Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma
An Open-label, Single-arm, Phase 2 Study of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma
1 other identifier
interventional
312
2 countries
34
Brief Summary
To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma. Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Aug 2007
Typical duration for phase_2 multiple-myeloma
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedFirst Posted
Study publicly available on registry
August 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
December 9, 2013
CompletedAugust 31, 2017
August 1, 2017
3.3 years
August 1, 2007
September 27, 2013
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Overall Response Rate (ORR)
For both A0 and A1, to evaluate the best overall response rate (stringent complete response \[sCR\]+ complete response \[CR\]+ very good partial response \[VGPR\]+ partial response \[PR\]) in patients with multiple myeloma who had previously received bortezomib and either thalidomide or lenalidomide, had relapsed after two or more therapies, and were refractory to the most recently received therapy
A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.
Secondary Outcomes (9)
Clinical Benefit Response (CBR) (A0 Only)
Response assessments same as described in primary outcome measure
Clinical Benefit Response (CBR) (A1 Only)
Response assessments same as described in primary outcome measure
Duration of Response (A0 Only)
Response assessments same as described in primary outcome measure
Duration of Response (A1 Only)
Response assessments same as described in primary outcome measure
Time to Progression (A0 Only)
Response assessments same as described in primary outcome measure
- +4 more secondary outcomes
Study Arms (2)
carfilzomib (A0)
EXPERIMENTALcarfilzomib (A1)
EXPERIMENTALInterventions
Subjects will receive carfilzomib 20 mg/m2 as an intravenous bolus over 2 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. A maximum of 12 cycles will be administered.
Eligibility Criteria
You may qualify if:
- Disease Related
- Multiple myeloma
- Subjects must have measurable disease defined as one of the following:
- Serum M-protein ≥ 1 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- Serum FLC ≥ 10 mg/dL with abnormal ratio (A0 Only)
- Quantitative immunoglobulin levels using nephelometry or turbidometry (only if protein electrophoresis was felt to be unreliable for M-protein measurement) (A0 Only)
- Subjects must have been responsive (i.e., achieved an MR or better) to first-line, standard of care therapy
- Refractory to the most recently received therapy. Refractory disease is defined as ≤ 25% response or progression during therapy or within 60 days after completion of therapy.
- Subjects must have received ≥ 2 prior regimens for relapsed disease. Induction therapy and stem cell transplant will be considered as one regimen (A1 Only)
- Subjects must have received prior treatment with bortezomib, and either thalidomide or lenalidomide
- Subjects must have received an alkylating agent either alone or in combination with other myeloma treatments (history of stem cell transplant is acceptable) (A1 Only)
- Subjects must have received an anthracycline either alone or in combination with other myeloma treatments, unless not clinically indicated (A1 Only)
- Demographic
- Males and females \> 18 years of age
- +14 more criteria
You may not qualify if:
- Disease Related
- Multiple Myeloma IgM (A1 Only)
- Subjects who failed to achieve at least a confirmed MR(≥ 25% reduction in M-protein for ≥ 6 weeks) (A1 Only)
- Subjects with non-secretory multiple myeloma, defined as \< 1 g/dL M-protein in serum and \< 200 mg/24 hr M-protein in urine
- Subjects with disease measurable only by serum free light chain (SFLC) analysis (A1 Only)
- Glucocorticoid therapy (prednisone \> 10 mg/day orally or equivalent) within the last three weeks
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia
- Chemotherapy with approved or investigative anticancer therapeutics including steroid therapy within the three weeks prior to first dose
- Radiation therapy or immunotherapy in the previous four weeks; localized radiation therapy within 1 week prior to first dose
- Participation in an investigational therapeutic study within three weeks or within five drug half-lives (t1/2) prior to Day 1, whichever time is greater
- Prior treatment with carfilzomib
- Concurrent Conditions
- Major surgery within three weeks before Day 1
- Congestive heart failure (New York Heart Association class III to IV), symptomatic cardiac ischemia, cardiomyopathy, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction in the previous six months, LVEF \< 40
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (34)
Southern Cancer Center
Mobile, Alabama, 36608, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern Universtiy
Chicago, Illinois, 60605, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
St. Vincent Catholic Medical Center
New York, New York, 10011, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Oncology & Hematology Care
Cincinnati, Ohio, 45236, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Northwest Cancer Center
Houston, Texas, 77090, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Calgary
Calgary, Alberta, T2N 4N2, Canada
University of Alberta, Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Leukemia/BMT Program of BC
Vancouver, British Columbia, V5Z 1M9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2C1, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Related Publications (1)
Siegel DS, Martin T, Wang M, Vij R, Jakubowiak AJ, Lonial S, Trudel S, Kukreti V, Bahlis N, Alsina M, Chanan-Khan A, Buadi F, Reu FJ, Somlo G, Zonder J, Song K, Stewart AK, Stadtmauer E, Kunkel L, Wear S, Wong AF, Orlowski RZ, Jagannath S. A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma. Blood. 2012 Oct 4;120(14):2817-25. doi: 10.1182/blood-2012-05-425934. Epub 2012 Jul 25.
PMID: 22833546DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Onyx Medical Information
- Organization
- Onyx Pharmaceuticals
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2007
First Posted
August 3, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2010
Study Completion
October 1, 2012
Last Updated
August 31, 2017
Results First Posted
December 9, 2013
Record last verified: 2017-08