravenously, twice weekly) with non–bortezomib-based induction in 1,572 previously untreated patients with multiple myeloma undergoing ASCT. Secondary endpoints included the overall response rate (ORR) and overall survival (OS).

Key results included:

  • The post-transplant CR + nCR rate for bortezomib-based regimens was 38% (n = 298) compared with 24% (n = 182) for non–bortezomib-based regimens (P < 0.0001).
  • The median PFS was 35.9 months for bortezomib-based regimens compared with 28.6 months for non–bortezomib-based regimens (P < 0.0001).
  • The post-transplant ORR was 79% (n = 615) for bortezomib-based regimens compared with 68% (n = 526) for non–bortezomib-based regimens (P < 0.0001).
  • After a median follow-up period of 37 months, the 3-year OS rates were 79.7% for bortezomib-based treatment compared with 74.7% for non–bortezomib-based treatment (hazard ratio, 0.81; P = 0.0402). The median OS had not been reached in either treatment arm.

The most common adverse events for bortezomib-based induction regimens compared with non–bortezomib-based regimens included peripheral neuropathy (34% vs. 17%, respectively), constipation (31% vs. 28%), anemia (27% vs. 29%), nausea (28% vs. 27%), thrombocytopenia (31% vs. 22%), and leukopenia (25% vs. 27%).

Velcade (bortezomib) is approved for the treatment of patients with multiple myeloma. The drug is also approved for the treatment of patients with mantle-cell lymphoma who have already received at least one prior therapy.

Source: Millennium; April 7, 2013.

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