Active Ingredient History
Lenalidomide (trade name Revlimid) is a derivative of thalidomide introduced in 2004. It is an immunomodulatory agent with anti-angiogenic properties. Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy. Also is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. In addition, Revlimid is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. The mechanism of action of lenalidomide remains to be fully characterized. Lenalidomide inhibited the secretion of pro-inflammatory cytokines and increased the secretion of anti-inflammatory cytokines from peripheral blood mononuclear cells. Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including multiple myeloma. Immunomodulatory properties of lenalidomide include activation of T cells and natural killer (NK) cells, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. In multiple myeloma cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis. Recently was discovered, that protein cereblon (CRBN) is a proximate, therapeutically important molecular target of lenalidomide. Low CRBN expression was found to correlate with drug resistance in multiple myeloma (MM) cell lines and primary MM cells. One of the downstream targets of CRBN identified is interferon regulatory factor 4 (IRF4), which is critical for myeloma cell survival and is down-regulated by (immune-modulatory drugs) treatment. CRBN is also implicated in several effects of immunomodulatory drugs, such as down-regulation of tumor necrosis factor-α (TNF-α) and T cell immunomodulatory activity, demonstrating that the pleotropic actions of the immunomodulatory drugs (IMiDs) are initiated by binding to CRBN. Future dissection of CRBN downstream signaling will help to delineate the underlying mechanisms for IMiD action and eventually lead to development of new drugs with more specific anti-myeloma activities. It may also provide a biomarker to predict IMiD response and resistance. Lenalidomide also inhibited the expression of cyclooxygenase-2 (COX-2) but not COX-1 in vitro. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Lymphoma, Mantle-Cell (approved 2005)
Multiple Myeloma (approved 2005)
Myelodysplastic Syndromes (approved 2005)
Agammaglobulinemia (Phase 2)
Aged (Phase 2)
Amyloidosis (Phase 3)
Anemia (Phase 3)
Anemia, Refractory (Phase 1)
Angiogenesis Modulating Agents (Phase 2)
Antigens, CD (Phase 1)
Antigens, CD20 (Phase 2)
Astrocytoma (Phase 2)
Autistic Disorder (Phase 2)
Autoimmune Pancreatitis (Phase 1)
Blood Protein Disorders (Phase 3)
Bone Marrow Diseases (Phase 1)
Brain Neoplasms (Phase 1)
Burkitt Lymphoma (Phase 2)
Cachexia (Phase 1/Phase 2)
Carcinoma (Phase 2)
Carcinoma, Adenoid Cystic (Phase 1)
Carcinoma, Hepatocellular (Phase 1)
Carcinoma, Non-Small-Cell Lung (Phase 2)
Carcinoma, Ovarian Epithelial (Phase 1)
Carcinoma, Renal Cell (Phase 1/Phase 2)
Carcinoma, Squamous Cell (Phase 2)
Carcinoma, Verrucous (Phase 1)
Central Nervous System Neoplasms (Phase 1/Phase 2)
Chemotherapy, Cancer, Regional Perfusion (Phase 2)
Cholangitis (Phase 1)
Choroid Plexus Neoplasms (Phase 1)
Cognitive Dysfunction (Phase 2)
Colonic Neoplasms (Phase 1)
Colorectal Neoplasms (Phase 2)
Composite Lymphoma (Phase 1/Phase 2)
Conjunctival Neoplasms (Phase 2)
COVID-19 (Phase 4)
Craniopharyngioma (Phase 1)
Crohn Disease (Phase 2)
Cyclin D1 (Phase 2)
Diagnosis (Phase 3)
Diffuse Intrinsic Pontine Glioma (Phase 1)
DNA Mismatch Repair (Phase 1)
Drug Evaluation (Phase 4)
Drug Therapy (Phase 2)
Encephalitis (Phase 2)
Ependymoma (Phase 1)
Epstein-Barr Virus Infections (Phase 2/Phase 3)
Erdheim-Chester Disease (Phase 2)
Fallopian Tube Neoplasms (Phase 1/Phase 2)
Fatigue (Phase 2)
Fever (Phase 2)
Glioblastoma (Phase 2)
Glioma (Phase 2)
Gliosarcoma (Phase 2)
Graft vs Host Disease (Phase 2)
Hamartoma (Phase 1/Phase 2)
Healthy Volunteers (Phase 1)
Hematologic Diseases (Phase 3)
Hematologic Neoplasms (Phase 4)
Hematopoietic Stem Cell Transplantation (Phase 2)
Histiocytic Sarcoma (Phase 2)
Histiocytosis, Langerhans-Cell (Phase 2)
Histiocytosis, Sinus (Phase 2)
HIV Infections (Phase 1/Phase 2)
Hodgkin Disease (Phase 2)
HTLV-I Infections (Phase 1)
Immunoglobulin G4-Related Disease (Phase 1)
Immunoglobulin Light-chain Amyloidosis (Phase 2)
Immunoglobulin Light Chains (Phase 3)
Infections (Phase 2)
Informed Consent (Phase 2)
Intestinal Neoplasms (Phase 1)
Intraocular Lymphoma (Phase 2)
Kidney Diseases (Phase 2)
Kidney Failure, Chronic (Phase 2)
Kidney Neoplasms (Phase 2)
Learning (Phase 1)
Lenalidomide (Phase 2)
Leukemia (Phase 2)
Leukemia, B-Cell (Phase 2)
Leukemia, Biphenotypic, Acute (Phase 1)
Leukemia, Eosinophilic, Acute (Phase 2)
Leukemia, Hairy Cell (Phase 2)
Leukemia, Large Granular Lymphocytic (Phase 2)
Leukemia, Lymphocytic, Chronic, B-Cell (Phase 3)
Leukemia, Lymphoid (Phase 2)
Leukemia-Lymphoma, Adult T-Cell (Phase 2)
Leukemia, Monocytic, Acute (Phase 2)
Leukemia, Myeloid (Phase 2)
Leukemia, Myeloid, Acute (Phase 4)
Leukemia, Myelomonocytic, Acute (Phase 2)
Leukemia, Myelomonocytic, Chronic (Phase 3)
Leukemia, Plasma Cell (Phase 1/Phase 2)
Leukemia, Prolymphocytic (Phase 2)
Leukemia, Prolymphocytic, B-Cell (Phase 1)
Liver Neoplasms (Phase 2)
Lupus Erythematosus, Cutaneous (Phase 4)
Lymphadenopathy (Phase 2)
Lymphocytosis (Phase 2)
Lymphoma (Phase 3)
Lymphoma, B-Cell (Phase 2)
Lymphoma, B-Cell, Marginal Zone (Phase 3)
Lymphoma, Follicular (Phase 4)
Lymphoma, Large B-Cell, Diffuse (Phase 3)
Lymphoma, Large-Cell, Anaplastic (Phase 2)
Lymphoma, Large-Cell, Immunoblastic (Phase 2)
Lymphoma, Mantle-Cell (Phase 3)
Lymphoma, Non-Hodgkin (Phase 3)
Lymphoma, Primary Effusion (Phase 1/Phase 2)
Lymphoma, T-Cell (Phase 4)
Lymphoma, T-Cell, Cutaneous (Phase 2)
Lymphoma, T-Cell, Peripheral (Phase 4)
Lymphomatoid Granulomatosis (Phase 2)
Lymphomatoid Papulosis (Phase 2)
Medulloblastoma (Phase 1)
Melanoma (Phase 3)
Meningioma (Phase 1)
Mouth Neoplasms (Phase 1)
Multiple Myeloma (Phase 4)
Mycosis Fungoides (Phase 1/Phase 2)
Myelodysplastic Syndromes (Phase 3)
Myeloproliferative Disorders (Phase 2)
Nasopharyngeal Carcinoma (Phase 1)
Neoplasm Metastasis (Phase 3)
Neoplasms (Phase 3)
Neoplasms by Histologic Type (Phase 2)
Neoplasms, Germ Cell and Embryonal (Phase 1)
Neoplasms, Plasma Cell (Phase 3)
Nerve Degeneration (Phase 1)
Neuroblastoma (Phase 1)
Neurodegenerative Diseases (Phase 2)
Neuroectodermal Tumors (Phase 1)
Neuroendocrine Tumors (Phase 1)
Neurofibromatosis 1 (Phase 2)
Neutropenia (Phase 1)
N-Myc Proto-Oncogene Protein (Phase 1/Phase 2)
Oligodendroglioma (Phase 1)
Oncogenes (Phase 2)
Ovarian Neoplasms (Phase 1/Phase 2)
Pain (Phase 3)
Pancreatic Neoplasms (Phase 2)
Paraproteinemias (Phase 3)
Peripheral Nerve Injuries (Phase 2)
Plaque, Amyloid (Phase 2)
Plasma (Phase 2)
Plasma Cells (Phase 3)
Plasmacytoma (Phase 3)
POEMS Syndrome (Phase 2)
Polycythemia Vera (Phase 2)
Primary Myelofibrosis (Phase 2)
Prostatic Neoplasms (Phase 3)
Radiculopathy (Phase 2/Phase 3)
Rectal Neoplasms (Phase 1)
Recurrence (Phase 2)
Reflex Sympathetic Dystrophy (Phase 2)
Renal Insufficiency (Phase 2)
Retroperitoneal Fibrosis (Phase 1)
Rhabdoid Tumor (Phase 1)
Safety (Phase 4)
Salivary Gland Neoplasms (Phase 1)
Sarcoma, Kaposi (Phase 2)
Sezary Syndrome (Phase 2)
Smoldering Multiple Myeloma (Phase 2)
Splenomegaly (Phase 2)
Squamous Cell Carcinoma of Head and Neck (Phase 1)
Stem Cells (Early Phase 1)
Stem Cell Transplantation (Phase 1/Phase 2)
Sweat (Phase 2)
Testicular Neoplasms (Phase 2)
Therapeutic Uses (Phase 3)
Thrombocythemia, Essential (Phase 2)
Thrombocytopenia (Phase 2)
Thyroid Neoplasms (Phase 2)
Tongue Neoplasms (Phase 1)
Transplantation (Phase 1/Phase 2)
Urethral Neoplasms (Phase 1)
Urinary Bladder Neoplasms (Phase 2)
Waldenstrom Macroglobulinemia (Phase 2)
Weight Loss (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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