Carfilzomib

Also known as: Kyprolis · PR-171

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 10 applications

Randomized controlled trials 72 of 1,860 publications on PubMed

Registered clinical trials 278 96 active

Adverse event reports 28,315 21,817 classified as serious

Carfilzomib is an FDA-approved drug, marketed as Kyprolis, Carfilzomib, Kitprozy (first approval: July 20, 2012).
PubMed lists 1,860 publications mentioning it, including 72 randomized controlled trials and 51 animal-only studies.
ClinicalTrials.gov lists 278 registered studies testing it (96 active).
FDA's adverse event system (FAERS) holds 28,315 reports mentioning it; 21,817 classified as serious. Reports do not prove causation.

Research topics

Multiple Myeloma 84
Antineoplastic Combined Chemotherapy Protocols 48
Proteasome Inhibitors 42
Dexamethasone 36
Antineoplastic Agents 28
Lenalidomide 27
Bortezomib 26
Drug Resistance, Neoplasm 23
Antibodies, Monoclonal 17
Proteasome Endopeptidase Complex 16

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application	Product	Status	First approval	Sponsor
NDA202714	KYPROLIS	Approved, marketed	July 20, 2012	ONYX PHARMS AMGEN
ANDA209422	CARFILZOMIB	Approved, marketed	September 9, 2019	DR REDDYS
ANDA209425	CARFILZOMIB	Approved, discontinued	March 16, 2020	APOTEX
ANDA211185	CARFILZOMIB	Approved, discontinued	March 20, 2020	APOTEX
ANDA209330	CARFILZOMIB	Approved, discontinued	June 11, 2021	BRECKENRIDGE
ANDA209526	CARFILZOMIB	Approved, marketed	July 20, 2026	MSN
ANDA209528	CARFILZOMIB	Tentative approval	—	QILU PHARM CO LTD
ANDA210823	CARFILZOMIB	Tentative approval	—	EUGIA PHARMA
ANDA219276	CARFILZOMIB	Tentative approval	—	HAINAN POLY PHARM. CO., LTD.
NDA220712	KITPROZY	Approved, marketed	—	AMNEAL PHARMS NY

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

All publications 1,860
Human (MeSH) 1,397
Animal only 51
Clinical trials 222
Randomized controlled trials 72
Systematic reviews & meta-analyses 47
Case reports 145
Retracted 5

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Targeting lactate-driven protein lactylation overcomes proteasome inhibitor resistance in multiple myeloma. Human study 2026 Apoptosis : an international journal on programmed cell death
The 19S proteasome as a therapeutic target in hematologic malignancies. Review 2026 Frontiers in cell and developmental biology
Molecular predictors of minimal residual disease in newly diagnosed multiple myeloma treated with quadruplet therapy. Unclassified 2026 Nature medicine
Final results of the CARO study: real-world adherence, effectiveness and patient-reported quality of life with carfilzomib-based regimens in German patients with relapsed/refractory multiple myeloma. Human study 2026 Annals of hematology
Carfilzomib preserves dendritic cell phenotype and function compared with bortezomib. Human study 2026 Frontiers in immunology
Cost-Effectiveness Analysis of Carfilzomib vs Bortezomib in Relapsed/Refractory Multiple Myeloma in Iran. Unclassified 2026 Value in health regional issues
[Evolving strategies for relapsed multiple myeloma: Toward personalized treatment in 2026]. Unclassified 2026 Bulletin du cancer
[Expression Level and Function of UBE2QL1 in Multiple Myeloma]. Human study 2026 Zhongguo shi yan xue ye xue za zhi
Patient-reported Outcomes and Healthcare Provider Perspectives on Subcutaneous Isatuximab Delivery via On-body Injector Versus Manual Injection: Results From the Phase 2 IZALCO Study in Relapsed/Refractory Multiple Myeloma. Unclassified 2026 Clinical lymphoma, myeloma & leukemia
Sequential Autologous Stem Cell Transplantation and Ciltacabtagene Autoleucel for Concurrent Multiple Myeloma and Presumptive Immunoglobulin Heavy- and Light-Chain Amyloidosis in a Patient With Systemic Lupus Erythematosus. Case report 2026 Cureus

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered: 278
Active: 96
With posted results: 91

Conditions studied

Multiple Myeloma 142
Refractory Multiple Myeloma 20
Recurrent Multiple Myeloma 10
Multiple Myeloma in Relapse 10
Recurrent Plasma Cell Myeloma 8
Refractory Plasma Cell Myeloma 8
Lymphoma 8
Relapsed or Refractory Multiple Myeloma 7
Relapsed Multiple Myeloma 7
Plasma Cell Myeloma 6
Myeloma 6
Relapse Multiple Myeloma 5

Study	Status	Phase	Start
Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse NCT06948084 National Cancer Institute (NCI)	Recruiting	Phase 2	May 22, 2027
Testing an Experimental Approach to Treat Patients With Plasma Cell Leukemia, The QUANTUM Trial NCT07605416 National Cancer Institute (NCI)	Recruiting	Phase 2	April 20, 2027
Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment NCT07463807 National Cancer Institute (NCI)	Recruiting	Phase 1, Phase 2	April 12, 2027
A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma NCT07728188 AbbVie	Not yet recruiting	Phase 3	November 30, 2026
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy NCT07715903 National Cancer Institute (NCI)	Not yet recruiting	Phase 1	November 4, 2026
Inobrodib, Pomalidomide and Dexamethasone Versus Standard Available Therapy in Relapsed or Refractory Multiple Myeloma NCT07772024 CellCentric Ltd.	Recruiting	Phase 3	Aug 2026
A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen NCT07709884 The First Affiliated Hospital of Soochow University	Not yet recruiting	Phase 4	July 1, 2026
Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma NCT07555938 Hoffmann-La Roche	Recruiting	Phase 3	June 23, 2026
KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome NCT07652879 Shanghai Changzheng Hospital	Recruiting	Phase 2	June 15, 2026
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel NCT06918990 National Institute of Allergy and Infectious Diseases (NIAID)	Recruiting	Phase 1	May 27, 2026

Show 40 more studies

Study	Status	Phase	Start
Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma NCT07479979 Natalie Callander	Recruiting	Phase 1, Phase 2	May 21, 2026
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM) NCT07227311 GlaxoSmithKline	Recruiting	Phase 2	April 15, 2026
A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4) NCT07391657 AstraZeneca	Recruiting	Phase 3	February 23, 2026
A Phase 2, Single Arm Multicenter, Study Testing Mezigdomide, Carfilzomib, and Dexamethasone (480Kd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) NCT07348393 Assistance Publique - Hôpitaux de Paris	Not yet recruiting	Phase 2	Feb 2026
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) NCT07222761 Regeneron Pharmaceuticals	Recruiting	Phase 3	January 2, 2026
Quality of Life and Treatment Outcomes in RRMM Patients Receiving Advanced vs. Conventional Immunotherapies NCT07051850 Sung-Soo Park	Recruiting	—	July 14, 2025
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations NCT06892522 AbbVie	Recruiting	Phase 1, Phase 2	June 30, 2025
Mezigdomide, Carfilzomib, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma in Patients With Extramedullary Disease NCT06627751 Roswell Park Cancer Institute	Recruiting	Phase 2	May 1, 2025
SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma NCT06622005 Roswell Park Cancer Institute	Recruiting	Phase 1	April 10, 2025
Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease NCT06793475 Institute of Hematology & Blood Diseases Hospital, China	Recruiting	N/A	April 9, 2025
Efficacy of Sequential BCMA CAR-T Cell Therapy Following Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma NCT06913192 Xuzhou Medical University	Not yet recruiting	Phase 1	April 1, 2025
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma NCT06356571 Sanofi	Active, not recruiting	Phase 2	March 17, 2025
A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2) NCT06615479 Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	Recruiting	Phase 3	March 12, 2025
KPD Consolidation After ASCT in NDMM Patients NCT06879379 Peking University People's Hospital	Recruiting	Phase 2, Phase 3	Mar 2025
Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone NCT06561854 Assistance Publique - Hôpitaux de Paris	Recruiting	Phase 3	December 12, 2024
Conversion to Carfilzomib Therapy in Bortezomib Intolerant Newly Diagnosed Multiple Myeloma(NDMM) Patients NCT06682156 The First Affiliated Hospital of Soochow University	Recruiting	—	September 10, 2024
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma NCT06413498 Kite, A Gilead Company	Active, not recruiting	Phase 3	August 23, 2024
ATRA and Carfilzomib in Plasma Cell Myeloma Patients NCT06536413 The Methodist Hospital Research Institute	Recruiting	Phase 1, Phase 2	July 29, 2024
Immunotherapy in Lymphoma NCT06796517 Sung-Soo Park	Recruiting	—	June 26, 2024
Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection NCT06409702 The First Affiliated Hospital of Soochow University	Recruiting	Phase 4	June 12, 2024
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma NCT06158841 AbbVie	Active, not recruiting	Phase 3	May 19, 2024
Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer NCT06249282 City of Hope Medical Center	Recruiting	Phase 1	April 24, 2024
Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma NCT05896228 Benjamin T Diamond, MD	Recruiting	Phase 2	February 20, 2024
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) NCT06152575 Pfizer	Recruiting	Phase 3	February 8, 2024
All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma NCT06158412 The First Affiliated Hospital of Xiamen University	Recruiting	Phase 2	November 22, 2023
Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma NCT06140966 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Phase 2	October 20, 2023
Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for RRMM NCT05909826 Dong-A University Hospital	Not yet recruiting	Phase 2	July 1, 2023
Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma NCT05789303 University of Chicago	Recruiting	Phase 2	May 30, 2023
A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma NCT05704049 Sanofi	Active, not recruiting	Phase 2	April 5, 2023
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab NCT05669989 Sanofi	Enrolling by invitation	Phase 2	April 5, 2023
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma NCT05572515 Janssen Research & Development, LLC	Active, not recruiting	Phase 3	March 29, 2023
A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma NCT05651932 K36 Therapeutics, Inc.	Recruiting	Phase 1	February 22, 2023
COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide NCT05434689 University of Alabama at Birmingham	Active, not recruiting	Phase 1, Phase 2	January 18, 2023
A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2) NCT05552976 Bristol-Myers Squibb	Active, not recruiting	Phase 3	January 10, 2023
A Study of Daratumumab NCT05438043 Janssen Research & Development, LLC	Active, not recruiting	Phase 3	December 15, 2022
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma NCT05675449 Pfizer	Active, not recruiting	Phase 1	December 14, 2022
Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma NCT04756401 Academic and Community Cancer Research United Results posted	Active, not recruiting	Phase 2	December 8, 2022
Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma NCT04933539 National Cancer Institute (NCI)	Active, not recruiting	Phase 2	October 31, 2022
Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial NCT05497804 Mayo Clinic	Active, not recruiting	Phase 2	September 22, 2022
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments NCT05137054 Regeneron Pharmaceuticals	Recruiting	Phase 1	August 17, 2022

All 278 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports: 28,315
Serious: 21,817
With death outcome: 4,402

Most reported reactions

Plasma cell myeloma 3,058
Off label use 2,398
Death 1,768
Fatigue 1,559
Thrombocytopenia 1,551
Pneumonia 1,405
Pyrexia 1,183
Dyspnoea 1,138
Diarrhoea 1,130
Anaemia 1,129
Neutropenia 1,118
Nausea 1,096

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

KYPROLIS HUMAN PRESCRIPTION DRUG Onyx Pharmaceuticals, Inc. June 18, 2025

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.