TheraRadar
Data updated: May 26, 2026

CARFILZOMIB

Oncology Approved 2019-09-09
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Discontinued
First Approved
2019-09-09
Routes
INTRAVENOUS, INJECTION
Dosage Forms
POWDER, INJECTABLE

Companies

BRECKENRIDGE EUGIA PHARMA MSN PHARMACEUTICALS INC Apotex Dr. Reddy's QILU PHARM CO LTD HAINAN POLY PHARM. CO., LTD.
Active Ingredient: CARFILZOMIB

CARFILZOMIB Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
13 FDA actions from 2019 to 2023
Nov 2023 SUPPL
Label · Labeling
Jun 2021 ORIGINAL
Update
FDA Letter
Mar 2020 ORIGINAL
Update
FDA Letter

What CARFILZOMIB Treats

4 FDA approvals

Originally approved for its first indication in 2019 . Covers 4 distinct patient populations.

  • Other (4)
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Clinical Trial Registry

187 trials
Trial Sponsor ID Phase Status Title
NCT06615479 CA088-1007 Ph 3 recruiting 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)
NCT05497804 MC210811 P50CA186781, 22-002687 Ph 2 active not recruiting Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial
NCT06948084 NCI-2025-02986 NCI-2025-02986, EAA232 Ph 2 not yet recruiting 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
NCT07463807 NCI-2026-01300 NCI-2026-01300, EAA242 Ph 1, Ph 2 not yet recruiting 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
NCT03798678 NCI-2019-00111 NCI-2019-00111, 10219 Ph 1 terminated CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma
NCT06152575 C1071032 MAGNETISMM-32, 2023-507871-23-00 Ph 3 recruiting 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)
NCT05669989 LTS17704 U1111-1277-6635, 2023-507180-19 Ph 2 active not recruiting International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
NCT05060627 GEM-BELMA 2021-002125-15 Ph 1, Ph 2 active not recruiting Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide
NCT06918990 CarBel DAIT CTOT-42 Ph 1 recruiting Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
NCT04973605 BGB-11417-105 2023-507751-30-00, 2021-003614-39 Ph 1, Ph 2 recruiting A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
NCT05050097 MonumenTAL-2 CR108946 64407564MMY1004, 2020-004502-55 Ph 1 active not recruiting A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
NCT07222761 LINKER-MM5 R5458-ONC-2246 2024-519504-27-00 Ph 3 recruiting 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)
NCT05438043 CR109200 54767414MMY3030, 2021-006494-33 Ph 3 recruiting A Study of Daratumumab
NCT06413498 iMMagine-3 KT-US-679-0788 2024-511188-26, jRCT2043240170 Ph 3 recruiting A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
NCT03556332 17-493 Ph 2 active not recruiting A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation
NCT02343042 STOMP KCP-330-017 Ph 1, Ph 2 active not recruiting Selinexor and Backbone Treatments of Multiple Myeloma Patients
NCT04933539 210024 21-C-0024 Ph 2 active not recruiting Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma
NCT07391657 DURGA-4 D8311C00001 AZD0120 Ph 3 recruiting 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)
NCT07227311 224317 2025-523117-28-00 Ph 2 recruiting 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)
NCT07555938 CEVOLUTION CO46096 2025-524028-23-00 Ph 3 not yet recruiting Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma
NCT06622005 I-3850824 Ph 1 recruiting SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
NCT01816971 results posted 12-1725 NCI-2012-02023 Ph 2 completed Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT07082270 I-4514825 NCI-2025-04757, I-4514825 Ph 1 withdrawn Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma
NCT05434689 COMMANDER UAB-21113 Amgen, Inc, BMS Ph 1, Ph 2 active not recruiting COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide
NCT02203643 FORTE UNITO-MM-01 / FORTE Ph 2 completed Evaluation of the Safety and the Efficacy of Carfilzomib Combined With Cyclophosphamide and Dexamethasone (CCyd) or Lenalidomide and Dex (CRd) Followed by ASCT or 12 Cycles of Carf Combined With Dex and Len for Patients Eligible for ASCT With Newly Diagnosed Multiple Myeloma.
NCT03500445 IRB17-1097 Ph 2 active not recruiting Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma
NCT05675449 MagnetisMM-20 C1071020 MAGNETISMM-20 Ph 1 active not recruiting A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma
NCT05572515 MajesTEC-9 CR109244 64007957MMY3006, 2022-000928-37 Ph 3 active not recruiting A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
NCT05017545 ADAPT DAIT ITN089ST ITN089ST, NIAID CRMS ID#: 38685 Ph 1, Ph 2 active not recruiting Carfilzomib and Belatacept for Desensitization
NCT04925193 results posted 20-2202.cc P30CA046934 Ph 2 active not recruiting Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma
NCT02302495 IFM2012-03 2012_32 2012-004490-10 Ph 2 completed Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma
NCT01813227 results posted Pro00003596 CAR-531 Ph 2 completed A Phase II Study of Carfilzomib in Relapsed Waldenström's Macroglobulinemia (WM) IST-CAR-531
NCT06249282 23477 NCI-2023-11093, 23477 Ph 1 recruiting Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer
NCT05552976 SUCCESSOR-2 CA057-008 Ph 3 active not recruiting 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)
NCT04268498 ADVANCE 20201316 2019-001645-41, 19-339 Ph 2 active not recruiting A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma
NCT07479979 BTCRC-MM21-528 Ph 1, Ph 2 recruiting Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
NCT02773030 results posted CC-220-MM-001 U1111-1182-9200, 2016-000860-40 Ph 1, Ph 2 active not recruiting A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma
NCT04883242 RG1121154 NCI-2021-03406, 10690 Ph 2 active not recruiting Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
NCT06158841 CERVINO M22-574 2023-506668-15-00 Ph 3 recruiting Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT05896228 Iber-KDd 20230227 Ph 2 recruiting Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma
NCT01572480 results posted 120107 12-C-0107 Ph 2 completed Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma
NCT03729804 (COBRA) IRB18-1243 Ph 3 active not recruiting Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone (KRd vs. VRd) in Patients With Newly Diagnosed Multiple Myeloma (COBRA)
NCT02659293 IRB15-1286 Ph 3 active not recruiting Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma
NCT04764942 MC1882 NCI-2021-01268 Ph 1, Ph 2 active not recruiting Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, The SCOPE Trial
NCT06356571 SubQSA LPS18183 U1111-1298-7348 Ph 2 recruiting A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT03909412 CarMob Pro2018-0531 Ph 1 recruiting Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma
NCT05199311 Pro2021-0842 Ph 1, Ph 2 recruiting Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Transplant Eligible Multiple Myeloma
NCT06892522 M25-059 2024-515770-27-00 Ph 1, Ph 2 recruiting A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib
NCT04661137 Pro2020-0369 IST-318 Ph 2 suspended A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma
NCT03031730 results posted NCI-2017-00099 NCI-2017-00099, NCI10076 Ph 1 terminated Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma

Showing 50 of 187 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CARFILZOMIB FDA Label Details

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Data Sources

FDA Approval: ANDA209330 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.