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Carfilzomib for Inj 60 milligram

Phase 2

Multiple Myeloma in Relapse | Small molecule | Oncology |Amgen Inc.|Trials Updated: Sep 26, 2023

Carfilzomib for Inj 60 milligram target and mechanism

Molecular targetPSMD1, PSMB2, PSMB1, PSMB5, PSMB8, PSMB9
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Carfilzomib for Inj 60 milligram clinical trials

Carfilzomib for Inj 60 milligram · 1 trial · 1 indication

Phase 2 1
NCT03155100Carfilzomib + Elotuzumab + Dexamethasone for Relapsed Multiple Myeloma After 1-3 Prior Treatment LinesMultiple Myeloma in Relapse
COMPLETED15 Analytics
PHASE2COMPLETED
Carfilzomib + Elotuzumab + Dexamethasone for Relapsed Multiple Myeloma After 1-3 Prior Treatment Lines
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Study Endpoints

Primary Endpoints

Overall response rate
3 years

The proportion of patients having achieved at least partial response.

Secondary Endpoints

Severe adverse events
3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Carfilzomib, elotuzumab, dexamethasoneEXPERIMENTALCarfilzomib 70 milligram(mg)/m2 iv (56 mg/m2 for first five patients for cycles 1-2) once weekly, on days 1, 8 and 15 (cycles 1-8), from cycle 9 on days 1 and 15 until progression or toxicity; elotuzumab 10 mg/kg iv on days 1,8,15 for cycles 1-2, on days 1and 15 from cycle 3 until progression or toxicity; dexamethasone 40 mg weekly (shared to po and iv)

Interventions

NameTypeDescription
Carfilzomib for Inj 60 milligram (MG)DRUGAll patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
Elotuzumab 400 MGDRUGAll patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
DexamethasoneDRUGAll patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Male or female patients at the age of 18 to below 75 years with the life expectancy of at least three months. 2. Prior confirmed diagnosis of multiple myeloma and measurable disease in blood or urine with at least one of the following: Serum M-protein ≥ 5g/l, Urine M-protein ...

Countries:FinlandSweden
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Frequently asked questions about Carfilzomib for Inj 60 milligram

What is Carfilzomib for Inj 60 milligram used for?

Carfilzomib for Inj 60 milligram is an injectable small molecule being studied for relapsed multiple myeloma. It is given in combination with elotuzumab and dexamethasone in patients who have received one to three prior lines of treatment. The asset is in Phase 2 clinical development.

What does Carfilzomib for Inj 60 milligram target?

Carfilzomib for Inj 60 milligram targets the proteasome subunits PSMD1, PSMB2, PSMB1, PSMB5, PSMB8, and PSMB9. It acts as an inhibitor of these targets, which are part of the ubiquitin-proteasome system involved in protein degradation within cells.

Who is developing Carfilzomib for Inj 60 milligram?

Carfilzomib for Inj 60 milligram is being developed by Amgen Inc., which trades under the ticker AMGN. Amgen is the company responsible for the clinical program of this asset.

What phase is Carfilzomib for Inj 60 milligram in?

Carfilzomib for Inj 60 milligram is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. The program includes one completed Phase 2 trial.

What clinical trials is Carfilzomib for Inj 60 milligram in?

Carfilzomib for Inj 60 milligram has been studied in one completed Phase 2 trial, NCT03155100, titled Carfilzomib + Elotuzumab + Dexamethasone for Relapsed Multiple Myeloma After 1-3 Prior Treatment Lines. The trial enrolled 15 patients in Finland and Sweden and is now completed.