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Study Complete
Sponsor ID
2012-005

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

Sponsor ID
2012-005
Clinicaltrials.gov ID
NCT01818752
EUCTIS ID
N/A
EudraCT ID
2012-005283-97
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Study Details

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).

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
955
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression-Free Survival

Timeframe: 36 months

Secondary Outcome Measures

Overall Survival (OS)

Timeframe: 36 months

Complete Response (CR) rate

Timeframe: 36 months

Overall Response Rate (ORR)

Timeframe: 36 months

Change from baseline in health-related quality of life (HR-QOL) score

Timeframe: 36 months

Locations

Location
Status
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Location
California Cancer Associates for Research & Excellence, Inc. (cCARE)
Fresno, California, United States, 93720
20.4 miles (32.6 km) away from your location
Status
Active, not recruiting
Study Info
Age
18+ years
Condition
  • Multiple Myeloma
    • Sex
    All
    Trial Dates
    Jul 2013 - Jul 2016
    Inclusion and Exclusion Criteria
    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