Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

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 (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

Key facts

Study ID

NCT01818752

Run by

Amgen

People needed

955

Starts

2013-07-08

Expected to finish

2016-11-04

Last updated by the study team

2019-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Marin Cancer Care — Greenbrae, California, United States
• Sutter Gould Medical Foundation — Modesto, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• UF Health Shands Cancer Hospital — Gainesville, Florida, United States
• Evanston KelIogg Cancer Center — Evanston, Illinois, United States
• Billings Clinic Cancer Center — Billings, Montana, United States
• Maimonides Cancer Center — Brooklyn, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Saint Francis Health System — Greenville, South Carolina, United States
• Spartanburg Regional Healthcare System — Spartanburg, South Carolina, United States
• Santee Hematology Oncology — Sumter, South Carolina, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC) — Buenos Aires, Argentina
• Sanatorio Britanico S.A. — Santa Fe, Argentina
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• St. Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
• Central Coast Local Health District — North Gosford, New South Wales, Australia
• Calvary Mater Newcastle — Waratah, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Eastern Health - Box Hill Hospital — Box Hill, Victoria, Australia
• St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Border Medical Oncology — Wodonga, Victoria, Australia
• California Cancer Associates for Research & Excellence, Inc. (cCARE) — Fresno, California, United States

Full record on ClinicalTrials.gov

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