Recent Updates
Recently added Catalysts

POM+ DEX

Phase 1

Multiple Myeloma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 4, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

POM+ DEX · 1 trial · 2 indications

Phase 1 1
NCT01575925Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)Multiple Myeloma
COMPLETED25 Analytics
PHASE1COMPLETED
Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

PK-Area under the plasma concentration time curve (AUC)
Up to 24 times over 7 months
PK-Time to maximum plasma concentration (Cmax)
24 times over 7 months
PK-Apparent total body clearance (CL/F)
24 times up to 7 months
PK-Renal clearance (CLr)
24 times over 7 months
PK-Apparent volume of distribution (V/F)
24 times over 7 months
PK-Effective terminal half-life (T1/2)
24 times over 7 months

Secondary Endpoints

Number of participants with adverse events (AEs)
Up to 5 years
Number of participants alive
Up to 5 years
Time to response
Up to 5 years
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
4 mg Oral POM + 40 mg Oral DEXEXPERIMENTALOral POM at 4 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle
2 mg Oral POM + 40 mg Oral DEXEXPERIMENTALOral POM at 2 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle

Interventions

NameTypeDescription
4 mg Oral POM + 40 mg Oral DEXDRUG -
2 mg Oral POM + 40 mg Oral DEXDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Must be ≥ 18 years at the time of signing the informed consent form 2. Must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures 3. Must be abl...

Countries:United StatesCanada
Unlock Eligibility Criteria

Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
Unlock Competitive Intelligence

Frequently asked questions about POM+ DEX

What is POM+ DEX used for in Multiple Myeloma?

POM+ DEX is a combination of pomalidomide and dexamethasone being studied for use in patients with Multiple Myeloma, specifically those with impaired renal function. It is an investigational small molecule therapy in Phase 1 clinical development, and it is not yet approved by the FDA.

Who makes POM+ DEX?

POM+ DEX is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research to evaluate the pharmacokinetics and safety of this combination therapy in patients with Multiple Myeloma and renal impairment.

What phase is POM+ DEX in?

POM+ DEX is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the pharmacokinetics and safety of pomalidomide in patients with Multiple Myeloma and impaired renal function. The drug remains investigational and is not FDA approved.

What clinical trials is POM+ DEX in?

POM+ DEX has one completed clinical trial, NCT01575925, titled "Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)." This Phase 1 study enrolled 25 participants in the United States and Canada.

Is POM+ DEX the same as pomalidomide and dexamethasone?

POM+ DEX refers to the combination of pomalidomide and dexamethasone. The clinical trial NCT01575925 evaluates pomalidomide in patients with Multiple Myeloma and renal impairment, with dexamethasone as part of the treatment regimen. This combination is being studied for its safety and pharmacokinetics.