CLINICAL TRIAL FACT SHEET
Phase 3 Study Comparing Carfilzomib, Lenalidomide,
and Dexamethasone (CRd) vs. Lenalidomide and Dexamethasone (Rd)
in Subjects with Relapsed Multiple Myeloma
This study is currently recruiting participants.
Sponsored by: Onyx Therapeutics, Inc.
Information provided by: Onyx Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01080391
Onyx study ID number: ASPIRE (PX-171-009)
What research question will this study answer?
The study will determine whether the addition of carfilzomib to standard myeloma treatments, lenalidomide
and dexamethasone, will increase the length of time during and after treatment that you are living with
myeloma that does not get worse.
What treatment will be given in the study?
In the study, patients will receive either carfilzomib, lenalidomide and dexamethasone (CRd) or lenalidomide
and dexamethasone (Rd) alone. Patients will continue with treatment unless their myeloma gets worse or they
experience intolerable side effects from the treatment.
What types of patients will take part in the study?
Patients whose myeloma has returned after a period of improvement or after a period during which treatment
was not needed. Patients must have received at least 1 but no more than 3 myeloma drug treatments before
enrolling in the study. Other inclusion/exclusion requirements also apply.
How many patients will take part in the study?
Approximately 700 patients from Europe, North America and Israel
What is the current status of the trial?
The first patient was enrolled in July 2010 in the United States. The trial will be opened in additional countries
over the coming months, including Austria, France, Germany and Italy. The planned time frame for enrolling
patients into the study is approximately 18 months.
Where is the trial taking place?
At participating hospitals, clinics, and doctor practices in various countries. For more information,
please talk to your doctor.
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1010-CARF-036
International Myeloma Foundation
12650 Riverside Drive, Suite 206, North Hol ywood, CA 91607 USA
Telephone: 800-452-CURE (2873) (USA & Canada)
818-487-7455 (worldwide) · TheIMF@myeloma.org · myeloma.org
Additional Information
Study Design: Phase 3, randomized, open-label
Rd=lenalidomide and dexamethasone; CRd=carfilzomib, lenalidomide and dexamethasone;
PO=oral, by mouth; IV=intravenous, into/within a vein; Tx=treatment; LTFU=long-term follow up
Primary Endpoint: Progression-free survival
Sponsor: Onyx Therapeutics, Inc. (a wholly owned subsidiary of Onyx Pharmaceuticals, Inc.)
For further information: email: medinfo@onyx-pharm.com
USA tel: 877-ONYX-121 (877-669-9121)
1010-CARF-036
International Myeloma Foundation
12650 Riverside Drive, Suite 206, North Hol ywood, CA 91607 USA
Telephone: 800-452-CURE (2873) (USA & Canada)
818-487-7455 (worldwide) · TheIMF@myeloma.org · myeloma.org