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 180,000 people are living with multiple myeloma and approximately 86,000 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 2b Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma
Enrollment completed
Study Design:  Non-randomized, open-label, single-arm
Patients:  Relapsed/refractory multiple myeloma patients who received prior treatment with bortezomib and either thalidomide or lenalidomide and were refractory to their last treatment
Purpose:  To evaluate the overall response rate, duration of treatment, and safety and tolerability of carfilzomib
Location:  Multiple centers throughout the U.S. and Canada

Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma
Study Design:  Non-randomized, open-label, single-arm
Patients:  Relapsed/refractory multiple myeloma patients 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 Multiple Myeloma
Currently enrolling
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.

Phase 1b Study of Carfilzomib with Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma
Study Design:  Non-randomized, open-label, dose comparison, single-arm
Patients:  Relapsed/refractory multiple myeloma patients
Purpose:  To evaluate safety and the maximum tolerated dose (MTD) of carfilzomib with lenalidomide and dexamethasone, as well as observe possible early evidence of efficacy and determine other pharmacokinetic (PK) parameter estimates
Location:  Multiple centers throughout the U.S.