Expanded Access Program

 

The Carfilzomib Myeloma Access Program (C-MAP)

Providing Access to Individuals with Relapsed and Refractory Multiple Myeloma

 

Onyx Pharmaceuticals and the Multiple Myeloma Research Foundation have established the Carfilzomib Myeloma Access Program (C-MAP), an expanded access program that makes carfilzomib available to eligible patients in the United States with relapsed and refractory multiple myeloma.  Under an Expanded Access Program, the U.S. Food and Drug Administration (FDA) allows seriously ill patients who lack any treatment options to try a promising drug that is still under development.

Interested patients should talk to their physician or ask their physician to call the Onyx Pharmaceuticals Medical Information Hotline at 1-877-ONYX-1-2-1 (1-877-669-9121) to learn if they are eligible for the trial.

 
 
Carfilzomib is an investigational medicine being evaluated in multiple clinical trials to treat patients with multiple myeloma.  Because carfilzomib is not currently approved by the U.S. Food and Drug Administration, the treatment is only available in a clinical trial setting.  Carfilzomib is being developed by Onyx Pharmaceuticals, Inc.

Carfilzomib is a selective, next generation proteasome inhibitor.  The proteasome acts as the cell's recycling center and breaks down proteins that may be dysfunctional or no longer needed.  Carfilzomib blocks the proteasome by disrupting processes related to cancer cell growth and survival, as observed in preclinical studies.

Carfilzomib has shown encouraging activity in a number of clinical trials in multiple myeloma, including newly diagnosed, relapsed and/or relapsed and refractory multiple myeloma.  The most common side effect observed across multiple clinical trials are thrombocytopenia, anemia, lymphopenia, pneumonia and fatigue.

 
C-MAP is a multi-center, open-label study of carfilzomib for patients with relapsed and refractory multiple myeloma.  The trial is a single-arm study, meaning carfilzomib is not being compared to another anti-cancer therapy.  The study is designed to provide access to patients who are refractory to their current therapy, have received at least four prior therapies for multiple myeloma, and are not eligible for any other enrolling company-sponsored carfilzomib study.

Patients will receive carfilzomib at 20/27 mg/m2 on 28-day cycles until disease progression, unacceptable toxicity, or until the drug is commercially available.  Per the treatment protocol, safety and certain efficacy data will be collected.

Upon commercial availability, patients who are receiving carfilzomib through C-MAP will be transitioned to commercially available treatment.  Onyx will provide patient support services to facilitate this transition.  Patients without financial means to access carfilzomib commercially will be assessed for eligibility into Onyx assistance programs.

 
To participate in C-MAP, individuals must meet certain criteria:
  • Patients must have relapsed and refractory myeloma (defined as progression during therapy or within 60 days after completion of therapy).
  • Patients must have received at least four prior therapies for multiple myeloma.
  • Patients may not be eligible for any other enrolling company-sponsored carfilzomib studies.

Exclusion criteria include, but are not limited to:

  • Active infection requiring systemic therapy.
  • Need for concomitant approved or investigational anticancer therapeutic therapy with activity against multiple myeloma, other than dexamethasone.
  • Concomitant use of other investigational agents (e.g., antibiotics or antiemetics).
  • Pregnancy or breast-feeding.
  • Refractory to prior carfilzomib treatment.

Speak to your doctor to find out if you are eligible to participate in the study or call the Onyx Pharmaceuticals Medical Information Hotline at 1-877-ONYX-1-2-1 (1-877-669-9121).

 
Approximately 40 medical centers across the United States will enroll patients in C-MAP, including institutions and investigators who have previous experience administering carfilzomib through a clinical trial, member institutions of the Multiple Myeloma Research Consortium (MMRC) and newly identified institutions.  Remaining clinical sites are expected to open beginning in August through the end of 2011.

Onyx and the MMRF have made every effort to ensure geographical balance of sites to provide as convenient access as possible to patients. Sites currently open for patient enrollment are located in the following cities:

Beverly Hills, CA
Burbank, CA
Duarte, CA
Los Angeles, CA
West Hollywood, CA
Denver, CO
Melbourne, FL
Detroit, MI
Hackensack, NJ
Milwaukee, WI
 

Please contact the Onyx Pharmaceuticals Medical Information Hotline at 1-877-ONYX-1-2-1 (1-877-669-9121) to learn if you are eligible for the trial and to be notified when a site is activated in your area.

 
There is no cost to the patient to participate in C-MAP.  Qualified patients will receive study-related medical evaluationsand the investigational drug at no cost.  Costs related to tests and treatments that are considered standard of care will not be covered by the trial.
 
Carfilzomib is not yet FDA approved and is currently only available in a clinical trial setting.

Onyx expects to complete the submission of a New Drug Application (NDA) to the FDA through an accelerated approval process for the treatment of patients with relapsed and refractory multiple myeloma.

Pending FDA review and potential approval, carfilzomib could be commercially available to patients with relapsed and refractory multiple myeloma durign the first half of 2012.

 
Upon commercial availability, patients who are receiving carfilzomib through C-MAP will be transitioned to commercially available product. Onyx will provide patient support services to facilitate this transition.  Patients without financial means to access carfilzomib commercially will be assessed for eligibility into Onyx assistance programs.
 
Onyx Pharmaceuticals, in partnership with the MMRF, is available to answer questions from physicians, patients and caregivers:
 
Onyx Medical Information Services
Toll Free: 1-877-ONYX-1-2-1 (1-877-669-9121)
International:  1-650-266-2434
Website: www.onyxtrials.com
 
Multiple Myeloma Research Foundation (MMRF)
Phone: 1-203-229-0464
Website:www.themmrf.org
 
The information is for educational purposes only.  It is not intended, nor should it be used for diagnostic or treatment purposes.

© Onyx Pharmaceuticals and Multiple Myeloma Research Foundation, 2011.

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