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DFRF4539A

Phase 1

Multiple Myeloma | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

DFRF4539A · 1 trial · 1 indication

Phase 1 1
NCT01432353A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple MyelomaMultiple Myeloma
COMPLETED39 Analytics
PHASE1COMPLETED
A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
approximately 3.5 years
Safety: Maximum tolerated dose/dose-limiting toxicities
approximately 1.5 years
Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A
approximately 3.5 years

Secondary Endpoints

Immunogenicity: Serum antitherapeutic antibody levels
approximately 3.5 years
Pharmacokinetics: Area under the concentration - time curve (AUC)
approximately 3.5 years
Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria
approximately 3.5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTAL -

Interventions

NameTypeDescription
DFRF4539ADRUGmultiple ascending doses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Adult patients; \>/= 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Relapsed or refractory multiple myeloma for which no effective standard therapy exists * One of the prior therapies must have included a proteosome inhibitor or an ...

Countries:United States
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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 DFRF4539A

What is DFRF4539A used for?

DFRF4539A is an investigational small molecule being studied for the treatment of multiple myeloma. It is being developed by Roche Holding AG (RHHBY). The drug is currently in Phase 1 clinical development, meaning it is still being tested in clinical trials and is not yet approved for use.

Who makes DFRF4539A?

DFRF4539A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational drug for multiple myeloma. As of now, DFRF4539A is in Phase 1 development and has not been approved by regulatory authorities.

What phase is DFRF4539A in?

DFRF4539A is in Phase 1 clinical development. It is an investigational drug for multiple myeloma and has not yet been approved. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.

What clinical trials is DFRF4539A in?

DFRF4539A has been studied in one clinical trial, identified as NCT01432353. This was a Phase 1 study in patients with relapsed or refractory multiple myeloma. The trial was conducted in the United States and enrolled 39 participants. The study has been completed.

Is DFRF4539A FDA approved?

DFRF4539A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for multiple myeloma. The drug is being studied in clinical trials to evaluate its safety and efficacy, but it has not yet received regulatory approval.