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Pomalidomide

Phase 2

Plasma Cell Myeloma | Small molecule | Oncology |Amgen Inc.|Last Updated: Apr 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03756896Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple MyelomaPHASE2 ACTIVE NOT_RECRUITING 29Jan 25, 2019Jun 30, 2026Apr 30, 20251 United States
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Study Endpoints
Primary Endpoints
≥ Complete response (CR) rates
Up to 2 years after study start

Completed response (CR) rates will be determined for CPd maintenance.

Secondary Endpoints
Progression-free survival (PFS)
From first dose until documented progression or death, assessed at 18 months
Best response on-study
Up to 2 years after study start
Objective response rate (ORR) defined as the proportion of treated subjects who achieve a best response of CR, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR)
Up to 2 years after study start
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Carfilzomib, pomalidomide, dexamethasoneEXPERIMENTALPatients receive carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
NameTypeDescription
CarfilzomibDRUGGiven IV
DexamethasoneDRUGGiven PO
PomalidomideDRUGGiven PO
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must meet the following criteria on screening examination to be eligible to participate in the study; all laboratory assessments should be performed within 28 days of initiation of protocol therapy unless otherwise specified; subject is, in the investigator's opinion,...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT03756896studyFirstPostDate: changed