Status:
COMPLETED
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Amgen
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (...
Eligibility Criteria
Inclusion
- Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group \[IMWG\] diagnostic criteria)
- Transplant ineligibility
- Measurable disease, as defined by 1 or more of the following (assessed within 21 days prior to randomization):
- Serum M-protein ≥ 0.5 g/dL, or
- Urine M-protein ≥ 200 mg/24 hours, or
- In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) \> 100 mg/L (involved light chain) and an abnormal kappa lambda ratio (SFLC kappa lambda ratio \< 0.26 or \> 1.65)
- No prior treatment for multiple myeloma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion
- Multiple myeloma of IgM (immunoglobulin M) subtype
- Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a cumulative dose of 160 mg of dexamethasone
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential)
- Waldenström macroglobulinemia (WM)
- Known amyloidosis
Key Trial Info
Start Date :
July 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2016
Estimated Enrollment :
955 Patients enrolled
Trial Details
Trial ID
NCT01818752
Start Date
July 8 2013
End Date
November 4 2016
Last Update
August 26 2019
Active Locations (213)
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1
California Cancer Associates for Research & Excellence, Inc. (cCARE)
Fresno, California, United States, 93720
2
Marin Cancer Care
Greenbrae, California, United States, 94904
3
Sutter Gould Medical Foundation
Modesto, California, United States, 95357
4
Innovative Clinical Research Institute
Whittier, California, United States, 90603