Updated results from a 482-patient, multicenter, randomized phase III clinical trial showed significant progress in multiple myeloma treatment. The study compared bortezomib(Drug information on bortezomib) (Velcade) and dexamethasone(Drug information on dexamethasone) (VcD) to vincristine, doxorubicin(Drug information on doxorubicin) (Adriamycin), and dexamethasone (VAD) in newly diagnosed patients. Results showed high complete remission (CR) rates of 19% in the VcD arm as induction therapy and 35% posttransplantation. These high CR rates contributed to 141 patients not requiring a second transplant. In addition, data showed 95% of patients in the VcD arm were alive at 1 year.
The study was conducted by the Intergroupe Francophone du Myelome (IFM) cooperative group and Nantes University Hospital (France) and selected for an oral presentation (abstract 8505) at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, held May 30–June 3, 2008.
New Standard
“These updated results clearly confirm that the high CR rates with induction therapy improved posttransplantation outcomes, including a decrease in the need for second transplantation,” said Jean-Luc Harousseau, md, Hotel-Dieu Hospital. “We also are encouraged by the promising survival data already seen to date. This Velcade-based therapy now could be considered the standard induction treatment pretransplant to which other regimens, including novel agents, should be studied against.”
In June, after a priority review, bortezomib was approved by the US Food and Drug Administration (FDA) for use in newly diagnosed multiple myeloma. The drug had previously been approved in the United States for relapsed multiple myeloma and mantle cell lymphoma.
“These data, as well as the results from multiple clinical trials continue to demonstrate the ability of Velcade to deliver consistently high complete remission rates that lead to improved clinical benefit, including survival,” said Nancy Simonian, md, Chief Medical Officer, Millennium. “The updated results from the IFM, combined with the approval by the FDA, bring us one step further in establishing Velcade as the foundation of therapy for patients with newly diagnosed multiple myeloma.”
Results from this large clinical trial were presented by Professor Harousseau. The VcD arm vs the VAD arm showed:
• 95% of patients were alive at 1 year compared to 92%.
• A CR rate of 19% compared to 8% as induction therapy (P = .0004).
• A CR rate of 35% compared to 23% posttransplantation (P = .0063).
• 63% of patients did not require a second transplantation compared to 44% (P < .0001).
Treatment Regimens
Patients in the VcD arm received four cycles of bortezomib at 1.3 mg/m2 on days 1, 4, 8, and 11 of a 21-day cycle. Patients also received dexamethasone at 40 mg on days 1 through 4 during cycles 1 through 4 and on days 9 through 12 during cycles 1 and 2 only. The patients in the VAD arm were treated for four 28-day cycles with vincristine at 0.4 mg/m2 on days 1 through 4; doxorubicin at 9 mg/m2 on days 1 through 4; and dexamethasone at 40 mg on days 1 through 4, days 9 through 12 during cycles 1 through 4 and on days 17 through 20 during cycles 1 and 2 only. Half of the patients in each arm received dexamethasone, cyclophosphamide(Drug information on cyclophosphamide), etoposide(Drug information on etoposide), and cisplatinum (DCEP) consolidation pretransplant.
VcD was well tolerated, with the incidence of grade 3 and grade 4 adverse events similar in each arm. Serious adverse events were slightly lower with VcD.
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