Phase 3
Completed N=955
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov NCT01818752 ↗Enrolled (actual)
955
Serious AEs
45.9%
Results posted
Aug 2017
Primary outcomePrimary: Progression-Free Survival (PFS) — 22.1; 22.3 months — p=0.1590
◆ Published Evidence
Highly cited
129citations · ~18 / year
Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma.
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 (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).
Linked Publications (2)
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Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma.
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Carfilzomib and the cardiorenal system in myeloma: an endothelial effect?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
22.1; 22.3 | 0.1590 |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.8934 |
| SECONDARY Overall Response Rate |
78.8; 84.3 | 0.0218 sig |
| SECONDARY Complete Response Rate |
23.1; 25.9 | 0.1388 |
| SECONDARY Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy |
35.1; 2.5 | < 0.0001 sig |
| SECONDARY European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores |
53.3; 53.9; 56.2; 61.1; 55.3; 62.4 | < 0.0001 sig |
| SECONDARY Number of Participants With Adverse Events |
454; 460; 358; 354; 198; 235 | — |
Eligibility Criteria
Inclusion Criteria
- 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 1.65)
- No prior treatment for multiple myeloma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01818752) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.