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JNJ-2641585/ VELCADE/ Dexamethasone

Phase 1

Multiple Myeloma | Small molecule | Oncology |Johnson & Johnson|Last Updated: Jan 22, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-2641585/ VELCADE/ Dexamethasone · 1 trial · 1 indication

Phase 1 1
NCT01464112A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple MyelomaMultiple Myeloma
COMPLETED18 Analytics
PHASE1COMPLETED
A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple Myeloma
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Study Endpoints

Primary Endpoints

Determine the dose-limiting toxicity and set the MTD for the combination of JNJ-26481585 and VELCADE-dexamethasone
Maximum of 18 months

Based on the safety analysis of all cohorts using the patients-treated population

Secondary Endpoints

Adverse events
Maximum of 18 months
Clinical laboratory tests
Maximum of 18 months
Overall response rate
Maximum of 18 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTAL -

Interventions

NameTypeDescription
JNJ-2641585 / VELCADE / DexamethasoneDRUGJNJ-26481585: type=range, unit=mg, number=6 to 12, form=capsules, route=oral use, on Days 1, 3, and 5 of each week. VELCADE: type=exact, unit=mg/m2, number=1.3, form=powder for solution for injection, route=subcutaneous use, on Days 1, 4, 8, and 11 of each 21-day cycle (Cycles 1 to 8) and on Days 1, 8, 15, and 22 of each 35-day cycle (Cycles 9-11). Dexamethasone: type=exact, unit=mg, number=20, form=tablets, route=oral use, on the day of and after VELCADE.
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance status score 0-2 * Measurable or secretory multiple myeloma * Relapse or progression of myeloma following prior systemic antineoplastic therapy * Pretreatment clinical laboratory values meeting protocol-specified criteria *...

Countries:France
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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 JNJ-2641585/ VELCADE/ Dexamethasone

What is JNJ-2641585 used for in multiple myeloma?

JNJ-2641585 is an investigational small molecule being studied in combination with VELCADE (bortezomib) and dexamethasone for the treatment of relapsed multiple myeloma. It is in Phase 1 clinical development and has not been approved by the FDA.

What does JNJ-2641585 target?

JNJ-2641585 is a histone deacetylase inhibitor (HDACi). It works by inhibiting histone deacetylase enzymes, which play a role in gene expression and cancer cell growth. This mechanism is being explored in combination with other agents for multiple myeloma.

Who makes JNJ-2641585?

JNJ-2641585 is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ on the New York Stock Exchange. The company is conducting clinical trials to evaluate the drug in combination with VELCADE and dexamethasone for multiple myeloma.

What phase is JNJ-2641585 in?

JNJ-2641585 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials.

What clinical trials is JNJ-2641585 in?

JNJ-2641585 has been studied in one completed Phase 1 clinical trial, identified as NCT01464112. This trial was a dose escalation study evaluating JNJ-2641585 in combination with VELCADE (bortezomib) and dexamethasone in patients with relapsed multiple myeloma. The trial enrolled 18 participants in France.

Is JNJ-2641585 the same as VELCADE?

No, JNJ-2641585 is not the same as VELCADE. VELCADE (bortezomib) is a proteasome inhibitor, while JNJ-2641585 is a histone deacetylase inhibitor. In the clinical trial, JNJ-2641585 was studied in combination with VELCADE and dexamethasone for multiple myeloma.