Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma (CLARION)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Onyx Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier:
NCT01818752
First received: February 12, 2013
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

This is a Phase 3 multicenter, open-label, randomized study in transplant-ineligible subjects with newly diagnosed multiple myeloma. Subjects are randomized to receive 1 of 2 treatment regimens: Carfilzomib, Melphalan and Prednisone (CMP) or Velcade® (Bortezomib), Melphalan and Prednisone (VMP).


Condition Intervention Phase
Multiple Myeloma
Drug: Carfilzomib
Drug: Bortezomib
Drug: Melphalan
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Onyx Pharmaceuticals:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    To compare Progression Free Survival (PFS) in patients with newly diagnosed multiple myeloma.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Complete Response (CR) rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Overall Response Rate (ORR) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Change from baseline in health-related quality of life (HR-QOL) score [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 882
Study Start Date: March 2013
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carfilzomib, Melphalan, Prednisone (CMP)
Carfilzomib 20 mg/m2 IV over 30 to 60 minutes will be administered on Days 1 and 2 of Cycle 1, followed by escalation to 36 mg/m2 IV over 30 to 60 minutes on Days 8, 9, 22, 23, 29, and 30 of Cycle 1. Carfilzomib 36 mg/m2 IV is administered on days 1, 2, 8, 9, 22, 23, 29 and 30 of Cycles 2 to 9. Prednisone 60 mg/m2 will be taken on Days 1-4, all cycles.
Drug: Carfilzomib
Carfilzomib 20 mg/m2 IV over 30 to 60 minutes will be administered on Days 1 and 2 of Cycle 1, followed by escalation to 36 mg/m2 IV over 30 to 60 minutes on Days 8, 9, 22, 23, 29, and 30 of Cycle 1. Carfilzomib 36 mg/m2 IV is administered on days 1, 2, 8, 9, 22, 23, 29 and 30 of Cycles 2 to 9.
Other Name: carfilzomib
Drug: Melphalan Drug: Prednisone
Prednisone 60 mg/m2 will be taken on Days 1-4, all cycles.
Active Comparator: Bortezomib, Melphalan, Prednisone (VMP)
Bortezomib 1.3 mg/m2 IV push or subcutaneous will be administered on Days 1, 4, 8, 11, 22, 25, 29, and 32 of Cycles 1 through 4, and on Days 1, 8, 22, and 29 of Cycles 5 through 9. Prednisone 60 mg/m2 will be taken on Days 1-4, all cycles.
Drug: Bortezomib
Bortezomib 1.3 mg/m2 IV push or subcutaneous will be administered on Days 1, 4, 8, 11, 22, 25, 29, and 32 of Cycles 1 through 4, and on Days 1, 8, 22, and 29 of Cycles 5 through 9.
Other Name: Velcade
Drug: Melphalan Drug: Prednisone
Prednisone 60 mg/m2 will be taken on Days 1-4, all cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818752

Contacts
Contact: Onyx Medical Information 877-669-9121 medinfo@onyx.com

  Show 222 Study Locations
Sponsors and Collaborators
Onyx Therapeutics, Inc.
Investigators
Principal Investigator: Thierry Facon, MD Chru Lille Service des Maladies du Sang
Principal Investigator: Maria Victoria Mateos, MD Hospital Universitario, Salamanca
Principal Investigator: Ruben Niesvizky, MD Weill Medical College of Cornell University
Principal Investigator: Jae Hoon Lee, MD, PhD Gachon University Gil Medical Center
  More Information

No publications provided

Responsible Party: Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier: NCT01818752     History of Changes
Other Study ID Numbers: 2012-005, 2012-005283-97
Study First Received: February 12, 2013
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Melphalan
Prednisone
Alkylating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014