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A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma


Inclusion Criteria:



- Newly diagnosed symptomatic multiple myeloma

- Transplant-ineligibility

- Males and females ≥ 18 years of age

- Left ventricular ejection fraction (LVEF) ≥ 40%

Exclusion Criteria:

- Waldenstrom macroglobulinemia

- Known amyloidosis

- Plasma cell leukemia

- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and
skin changes)

- Significant neuropathy (Grades ≥ 2) within 14 days prior to randomization

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Description:

To compare Progression Free Survival (PFS) in patients with newly diagnosed multiple myeloma.

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Thierry Facon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chru Lille Service des Maladies du Sang

Authority:

United States: Food and Drug Administration

Study ID:

2012-005

NCT ID:

NCT01818752

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Billings Clinic Billings, Montana  59107-7000
Gabrail Cancer Center Research Canton, Ohio  44718
California Cancer Associates For Research and Excellence, cCARE Fresno, California  93720
Gwinnett Hospital System Inc-d/b/a The Center for Cancer Care Duluth, Georgia  30096