Multiple Myeloma

Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.1 Worldwide, more than 200,000 people are living with multiple myeloma and approximately 100,000 new cases are diagnosed annually.2 Despite treatment advances in the last several years, multiple myeloma remains a disease with poor long-term survival as a result of patients relapsing and/or becoming resistant to treatment, underlining the need for new therapies.

Onyx is conducting multiple trials evaluating carfilzomib as a monotherapy in relapsed and/or refractory multiple myeloma patients and in combination with other anticancer agents and chemotherapies.

For a more comprehensive list of carfilzomib clinical trials, please visit www.clinicaltrials.gov.

Phase 3 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma - FOCUS
Currently enrolling
Study Design: Randomized, open-label, multicenter
Patients: Patients with relapsed and refractory multiple myeloma who received at least three prior treatments including currently available classes of anti-myeloma agents, were refractory to most recent therapy, but who were responsive to at least one therapy, and who received prior treatment with all available anti-myeloma agents
Purpose: To compare effectiveness of carfilzomib when compared to best supportive care (low dose corticosteroid +/ low dose alkylating agents) by assessing the difference in progression-free survival (PFS)
Locations: Multiple sites throughout Europe

Phase 3 Study of Carfilzomib with Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma - ASPIRE
Currently enrolling
Study Design: Randomized, open-label, multicenter
Patients: Patients with relapsed multiple myeloma who received one to three prior treatments
Purpose: To determine the effectiveness of carfilzomib plus lenalidomide and low-dose dexamethasone when compared to lenalidomide and low-dose dexamethasone alone by assessing the difference in progression-free survival (PFS), as well as to measure overall response rate, safety and efficacy
Location: Multiple centers throughout the U.S., Canada, Europe and Israel

Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma – 004 *
Enrollment Completed
Study Design: Non-randomized, open-label, single-arm
Patients: Patients with relapsed/refractory multiple myeloma who have previously received one to three prior therapies and were relapsed and/or refractory to the most recently received therapy
Purpose: To evaluate the best overall response rate, safety and tolerability of carfilzomib
Location: Multiple centers throughout the U.S. and Canada

Phase 1b/2 Study of Carfilzomib in Combination with Lenalidomide and Low Dose Dexamethasone in Relapsed Multiple Myeloma - 006
Enrollment Completed
Study Design: Non-randomized, open-label, single-arm
Patients: Newly diagnosed, previously untreated multiple myeloma patients requiring systemic chemotherapy
Purpose: Phase 1 portion of the trial is to evaluate safety and maximum tolerated dose of carfilzomib and lenalidomide in combination with low dose dexamethasone in newly diagnosed patients with multiple myeloma who have not received prior treatment
Location: Multiple centers throughout the U.S.

*Sponsored by Onyx Pharmaceuticals, Celgene Corporation and the Multiple Myeloma Research Consortium

1. National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
2. International Agency for Research on Cancer, GLOBOCAN 2002 database

Stock Quote (update every 15 minutes): As of 4:00pm - 5/20/2011

  • Symbol
    ONXX
  • Last
    43.71 +0.22
  • Open
    43.46
  • High
    43.81
  • Low
    42.49
  • Volume
    1139204