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DRUG:

lenalidomide

i
Other names: CC 5013, CDC 5013, ENMD 0997, IMiD3, CDC 5013, CC-5013, CDC-501, CDC-5013, IMiD-1, IMiD-3, ENMD-0997
Company:
Generic mfg.
Drug class:
TNFα inhibitor, IL-6 inhibitor, IL-12 inhibitor
11h
Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P2, N=41, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed
Trial completion
|
lenalidomide • cytarabine • etoposide IV • mitoxantrone
23h
Hypofractionated radiotherapy combined with lenalidomide improves systemic antitumor activity in mouse solid tumor models. (PubMed, Theranostics)
We demonstrate that lena can augment the hRT-induced abscopal effect in mouse solid tumor models in a CD8 T cell- and IFN-I-dependent manner, correlating with enhanced anti-tumor CD8 T cell immunity, DC cross-presentation, and TA-HEC numbers. Our findings may be helpful for the planning of clinical trials in (oligo)metastatic patients.
Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD70 (CD70 Molecule) • GZMB (Granzyme B) • CD86 (CD86 Molecule)
|
lenalidomide
1d
ACE-LY-003: Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1/2, N=113, Active, not recruiting, Acerta Pharma BV | Phase classification: P1 --> P1/2
Phase classification • Combination therapy
|
Rituxan (rituximab) • lenalidomide • Calquence (acalabrutinib)
1d
SABLe: Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients (clinicaltrials.gov)
P2, N=50, Active, not recruiting, Ida Bruun Kristensen | Recruiting --> Active, not recruiting
Enrollment closed
|
lenalidomide • bortezomib • Xpovio (selinexor) • Neofordex (dexamethasone acetate high-dose)
3d
A Phase I Trial Evaluating the Addition of Lenalidomide to Patients with Relapsed/Refractory Multiple Myeloma Progressing on Ruxolitinib and Methylprednisolone. (PubMed, Target Oncol)
For patients with multiple myeloma, treatment with RUX and MP is effective and well tolerated, and LEN can be used to extend the benefit of this RUX-based treatment.
P1 data • Journal
|
JAK1 (Janus Kinase 1)
|
lenalidomide • Jakafi (ruxolitinib)
4d
SYMPHONY-1: Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov)
P3, N=612, Recruiting, Epizyme, Inc. | Trial completion date: Mar 2029 --> Apr 2032 | Trial primary completion date: Mar 2026 --> Sep 2029
Trial completion date • Trial primary completion date • Combination therapy
|
EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit)
|
EZH2 mutation
|
Rituxan (rituximab) • lenalidomide • Tazverik (tazemetostat)
5d
Identification of Lung Adenocarcinoma Subtypes Based on MHC-II Gene Expression Profile and Immunological Analysis. (PubMed, Int Arch Allergy Immunol)
Overall, MHC-II is not only a potential biomarker for accurately distinguishing LUAD subtypes but also a predictive factor for their survival. Our study offers novel insights into understanding of impact of MHC-II in LUAD and offers a new perspective for improving the accurate classification of LUAD patients and enhancing drug treatment.
Journal • Gene Expression Profile • IO biomarker
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
MHC-II expression
|
lenalidomide
5d
Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1, N=33, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Jun 2022 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy
|
lenalidomide • pomalidomide • Winrevair (sotatercept)
5d
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov)
P1, N=4, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | N=12 --> 4 | Trial completion date: Mar 2034 --> Jun 2029 | Trial primary completion date: Mar 2025 --> Jun 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • lenalidomide • Gazyva (obinutuzumab)
5d
Enrollment open
|
lenalidomide • pomalidomide • Empliciti (elotuzumab)
6d
RV-MM-PI-0691: Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma (clinicaltrials.gov)
P2, N=72, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
TP53 (Tumor protein P53)
|
TP53 mutation
|
lenalidomide • melphalan • Empliciti (elotuzumab)
6d
Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy (clinicaltrials.gov)
P2, N=57, Active, not recruiting, University of Michigan Rogel Cancer Center | Trial completion date: Feb 2026 --> Aug 2026 | Trial primary completion date: Feb 2024 --> Aug 2024
Trial completion date • Trial primary completion date • Minimal residual disease
|
clonoSEQ
|
lenalidomide • bortezomib • Darzalex (daratumumab)
6d
MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients (clinicaltrials.gov)
P2, N=30, Recruiting, St. Joseph's Hospital and Medical Center, Phoenix | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2023 --> Sep 2024
Trial completion date • Trial primary completion date
|
IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • IL1B (Interleukin 1, beta)
|
lenalidomide
6d
Phase 1 study combining elotuzumab with autologous stem cell transplant and lenalidomide for multiple myeloma. (PubMed, J Immunother Cancer)
This phase 1 clinical trial demonstrates that early introduction of immunotherapy after ASCT is well tolerated and shows promising disease control in patients with MM, accompanied by favorable changes in the immune microenvironment.
P1 data • Journal
|
CD34 (CD34 molecule) • SLAMF7 (SLAM Family Member 7)
|
lenalidomide • Empliciti (elotuzumab)
6d
Frontline Lenalidomide for AL Amyloidosis Involving Myocardium (clinicaltrials.gov)
P3, N=2, Completed, Seoul National University Hospital | Unknown status --> Completed | N=30 --> 2
Trial completion • Enrollment change
|
NPPB (Natriuretic Peptide B)
|
lenalidomide
6d
SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
P2, N=95, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
7d
Trial primary completion date
|
CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule)
|
CD20 expression
|
lenalidomide • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb)
7d
Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab (clinicaltrials.gov)
P2, N=67, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
Trial completion date • Trial primary completion date
|
Opdivo (nivolumab) • lenalidomide • bortezomib • pomalidomide • Empliciti (elotuzumab)
7d
A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov)
P1, N=19, Active, not recruiting, Massachusetts General Hospital | Phase classification: P1b --> P1 | Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Sep 2024
Phase classification • Trial completion date • Trial primary completion date • Epigenetic controller
|
lenalidomide • Hiltonol (poly-ICLC) • PVX-410 • citarinostat (ACY-241)
8d
Id and Rd Maintenance Regimens After Induction of Remission in Multiple Myeloma. (clinicaltrials.gov)
P=N/A, N=420, Recruiting, RenJi Hospital | Not yet recruiting --> Recruiting
Enrollment open
|
lenalidomide • Ninlaro (ixazomib)
9d
Combination therapy with venetoclax and azacitidine for the treatment of myelodysplastic syndromes with DDX41 mutations. (PubMed, Hematology)
Myelodysplastic syndromes (MDS) patients with DEAD-box helicase 41 (DDX41) mutations have been reported to be treated effectively with lenalidomide; however, there are no randomized studies to prove it. We retrospectively analyzed the genetic features and clinical characteristics of these patients. Our findings suggest that MDS patients with DDX41 mutation may benefit from the therapy, for six subjects received this regimen as initial therapy and five of the six subjects achieved complete remission.
Journal • Combination therapy
|
DDX41 (DEAD-Box Helicase 41)
|
DDX41 mutation
|
Venclexta (venetoclax) • lenalidomide • azacitidine
11d
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov)
P1, N=12, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Mar 2024 --> Mar 2025
Trial primary completion date
|
Venclexta (venetoclax) • Imbruvica (ibrutinib) • lenalidomide • Gazyva (obinutuzumab)
12d
Enrollment open • Head-to-Head
|
lenalidomide • Darzalex (daratumumab)
12d
Enrollment change • Combination therapy
|
lenalidomide • Elrexfio (elranatamab-bcmm) • Ogsiveo (nirogacestat)
12d
Testing the Addition of Ixazomib/Placebo to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM Trial (clinicaltrials.gov)
P3, N=1, Active, not recruiting, National Cancer Institute (NCI) | N=510 --> 1 | Trial completion date: Mar 2024 --> Apr 2025 | Trial primary completion date: Mar 2024 --> Aug 2023
Enrollment change • Trial completion date • Trial primary completion date
|
lenalidomide • Ninlaro (ixazomib)
13d
RV-CL-PTCL-PI-003974: Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma (clinicaltrials.gov)
P2, N=30, Active, not recruiting, Northwestern University | Trial completion date: Aug 2023 --> Aug 2024
Trial completion date
|
ALK (Anaplastic lymphoma kinase) • CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • TNFRSF8 (TNF Receptor Superfamily Member 8) • PAX5 (Paired Box 5) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1) • CD5 (CD5 Molecule) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • GZMB (Granzyme B) • MME (Membrane Metalloendopeptidase) • CD7 (CD7 Molecule) • UBR5 (Ubiquitin Protein Ligase E3 Component N-Recognin 5)
|
ALK negative
|
lenalidomide • Istodax (romidepsin)
14d
Trial completion
|
lenalidomide
14d
Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide (clinicaltrials.gov)
P=N/A, N=38, Completed, Qianfoshan Hospital | Recruiting --> Completed | N=60 --> 38 | Trial completion date: May 2024 --> May 2023 | Trial primary completion date: Dec 2023 --> May 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
ABCB1 (ATP Binding Cassette Subfamily B Member 1)
|
lenalidomide
15d
Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Beth Christian | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2)
|
Venclexta (venetoclax) • lenalidomide • Gazyva (obinutuzumab)
15d
Multiple myeloma with IgH::MYC and multiple extramedullary lesions (PubMed, Rinsho Ketsueki)
Complete remission was maintained for over one year with lenalidomide maintenance therapy. A solitary IgH::MYC chromosomal translocation is extremely rare in multiple myeloma and may be associated with high tumor proliferative capacity, multiple extramedullary lesions, and poor prognosis. Combined therapeutic modalities with novel and conventional chemotherapy and radiation might be a promising treatment strategy for patients with this type of multiple myeloma.
Journal
|
SDC1 (Syndecan 1)
|
MYC positive
|
lenalidomide
16d
New P2 trial • Minimal residual disease
|
lenalidomide • bortezomib • Darzalex (daratumumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
16d
Empowering macrophages: the cancer fighters within the tumour microenvironment in mantle cell lymphoma. (PubMed, Front Immunol)
Immunomodulatory drugs like lenalidomide reduce the levels of MCL-associated CD163+ macrophages and enhance macrophage phagocytic activity. Similarly, clinical approaches targeting the CD47 "don't eat me" signalling, in combination with the anti-CD20-antibody rituximab, demonstrate increased macrophage activity and phagocytosis of MCL tumour cells. Cell-based therapies such as chimeric antigen receptor (CAR) T-cell have shown promise but various challenges persist, leading to a potential interest in CAR-macrophages (CAR-M). When macrophages are recruited to the TME, they offer advantages including phagocytic function and responsiveness to microenvironment alterations, suggesting their potential as a manipulable and inducible alternative when CAR T-cell therapies fails in the complex landscape of MCL treatment.
Review • Journal • IO biomarker
|
CD163 (CD163 Molecule)
|
Rituxan (rituximab) • lenalidomide
17d
Ex vivo expansion and activation of Vγ9Vδ2 T cells by CELMoDs in combination with zoledronic acid. (PubMed, Int J Hematol)
Here, we demonstrated that next-generation immunomodulators called cereblon E3 ligase modulators (CELMoDs), as well as lenalidomide and pomalidomide, expanded Th1-like Vδ2+ γδ T cells from PBMCs in the presence of zoledronic acid (ZA). ZA but not these immunomodulatory drugs upregulated BTN3A1 in monocytes. These results suggest that immunomodulatory drugs and ZA have cooperative roles in expansion of Th1-like Vδ2+ γδ T cells, and provide the important knowledge for clinical application of human Vδ2+ γδ T cells as effector cells.
Preclinical • Journal • Combination therapy
|
CRBN (Cereblon) • BTN3A1 (Butyrophilin Subfamily 3 Member A1)
|
lenalidomide • pomalidomide • zoledronic acid
18d
Immunoglobulin G4-related disease and B-cell malignancy due to an IKZF1 gain-of-function variant. (PubMed, J Allergy Clin Immunol)
Heterozygosity for gain-of-function IKZF1 variants underlies autoimmunity/inflammatory diseases, IgG4-RD and B-cell malignancies, the onset of which may occur in adulthood. Clinical and immunological data are similar to those for patients with unexplained IgG4-RD. Patients may therefore benefit from treatments inhibiting pathways displaying IKAROS-mediated overactivity.
Journal
|
CD8 (cluster of differentiation 8) • IKZF1 (IKAROS Family Zinc Finger 1) • CD4 (CD4 Molecule) • B3GAT1 (Beta-1,3-Glucuronyltransferase 1)
|
Rituxan (rituximab) • lenalidomide
18d
A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of "Intermediate Fit" Comparing Upfront Three-Drug Induction Regimens Followed by Double- or Single-Agent Maintenance (SWOG-Spring 2024)
To compare overall survival (OS) in frail or selected intermediate fit NDMM participants treated with VRd-Lite induction followed by lenalidomide maintenance (Arm 1) versus DRd induction followed by lenalidomide and daratumumab and hyaluronidase fihj maintenance (Arm 3). Among the three evaluable patients on the DRD-R arm, one has experienced a Grade 4 adverse event as maximum grade (hematologic). Among the two evaluable patients on the DRD-DR arm, one has experienced a Grade 4 adverse event as maximum grade (hematologic).
Clinical • P3 data
|
clonoSEQ
|
lenalidomide • Darzalex Faspro (daratumumab/hyaluronidase)
18d
ZUMA-22: Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov)
P3, N=230, Recruiting, Kite, A Gilead Company | Trial completion date: Jan 2031 --> Oct 2030 | Trial primary completion date: Jan 2031 --> Oct 2030
Trial completion date • Trial primary completion date
|
Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • Yescarta (axicabtagene ciloleucel) • bendamustine • fludarabine IV
19d
Trial completion date
|
lenalidomide • bortezomib • Hemady (dexamethasone tablets)
19d
Trial completion date • Combination therapy
|
lenalidomide • azacitidine • Zolinza (vorinostat)
19d
Trial completion date
|
lenalidomide
19d
Combination of acalabrutinib with lenalidomide and rituximab in relapsed/refractory aggressive B-cell non-Hodgkin lymphoma: a single-arm phase II trial. (PubMed, Nat Commun)
Overall, these results show a significant efficacy of the R2A regimen in patients with aggressive R/R B-cell NHL, with exploratory biomarkers suggesting potential associations with response. (ClinicalTrials.gov 51 identifier: NCT04094142).
P2 data • Journal
|
MYD88 (MYD88 Innate Immune Signal Transduction Adaptor)
|
MYD88 mutation
|
Rituxan (rituximab) • lenalidomide • Calquence (acalabrutinib)
19d
New P2 trial
|
lenalidomide • bortezomib • Darzalex (daratumumab) • dexamethasone
20d
Trial completion
|
Rituxan (rituximab) • lenalidomide • Brukinsa (zanubrutinib)