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

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 - CLARION

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44957

Enrollment

Registered

2013-05-17

Start date

2014-06-05

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

Study Treatment Regimens CMP Regimen: 9 cycli of 42 days Cyclus/cycli Days Study Treatment 1 1, 2 Carfilzomib 20 mg/m2 1 8, 9, 22, 23, 29, 30 Carfilzomib 36 mg/m2 2-9 1, 2, 8, 9, 22, 23, 29, 30 Carf

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Newly diagnosed symptomatic multiple myeloma • Transplant-ineligibility • Males and females >= 18 years of age • Left ventricular ejection fraction (LVEF) >= 40%

Exclusion criteria

Exclusion criteria: • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) • Plasma cell leukemia • Waldenström macroglobulinemia (WM) • Known amyloidosis • Significant neuropathy (Grades >= 2) within 14 days prior to randomization

Design outcomes

Primary

Measure	Time frame
Primary Objective: To compare the progression-free survival (PFS) of transplant-ineligible subjects with newly diagnosed multiple myeloma who are treated with carfilzomib, melphalan, and prednisone (CMP) versus those treated with bortezomib (Velcade), melphalan, and prednisone (VMP).	—

Secondary

Measure	Time frame
Secondary Objectives: To compare the following between the treatment groups: 1. Overall survival (OS) 2. Overall response (OR) status 3. Complete response (CR) status 4. Neuropathy Events 5. EORTC QLQ-C30 Global Health Status/QoL scale 6. Safety and tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)