Phase 3 Study of Carfilzomib, Melphalan, and Prednisone versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma (CLARION)

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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222473

Enrollment

882

Registered

2014-04-24

Start date

2014-04-24

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Multiple Myeloma

Interventions

investigational material(s) Generic name etc : Carfilzomib (ONO-7057), Melphalan and Prednisone INN of investigational material : Carfilzomib, Melphalan and Prednisone Therapeutic category code : 429

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed symptomatic multiple myeloma 2.Transplant-ineligibility 3.Left ventricular ejection fraction (LVEF) >= 40%

Exclusion criteria

Exclusion criteria: 1.Waldenstrom's Macroglobulinemia. 2.Known amyloidosis 3.Plasma cell leukemia 4.POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 5.Significant neuropathy (Grades >= 2) within 14 days prior to randomization

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) which will be based on the validated computer algorithm (Onyx Response Computational Assessment, ORCA) assessed outcomes.	—

Secondary

Measure	Time frame
Overall Survival (OS), Complete response rate (CRR), Overall response rate (ORR), Change from baseline in HRQoL score	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026