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DRUG:

pomalidomide

i
Other names: CC 4047, CDC 394, CC-4047 , CDC-394, CC4047, CDC394
Company:
Generic mfg.
Drug class:
TNFα inhibitor, IL-6 inhibitor, NK cell stimulant, IL-10 stimulant, IL-1β inhibitor
Related drugs:
6d
Enrollment closed • Enrollment change • Combination therapy
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SDC1 (Syndecan 1)
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pomalidomide • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat)
8d
Long-Term Benefits in Patient-Reported Outcomes and Time to Next Anti-Myeloma Therapy of Ciltacabtagene Autoleucel (Cilta-cel) Versus Standard of Care for Patients with Lenalidomide-Refractory Multiple Myeloma: Results from the Phase 3 Cartitude-4 Clinical Trial (ASH 2024)
"Background: Ciltacabtagene autoleucel (cilta-cel) demonstrated superior progression-free survival (PFS) and overall survival compared to standard of care (SOC; pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone) in patients with lenalidomide-refractory multiple myeloma (MM) after 1-3 prior lines of therapy (LOTs) in the phase 3 CARTITUDE-4 trial. The increase in the TTNT and sustained benefits in PROs, along with prolonged survival, support cilta-cel as a new SOC treatment for MM patients who are refractory to lenalidomide and have received 1-3 prior LOTs. Importantly, with ~3 years of follow-up, a single infusion of cilta-cel provided patients with a longer delay in worsening of MM related symptoms, functional impacts, and GHS/QoL. The totality of clinical and patient-reported evidence demonstrates the significant benefit of cilta-cel."
P3 data • Clinical • Patient reported outcomes
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lenalidomide • bortezomib • Darzalex (daratumumab) • dexamethasone • pomalidomide • Carvykti (ciltacabtagene autoleucel)
8d
Pharmacodynamic Signatures and Correlatives of Response in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Talquetamab or Teclistamab Plus Daratumumab and Pomalidomide (ASH 2024)
P1 | "Tal-DP exhibits a deep, long-term impact on efficacy through complementary mechanisms of action and may be especially beneficial in pts with prior BsAb exposure, who typically have unfavorable BL immune profiles. Ongoing analyses of tec-DP from MajesTEC-2 (NCT04722146) will be presented."
PK/PD data • Clinical
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Darzalex (daratumumab) • pomalidomide • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
14d
Trial primary completion date
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pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
17d
Trial primary completion date
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CD38 positive
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lenalidomide • bortezomib • carfilzomib • dexamethasone • pomalidomide • Tecvayli (teclistamab-cqyv)
17d
New P1/2 trial
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pomalidomide • aspirin
18d
Enrollment open • Enrollment change
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CD4 (CD4 Molecule)
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Xpovio (selinexor) • dexamethasone • pomalidomide • Empliciti (elotuzumab)
23d
R-ICE+X: Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
P2, N=76, Recruiting, Ruijin Hospital | Trial primary completion date: Jun 2024 --> Jun 2025
Trial primary completion date
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carboplatin • Brukinsa (zanubrutinib) • decitabine • Epidaza (chidamide) • pomalidomide • tofacitinib
25d
Phase classification • Combination therapy
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pomalidomide • pavurutamab (AMG 701) • dexamethasone injection
28d
CAMMA 1: A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P1, N=184, Recruiting, Genentech, Inc. | Trial completion date: Jul 2025 --> Jan 2026 | Trial primary completion date: Sep 2024 --> Jan 2026
Trial completion date • Trial primary completion date
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Darzalex (daratumumab) • dexamethasone • pomalidomide • Actemra IV (tocilizumab) • cevostamab (RG6160)
29d
Structure-Activity Relationship of Potent, Selective, and Orally Bioavailable Molecular Glue Degraders of CK1α. (PubMed, ACS Med Chem Lett)
The original molecular glue degraders (thalidomide, lenalidomide, and pomalidomide) are known to bind to cereblon (CRBN) and alter its surface to induce recruitment, ubiquitination, and degradation of therapeutically valuable neosubstrates (IKZF1, IKZF3, and CK1α). Herein, we describe the medicinal chemistry efforts that resulted in the discovery of SJ3149 as well as other potent and selective CK1α degraders. We report kinetic profiling and parameters of CK1α degradation, ternary complex, antiproliferative effects, in vitro ADME data, and in vivo pharmacokinetic studies with demonstrated oral bioavailability.
Journal
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IKZF1 (IKAROS Family Zinc Finger 1) • CRBN (Cereblon) • IKZF3 (IKAROS Family Zinc Finger 3)
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lenalidomide • pomalidomide • thalidomide
1m
Enrollment closed • Enrollment change
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CD4 (CD4 Molecule)
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Xpovio (selinexor) • dexamethasone • pomalidomide • Empliciti (elotuzumab)
1m
Enrollment open
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lenalidomide • dexamethasone • pomalidomide • Elrexfio (elranatamab-bcmm) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
1m
MicroRNA-Triggered Programmable DNA-Encoded Pre-PROTACs for Cell-Selective and Controlled Protein Degradation. (PubMed, Angew Chem Int Ed Engl)
Using miRNA-21 as a model, we engineered DNA hairpins labeled with JQ-1 and pomalidomide and facilitated the modular assembly of DNA-encoded pre-PROTACs through a hybridization chain reaction. The integration of near-infrared light-mediated photodynamic therapy through an upconversion nanosystem further enhanced the efficacy of the platform with potent in vivo anticancer activity. We anticipate that miRiaTAC represents a significant intersection between dynamic DNA nanotechnology and PROTAC, potentially expanding the versatility of PROTAC toolkit for cancer therapy.
Journal
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CDK6 (Cyclin-dependent kinase 6) • MIR21 (MicroRNA 21) • BRD4 (Bromodomain Containing 4)
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JQ-1 • pomalidomide
1m
Enrollment closed • Enrollment change
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carfilzomib • dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc)
2ms
Enrollment change • Combination therapy
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dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • evorpacept (ALX148) • Blenrep (belantamab mafodotin-blmf) • SAR439459 • pegenzileukin (SAR444245)
2ms
Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients with Refractory Multiple Myeloma (clinicaltrials.gov)
P2, N=38, Active, not recruiting, Mayo Clinic | Trial completion date: Oct 2025 --> Oct 2024 | Trial primary completion date: Oct 2024 --> Feb 2024
Trial completion date • Trial primary completion date
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pomalidomide • Empliciti (elotuzumab) • Hemady (dexamethasone tablets) • dexamethasone injection
2ms
Phase classification • Combination therapy
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dexamethasone • pomalidomide • oprozomib (ONX 0912)
2ms
New P3 trial • CAR T-Cell Therapy
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lenalidomide • cyclophosphamide • Darzalex (daratumumab) • carfilzomib • dexamethasone • pomalidomide • fludarabine IV • BMS-986393
2ms
Pomalidomide in patients with multiple myeloma: potential impact on the reconstitution of a functional T-cell immunity. (PubMed, Immunol Res)
These observations imply that Pomalidomide treatment influences the T-cell repertoire, particularly in the CD4 + subpopulation during the later stages of treatment, raising speculation about the potential involvement of these lymphocyte expansions in mechanisms related to antitumor immunity.
Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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lenalidomide • bortezomib • pomalidomide
2ms
New P4 trial • Real-world evidence • Real-world
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bortezomib • carfilzomib • dexamethasone • pomalidomide • Duoenda (mitoxantrone liposomal)
2ms
STOMP: Selinexor and Backbone Treatments of Multiple Myeloma Patients (clinicaltrials.gov)
P1/2, N=300, Recruiting, Karyopharm Therapeutics Inc | Active, not recruiting --> Recruiting
Enrollment open • Combination therapy
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lenalidomide • bortezomib • Xpovio (selinexor) • Ninlaro (ixazomib) • Darzalex (daratumumab) • carfilzomib • pomalidomide • Empliciti (elotuzumab) • Blenrep (belantamab mafodotin-blmf) • mezigdomide (CC-92480)
2ms
Enrollment closed
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lenalidomide • pomalidomide • Elrexfio (elranatamab-bcmm) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
Trial completion • Combination therapy
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Imfinzi (durvalumab) • dexamethasone • pomalidomide
2ms
Ixazomib with Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients with Multiple Myeloma (clinicaltrials.gov)
P1/2, N=30, Active, not recruiting, Joseph Tuscano | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
Trial completion date • Trial primary completion date • Combination therapy
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Ninlaro (ixazomib) • pomalidomide
3ms
CheckMate 039: An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma (clinicaltrials.gov)
P1/2, N=316, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Jul 2024
Trial completion • Trial completion date
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Opdivo (nivolumab) • Yervoy (ipilimumab) • Darzalex (daratumumab) • dexamethasone • pomalidomide • lirilumab (BMS-986015)
3ms
Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin's Lymphomas (clinicaltrials.gov)
P2, N=120, Active, not recruiting, Zhejiang DTRM Biopharma | Recruiting --> Active, not recruiting
Enrollment closed
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BCL2 (B-cell CLL/lymphoma 2)
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pomalidomide • DTRM-555 • DTRMWXHS-12
3ms
The TGFβ type I receptor kinase inhibitor vactosertib in combination with pomalidomide in relapsed/refractory multiple myeloma: a phase 1b trial. (PubMed, Nat Commun)
Vactosertib is a safe therapeutic that demonstrates tumor-intrinsic activity and can overcome immunosuppressive challenges within the tumor microenvironment to reinvigorate T-cell fitness. Vactosertib offers promise to improve immunotherapeutic responses in heavily-pretreated MM patients refractory to conventional agents.
P1 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • TGFB1 (Transforming Growth Factor Beta 1)
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pomalidomide • vactosertib (TEW-7197)
3ms
Clinical response and pathway-specific correlates following TIGIT-LAG3 blockade in myeloma: the MyCheckpoint randomized clinical trial. (PubMed, Nat Cancer)
Persons with myeloma were randomized to receive an anti-TIGIT (T cell immunoreceptor) or anti-LAG3 (lymphocyte activation gene) antibody followed by combination with pomalidomide and dexamethasone ( NCT04150965 ). Anti-TIGIT responders had higher CD226 expression, natural killer cell activation and lower CD112 expression. These data demonstrate the clinical activity of TIGIT-LAG3 blockade and identify pathway-specific response correlates in myeloma.
Clinical • Journal • IO biomarker
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PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CD4 (CD4 Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2) • CD226 (CD226 Molecule)
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dexamethasone • pomalidomide
3ms
Enrollment open
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bortezomib • cyclophosphamide • Darzalex (daratumumab) • carfilzomib • dexamethasone • pomalidomide • fludarabine IV • anitocabtagene autoleucel (CART-ddBCMA)
3ms
IPoD-790: Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma Previously Treated With Daratumumab, Lenalidomide and Bortezomib (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Tel-Aviv Sourasky Medical Center | Trial completion date: Oct 2024 --> Sep 2029 | Trial primary completion date: Sep 2024 --> Mar 2026
Trial completion date • Trial primary completion date
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lenalidomide • bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone • pomalidomide
3ms
New P1/2 trial • Combination therapy
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Rituxan (rituximab) • pomalidomide
3ms
Enrollment closed
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lenalidomide • bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone • pomalidomide
3ms
MonumenTAL-2: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov)
P1, N=167, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
Enrollment closed
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carfilzomib • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs)
3ms
Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin's Lymphomas (clinicaltrials.gov)
P2, N=120, Recruiting, Zhejiang DTRM Biopharma | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2)
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pomalidomide • DTRM-555 • DTRMWXHS-12
3ms
Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P2, N=18, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting
Enrollment closed
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Xpovio (selinexor) • carfilzomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
3ms
Trial suspension
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RUNX1 (RUNX Family Transcription Factor 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • SRSF2 (Serine and arginine rich splicing factor 2) • BCOR (BCL6 Corepressor) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • STAG2 (Stromal Antigen 2) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
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Vyxeos (cytarabine/daunorubicin liposomal formulation) • pomalidomide
3ms
Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma (clinicaltrials.gov)
P2, N=34, Recruiting, Emory University | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date
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CD4 (CD4 Molecule)
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pomalidomide • Blenrep (belantamab mafodotin-blmf) • Hemady (dexamethasone tablets)
3ms
Exploring the anti-myeloma potential of composite nanoparticles As4S4/Fe3O4: Insights from in vitro, ex vivo and in vivo studies. (PubMed, Nanomedicine)
NPs attenuated the stem cell-like side population in MM cells, both alone and in the presence of stroma. For a higher clinical response rate, As4S4/Fe3O4 (4:1) observed synergism with dexamethasone and melphalan, while As4S4/Fe3O4 (1:1) showed synergistic effects in combination with bortezomib, lenalidomide and pomalidomide anti-MM agents, providing the framework for further clinical evaluation of composite NPs in MM.
Preclinical • Journal
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CHEK2 (Checkpoint kinase 2) • CHEK1 (Checkpoint kinase 1) • MAPK1 (Mitogen-activated protein kinase 1) • EIF4EBP1 (Eukaryotic translation initiation factor 4E binding protein 1) • CCNB1 (Cyclin B1) • MAPK3 (Mitogen-Activated Protein Kinase 3)
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lenalidomide • bortezomib • dexamethasone • pomalidomide • melphalan
3ms
Transcription factor Ikzf1 associates with Foxp3 to repress gene expression in Treg cells and limit autoimmunity and anti-tumor immunity. (PubMed, Immunity)
Pomalidomide, which degrades IKZF1 and IKZF3, induced IFN-γ overproduction in human Treg cells. Mechanistically, the Foxp3-Ikzf1-Ikzf3 complex competed with epigenetic co-activators, such as p300, for binding to target gene loci via chromatin remodeling. Therefore, the Ikzf1 association with Foxp3 is essential for the gene-repressive function of Foxp3 and could be exploited to treat autoimmune disease and cancer.
Journal
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IFNG (Interferon, gamma) • IKZF1 (IKAROS Family Zinc Finger 1) • IKZF3 (IKAROS Family Zinc Finger 3) • FOXP3 (Forkhead Box P3)
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pomalidomide
3ms
Trial completion date • Combination therapy
|
Imfinzi (durvalumab) • dexamethasone • pomalidomide
3ms
Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P2, N=29, Recruiting, City of Hope Medical Center | Trial completion date: Jun 2024 --> Feb 2027 | Trial primary completion date: Jun 2024 --> Feb 2027
Trial completion date • Trial primary completion date
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pomalidomide • leflunomide