MedPath

Carfilzomib

Generic Name
Carfilzomib
Brand Names
Kyprolis
Drug Type
Small Molecule
Chemical Formula
C40H57N5O7
CAS Number
868540-17-4
Unique Ingredient Identifier
72X6E3J5AR
Background

Carfilzomib is an injectable antineoplastic agent (IV only). Chemically, it is a modified tetrapeptidyl epoxide and an analog of epoxomicin. It is also a selective proteasome inhibitor. FDA approved carfilzomib in July 2012 for the treatment of adults with relapsed or refractory multiple myeloma as monotherapy or combination therapy.

Indication

Carfilzomib is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with lenalidomide and dexamethasone; or dexamethasone; or daratumumab and dexamethasone; or daratumumab and hyaluronidase-fihj and dexamethasone; or isatuximab and dexamethasone. It is also indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

Associated Conditions
Relapsed/Refractory Multiple Myeloma (RRMM)

Study of Weekly Carfilzomib, Cyclophosphamide and Dexamethasone In Newly Diagnosed Multiple Myeloma Patients (wCCyd)

Phase 1
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2013-05-20
Last Posted Date
2024-11-13
Lead Sponsor
European Myeloma Network B.V.
Target Recruit Count
63
Registration Number
NCT01857115
Locations
🇮🇹

Fondazione EMN Italy Onlus, Torino, Italy

Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 1
Completed
Conditions
DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Interventions
Procedure: Autologous Bone Marrow Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
First Posted Date
2013-04-29
Last Posted Date
2020-09-01
Lead Sponsor
Mayo Clinic
Target Recruit Count
50
Registration Number
NCT01842308
Locations
🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

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

Phase 3
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2013-03-26
Last Posted Date
2019-08-26
Lead Sponsor
Amgen
Target Recruit Count
955
Registration Number
NCT01818752
Locations
🇺🇸

California Cancer Associates for Research & Excellence, Inc. (cCARE), Fresno, California, United States

🇨🇳

Guangdong General Hospital, Guangzhou, Guangdong, China

🇦🇺

The Alfred Hospital, Melbourne, Victoria, Australia

and more 209 locations

Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase 2
Active, not recruiting
Conditions
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions
Procedure: autologous hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
First Posted Date
2013-03-22
Last Posted Date
2024-05-14
Lead Sponsor
University of Chicago
Target Recruit Count
76
Registration Number
NCT01816971
Locations
🇺🇸

Washington University in St Louis, Saint Louis, Missouri, United States

🇺🇸

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

🇨🇦

Princess Margaret, Toronto, Ontario, Canada

and more 2 locations

A Phase II Study of Carfilzomib in Relapsed Waldenström's Macroglobulinemia (WM) IST-CAR-531

Phase 2
Completed
Conditions
Waldenstrom Macroglobulinemia
Interventions
First Posted Date
2013-03-18
Last Posted Date
2022-04-13
Lead Sponsor
Hackensack Meridian Health
Target Recruit Count
7
Registration Number
NCT01813227
Locations
🇺🇸

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant

Phase 2
Withdrawn
Conditions
Stage I Multiple Myeloma
Refractory Multiple Myeloma
Stage III Multiple Myeloma
Stage II Multiple Myeloma
Interventions
Other: laboratory biomarker analysis
First Posted Date
2013-03-18
Last Posted Date
2016-12-19
Lead Sponsor
Mayo Clinic
Registration Number
NCT01812720
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

City of Hope, Duarte, California, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma

Phase 1
Conditions
Multiple Myeloma
Interventions
First Posted Date
2013-02-15
Last Posted Date
2018-03-05
Lead Sponsor
Oncotherapeutics
Target Recruit Count
38
Registration Number
NCT01792102
Locations
🇺🇸

John Theuer Cancer Center Hackensack University Medical Center, Hackensack, New Jersey, United States

🇺🇸

James R. Berenson M.D. Inc., West Hollywood, California, United States

A Safety Study of Carfilzomib in Patients With Previously-Treated Systemic Light Chain Amyloidosis

Phase 1
Completed
Conditions
Amyloidosis
Systemic Light Chain Amyloidosis
Interventions
First Posted Date
2013-02-12
Last Posted Date
2017-10-18
Lead Sponsor
Criterium, Inc.
Target Recruit Count
32
Registration Number
NCT01789242
Locations
🇺🇸

Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

🇺🇸

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 7 locations

Carfilzomib in Refractory Renal Cell Carcinoma (RCC)

Phase 2
Completed
Conditions
Kidney Cancer
Interventions
First Posted Date
2013-01-25
Last Posted Date
2020-03-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
10
Registration Number
NCT01775930
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Study of High Dose Carfilzomib in Multiple Myeloma Patients Who Have Progressed On Standard Dose Carfilzomib

Phase 2
Completed
Conditions
Relapse Multiple Myeloma
Refractory Multiple Myeloma
Interventions
First Posted Date
2013-01-25
Last Posted Date
2017-06-21
Lead Sponsor
Ajai Chari
Target Recruit Count
13
Registration Number
NCT01775553
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

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