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)
Associated Therapies
-

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

Phase 1
Suspended
Conditions
Metastatic Breast Carcinoma
Recurrent Breast Carcinoma
Recurrent Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Breast Adenocarcinoma
Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Refractory Nodal Marginal Zone Lymphoma
Recurrent Mycosis Fungoides
Recurrent Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Interventions
Drug: Belinostat
Drug: Carfilzomib
Drug: Copanlisib Hydrochloride
Biological: Daratumumab
Drug: Fludeoxyglucose F-18
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Biological: Obinutuzumab
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Biological: Rituximab
Drug: Romidepsin
Other: Saline
Biological: Trastuzumab
First Posted Date
2018-02-14
Last Posted Date
2023-09-13
Lead Sponsor
Mayo Clinic
Target Recruit Count
39
Registration Number
NCT03432741
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy

Phase 4
Completed
Conditions
Relapsed and/or Refractory Multiple Myeloma
Interventions
First Posted Date
2018-01-31
Last Posted Date
2022-09-27
Lead Sponsor
Takeda
Target Recruit Count
45
Registration Number
NCT03416374
Locations
🇯🇵

Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan

🇯🇵

Kyorin University Hospital, Mitaka, Tokyo, Japan

🇯🇵

Nippon Medical School Hospital, Bunkyo-ku, Tokyo, Japan

and more 20 locations

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

First Posted Date
2018-01-26
Last Posted Date
2024-05-24
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
265
Registration Number
NCT03412565
Locations
🇺🇸

Cancer Center of Central Connecticut - Southington, Southington, Connecticut, United States

🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

🇺🇸

Avera Medical Group - Oncology & Hematology, Sioux Falls, South Dakota, United States

and more 60 locations

Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma

Phase 2
Active, not recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2017-11-08
Last Posted Date
2022-09-07
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
199
Registration Number
NCT03336073
Locations
🇪🇸

Hospital de León, León, Spain

🇪🇸

H. Ramón y Cajal, Madrid, Spain

🇪🇸

Hospital Universitario de Santiago, Santiago De Compostela, Spain

and more 21 locations

Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.

Phase 2
Active, not recruiting
Conditions
Myeloma
Interventions
First Posted Date
2017-10-19
Last Posted Date
2023-05-06
Lead Sponsor
Oslo University Hospital
Target Recruit Count
53
Registration Number
NCT03314636
Locations
🇸🇪

Skåne University Hospital, Lund, Sweden

🇩🇰

Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

🇩🇰

Odense University Hospital, Odense, Denmark

and more 1 locations

A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma

Phase 2
Active, not recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2017-09-25
Last Posted Date
2024-07-05
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
75
Registration Number
NCT03290950
Locations
🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Westchester, Harrison, New York, United States

🇺🇸

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 4 locations

Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant

Phase 2
Active, not recruiting
Conditions
Smoldering Multiple Myeloma
Interventions
First Posted Date
2017-09-20
Last Posted Date
2023-12-12
Lead Sponsor
International Myeloma Foundation
Target Recruit Count
87
Registration Number
NCT03289299
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

Indiana University Simon Cancer Center, Indianapolis, Indiana, United States

🇺🇸

Levine Cancer Institute, Charlotte, North Carolina, United States

and more 7 locations

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

Phase 3
Active, not recruiting
Conditions
Plasma Cell Myeloma
Interventions
First Posted Date
2017-09-07
Last Posted Date
2024-12-10
Lead Sponsor
Sanofi
Target Recruit Count
302
Registration Number
NCT03275285
Locations
🇺🇸

UCSF MS Center Site Number : 8400002, San Francisco, California, United States

🇺🇸

Spartanburg Medical Center Site Number : 8400003, Spartanburg, South Carolina, United States

🇦🇺

Investigational Site Number : 0360005, Blacktown, New South Wales, Australia

and more 67 locations

Carfilzomib With or Without Rituximab in the Treatment of Waldenstrom Macroglobulinemia or Marginal Zone Lymphoma

Phase 2
Terminated
Conditions
Marginal Zone Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Waldenstrom Macroglobulinemia
Refractory Marginal Zone Lymphoma
Refractory Waldenstrom Macroglobulinemia
Waldenstrom Macroglobulinemia
Interventions
Drug: Carfilzomib
Other: Laboratory Biomarker Analysis
Biological: Rituximab
First Posted Date
2017-08-31
Last Posted Date
2020-01-18
Lead Sponsor
University of Washington
Target Recruit Count
4
Registration Number
NCT03269552
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Panobinostat, Carfilzomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Phase 2
Terminated
Conditions
Refractory Plasma Cell Myeloma
Recurrent Plasma Cell Myeloma
Interventions
Drug: Carfilzomib
Other: Chemosensitivity Assay
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Panobinostat
First Posted Date
2017-08-21
Last Posted Date
2022-05-09
Lead Sponsor
University of Washington
Target Recruit Count
9
Registration Number
NCT03256045
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

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