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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01818752Tipo: INTERVENTIONALInicio: 8 de jul de 2013Fin estimado: 4 de nov de 2016

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Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Carfilzomib

Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1.

drug

Bortezomib

Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9.

drug

Melphalan

Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.

drug

Prednisone

Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.

Ubicaciones

Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)

Buenos Aires, Argentina

Sanatorio Britanico S.A.

Santa Fe, Argentina

Patrocinadores

PrincipalAmgen

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