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



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/5/2018
Start Date:July 8, 2013
End Date:November 4, 2016

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A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

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).


Inclusion Criteria:

1. Newly diagnosed symptomatic multiple myeloma (per International Myeloma Working Group
[IMWG] diagnostic criteria)

2. Transplant ineligibility

3. 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)

4. No prior treatment for multiple myeloma

5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

1. Multiple myeloma of IgM (immunoglobulin M) subtype

2. Glucocorticoid therapy within 14 days prior to randomization that equals or exceeds a
cumulative dose of 160 mg of dexamethasone

3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes)

4. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard
differential)

5. Waldenström macroglobulinemia (WM)

6. Known amyloidosis
We found this trial at
15
sites
Brooklyn, New York 11220
2432
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Brooklyn, NY
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
962
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Seattle, WA
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Billings, Montana 59101
949
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Billings, MT
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6113
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Buenos Aires,
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2044
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Canton, OH
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Evanston, Illinois
1728
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Evanston, IL
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209
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Fresno, CA
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Gainesville, Florida 32608
2104
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Gainesville, FL
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Greenbrae, California 94904
367
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Greenbrae, CA
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Greenville, South Carolina 29601
2019
mi
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Greenville, SC
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Modesto, California 95355
298
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Modesto, CA
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New York, New York 10065
2434
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New York, NY
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Spartanburg, South Carolina 29303
2042
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Spartanburg, SC
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Sumter, South Carolina 29150
2144
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Sumter, SC
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Whittier, California 90603
8
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Whittier, CA
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