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Thalidomide Celgene

Phase 1

Multiple Myeloma | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Nov 12, 2019

Thalidomide Celgene development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2013

Thalidomide Celgene target and mechanism

Molecular targetCRBN, DDB1, CUL4A, RBX1
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL468

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Thalidomide Celgene clinical trials

Thalidomide Celgene · 1 trial · 1 indication

Phase 1 1
NCT01937442Pharmacokinetic Study of Thalidomide in Subjects With Multiple MyelomaMultiple Myeloma
COMPLETED7 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic parameters for plasma thalidomide: Tmax Cmax AUC t1/2 CL/F V/F
predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose

PK blood sampling for a single day (on Day 5)

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Thalidomide Celgene™ 200mg once dailyEXPERIMENTAL5-day period of thalidomide treatment

Interventions

NameTypeDescription
Thalidomide Celgene™DRUG200mg once daily and by mouth
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Males and females ≥ at 18 the time of signing the informed consent document. * Documented diagnosis of multiple myeloma and receiving thalidomide containing therapy or initiating thalidomide-containing therapy. * Subjects must agree to temporally discontinue all antimyeloma th...

Countries:FranceUnited Kingdom
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Competitive Landscape -Multiple Myeloma 340 trials

Frequently asked questions about Thalidomide Celgene

What is Thalidomide Celgene used for?

Thalidomide Celgene is used in multiple myeloma, a cancer of plasma cells in the bone marrow. It is an oncology small molecule developed by Bristol-Myers Squibb Company under the ticker BMY. The program is in Phase 1 clinical development, so it remains investigational rather than an approved therapy.

What does Thalidomide Celgene target?

Thalidomide Celgene targets CRBN, DDB1, CUL4A, and RBX1. It is classified as an inhibitor that acts on this protein complex. CRBN, or cereblon, is the primary binding partner, and the DDB1, CUL4A, and RBX1 components form the associated E3 ubiquitin ligase complex.

Who makes Thalidomide Celgene?

Thalidomide Celgene is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the sponsor of the clinical program for this oncology asset in multiple myeloma.

What phase is Thalidomide Celgene in?

Thalidomide Celgene is in Phase 1 clinical development for multiple myeloma. It is an investigational small molecule and has not been established as an approved treatment. The program has one completed Phase 1 trial, and no trials are currently active.

What clinical trials is Thalidomide Celgene in?

Thalidomide Celgene has been studied in one completed Phase 1 trial, NCT01937442, titled Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma. The trial enrolled 7 participants across France and the United Kingdom, was uncontrolled, and was not randomized or double blinded.