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Peginterferon

Phase 3

Multiple Myeloma | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Apr 4, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment244

FDA Designations

No designations recorded

Clinical trial landscape

Peginterferon · 1 trial · 1 indication

Phase 3 1
NCT00732641Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)Multiple Myeloma
COMPLETED244 Analytics
PHASE3COMPLETED
Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)
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Study Endpoints

Primary Endpoints

Number of Days With Progression Free Survival (PFS)
Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)

PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse. PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse.

Secondary Endpoints

Number of Days of Overall Survival (OS)
Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)
Number of Participants With Complete Response (CR) to Treatment
Month 9 & Month 18
Number of Participants With Partial Response (PR) to Treatment
Month 9 & Month 18
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Peginterferon α-2bEXPERIMENTALPeginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
No TreatmentNO_INTERVENTIONParticipants will be observed and will receive no treatment.

Interventions

NameTypeDescription
PeginterferonDRUGPeginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must demonstrate willingness to participate in the study and to adhere to dose and visit schedules * Must be ≤85 years of age of either sex, and any race * Must have stage II or III multiple myeloma with a histological confirmation consistent with the diagnosis of multiple my...

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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
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Frequently asked questions about Peginterferon

What is Peginterferon used for in Multiple Myeloma?

Peginterferon is an investigational small molecule being studied as a maintenance therapy for participants with Multiple Myeloma who responded to induction therapy. It is currently in Phase 3 clinical development, though the single completed trial did not lead to an approved indication.

Who makes Peginterferon?

Peginterferon is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company sponsored a Phase 3 clinical trial of the drug as a maintenance treatment for Multiple Myeloma.

What phase is Peginterferon in?

Peginterferon is in Phase 3 clinical development for Multiple Myeloma. The Phase 3 trial has been completed, but the drug remains investigational and has not been approved by regulatory authorities for this indication.

What clinical trials is Peginterferon in?

Peginterferon has one completed Phase 3 trial, NCT00732641, titled "Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7)." The trial enrolled 244 participants aged 18 years and older.

Is Peginterferon FDA approved?

Peginterferon is not FDA approved for Multiple Myeloma. It is an investigational drug that completed a Phase 3 clinical trial, but no approval status has been established, and it remains in clinical development.