SUMMIT, N.J., Dec. 7 /PRNewswire-FirstCall/ -- Celgene Corporation announced today that clinical investigators from leading cancer research centers will present data from recent and on-going clinical trials of THALOMID (thalidomide) at the American Society of Hematology 48th Annual Meeting, one of the largest oncology meetings in the world, in Orlando, FL from December 9-12, 2006.
The following clinical and scientific research abstracts on THALOMID will be presented in oral and or poster sessions as an exchange of scientific and clinical information by clinical investigators at the American Society of Hematology proceedings. THALOMID is not approved by FDA or any worldwide regulatory agency as a safe or effective treatment in these diseases as presented at these proceedings.
THALOMID (thalidomide) is only indicated for use as a treatment in combination with dexamethasone for patients with newly diagnosed multiple myeloma. THALOMID is based on response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in survival. Thalidomide is indicated for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalidomide is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Multiple Myeloma (MM): * Dexamethasone + Thalidomide (Dex/Thal) Compared to VAD as a Pre-Transplant Treatment in Newly Diagnosed Multiple Myeloma (MM): A Randomized Trial; Abstract 0057 * First Analysis of the Australasian Leukemia and Lymphoma Group (ALLG) Trial of Thalidomide and Alternate Day Prednisolone Following Autologous Stem Cell Transplantation (ASCT) for Patients with MM (ALLG MM6); Abstract 0058 * Timing of Second Autologous Transplantations in Multiple Myeloma: Results of a Multicenter Sequential Randomized Clinical Trial; Abstract 0059 * Combination of Bortezomib, Melphalan, Prednisone and Thalidomide (VMPT) for Relapsed Multiple Myeloma: Results of a Phase I/II Clinical Trial; Abstract 0407 * VAD-doxil vs. VAD-doxil Plus Thalidomide in Patients with Multiple Myeloma: A Multicenter Randomized Trial of the Greek Myeloma Study Group; Abstract 0794 * A Randomized, Double-Blind, Placebo-Controlled Trial of Thalidomide Plus Dexamethasone Versus Dexamethasone Alone as Primary Therapy for Newly Diagnosed Multiple Myeloma; Abstract 0795 * A Multi-Center Phase I/II Study of Melphalan, Prednisone, Thalidomide and Defibrotide in Advanced Multiple Myeloma Patients; Abstract 3560 * Rapidly Cycled Aggressive Lymphoma-Like Therapy (HD-DTPACE) for Salvage of Patients with Advanced Multiple Myeloma (MM); Abstract 3561 * Time to First Progression, but Not [Beta]2-Microglobulin, Predicts Outcome in Myeloma Patients Who Received Thalidomide as Salvage Therapy; Abstract 3562 * Bendamustine, Thalidomide and Prednisolone (BPT) in Patients with Refractory or Relapsed MM after Autologous SCT or Conventional Chemotherapy: Results of a Phase I Clinical Trial; Abstract 3564 * Pulsed Cyclophoshamide, Thalidomide and Dexamethasone (CTD) in Previously Treated Patients with MM: Long Term Follow up & Disease Control after Subsequent Treatments; Abstract 3565 * Thalidomide-Dexamethasone (Thal-dex) vs Interferon-[alpha]- Dexamethasone (IFN-dex) after ThaDD Induction for Multiple Myeloma (MM): First Analysis of a Prospective Randomized Study; Abstract 3566 * Thalidomide after Induction in Myeloma Patients Candidate to High-Dose Therapy; Abstract 3567 * Polychemotherapy in Combination with Thalidomide Followed by Autologous or Allogeneic Transplantation for Rescue after Autograft or Induction Therapy Failure in Patients with MM; Abstract 3018 * The Prognostic Impact of Complete Remission (CR) Plus Very Good Partial Remission (VGPR) in a Double-Transplantation Program for Newly Diagnosed MM. Combined Results of IFM 99 Trials; Abstract 3077 * Analysis of Outcome after Autologous Stem Transplantation in Patients with Newly Diagnosed Myeloma: Comparison of Different Induction Regimens; Abstract 3079 * Up-Front Thal-Dex and Double Autologous Transplantation (Double TX) for MM: Comparison with Double TX without Added Thalidomide and Prognostic Implications of Chromosome 13 Deletion and Translocation t(4;14); Abstract 3081 * S0204: Melphalan (MEL)-Based Tandem Autotransplants (TAT) for MM with Thal/Dex (TD) Induction and Thalidomide/Prednisone (TP) Maintenance: A Phase II Trial of the Southwest Oncology Group; Abstract 3088 * Tandem Cycle High-Dose Melphalan and Busulfan/Cyclophosphamide Followed by Maintenance Interferon Alpha-2 (IF) with or without Thalidomide (Thal) Is Associated with High Complete and VGP Response Rates, Improved PFS and OS; Abstract 3089 * Retrospective Analysis of Fractionated High-Dose Melphalan (F-MEL) and Bortezomib-Thalidomide-Dexamethasone (VTD) with Autotransplant (AT) Support for Advanced and Refractory MM (AR-MM); Abstract 3102 * Total Therapies (TT) for Newly Diagnosed Patients with MM in High-Risk Disease with Cytogenetic Abnormalities (CA) over the Course of 17 Years; Abstract 3490 * Final Results of a Phase II Study of Bortezomib (Velcade) in Combination with Liposomal Doxorubicin (Doxil) & Thalidomide (VDT) in Patients with Relapsed or Refractory MM; Abstract 3539 * Combination of Bortezomib, Melphalan, Dex and Intermittent Thal (VMDT) for R/R MM and Reduces Serum Levels of Dickkopf-1, RANKL, MIP-1 alpha and Angiogenic Cytokines; Abstract 3541 * Multicenter Phase II Trial of Patients with Refractory or Recurrent MM with Oral Treatment of Thalidomide Combined with Oral Cyclophosphamide, Idarubicin and Dexamethasone; Abstract 3559 * A Randomized Comparison of Dexamethasone + Thalidomide (Dex/Thal) vs Dex + Placebo (Dex/P) in Patients (pts) with Relapsing Multiple Myeloma (MM); Abstract 3563 * Survival Outcomes of Patients Receiving Thalidomide-Dexamethasone for Previously Untreated Multiple Myeloma; Abstract 3569 * A Systematic Review and Meta-Analysis of Thalidomide in Patients with Previously Untreated Multiple Myeloma; Abstract 3570 * An Update on Thalidomide in Total Therapy 2 for ND Pts with MM: Analysis of Subgroups Defined by Standard Prognostic Factors and Gene Expression Profiling-Derived Subgroups; Abstract 3389 * Bortezomib and Thalidomide in Newly Diagnosed Patients with Multiple Myeloma; Abstract 3528 * Single agent Thalidomide in Asymptomatic (Smoldering or Indolent) Myeloma; Abstract 3568 * Uptake of New Therapeutics in MM in Germany Results from a Representative Multicentre Treatment Survey 2006; Abstract 5110 * Clinical Presentation, Prognostic Factors and Treatment Outcome of Multiple Myeloma (MM) in African American (AA) Patients; Abstract 5024 * Thalidomide (HAL) Maintenance Following High-Dose Melphalan with Autologous Stem Cell Transplant (ASCT) for Myeloma; Abstract 5455 * Liposomal Doxorubicin (Myocet) with Bortezomib, Dexamethasone Plus Thalidomide in Refractory Myeloma; Abstract 5087 * Low Dose Thalidomide, Dexamethasone and Clarithromycin (Biaxin) (BLT-D) Following ASCT for MM; Abstract 5442 * Thalidomide Plus Dexamethasone in Untreated Newly Diagnosed Multiple Myeloma Patients and Deep Vein Thrombosis; Abstract 5093 * Thalidomide in Hematology Practice at an UK District General Hospital - A 6 Year Experience; Abstract 5511 * Treatment of Newly Diagnosed Inner City Multiple Myeloma Patients With Zoledronate, Dexamethasone and Low Dose Thalidomide: A Phase II Trial; Abstract 5124 * Thalidomide and Dexamethasone in Newly Diagnosed Multiple Myeloma; Abstract 5120 * Ten-year overall survival analysis of current treatments of relapsed or refractory MM in Canada; Abstract 5517 * Combination Chemotherapy Including Velcade in Patients with Refractory or Relapsed Multiple Myeloma; Abstract 5090 * Neurotoxicity of Bortezomib Therapy in Multiple Myeloma (MM): A Single Center Experience; Abstract 3534 Chronic Lymphocytic Leukemia: * High Frequency of T Regulatory Cells in Patients with B-Cell Chronic Lymphocytic Leukemia (B-CLL) Is Decreased by Thalidomide and Fludarabine Treatment; Abstract 2108 * Combined Thalidomide and Fludarabine Therapy in B-Cell Chronic Lymphocytic Leukemia Patients; Abstract 4975 * Coincidence of CLL and MM in One Patient: An Exceptional or Common Event? Summary of 4 Cases at a Single Center; Abstract 4980 Hereditary Hemorrhagic Telangiectasia * Thalidomide in Chronic Bleeding Secondary to Hereditary Hemorrhagic Telangiectasia and Gastrointestinal Vascular Malformations; Abstract 3927 In - Vitro: * Gene Expression Profiling (GEP) of Myeloma Cells To Predict Attainment (near) CR to Primary Therapy with Thal-Dexamethasone for Newly Diagnosed MM; Abstract 0245 * Thalidomide and gamma-Globin Gene Expression in Adult Primary Erythroid Cells through Increased Intracellular Reactive Oxygen Species Mediated Activation of p38 MAPK Signal Pathway; Abstract 1192 * Clarithromicin Induces Autophagy in Myeloma Cells; Abstract 3509 * Impact of Early Consolidation with Bortez, Thal & Dex on Molecularly - Detectable Disease in MM Patients in CR or VGPR Following Autologous Transplantation: Uncommon Achievement of Molecular Remission Despite Evidence of Tumor Load Reduction by Real Time PCR; Abstract 3100 * CKS1B Over-Expression with Thalidomide-Dexamethasone (Thal-Dex) for Newly Diagnosed Multiple Myeloma (MM) Patients; Abstract 0371 * The Genetic Contribution to the Aetiology of Thalidomide Associated VTE; Abstract 0246 * JNK Regulates DKK1 Expression in Multiple Myeloma Cells; Abstract 3411 * Thalidomide and Platelets: Possible Causes of Hypercoagulability and Thrombocytopenia; Abstract 3969 * TP53 Gene Expression, Correlated with 17p13 Deletion, Is a Significant and Independent Adverse Prognostic Factor in MM Treated with High-Dose Therapy and Auto-Transplants; Abstract 3394 Lymphoma: * Targeting Angiogenesis in Mantle Cell Lymphoma: Correlative Studies of a Phase II Trial of RT-PEPC (Rituximab, Thal & Metronomic Oral Chemotherapy with Prednisone, Etoposide, Procarbazine and Cyclophosph) in R/R Disease; Abstract 2751 Myelodysplastic Syndromes (MDS): * Low Doses of Thalidomide in Low Risk MDS with Transfusion-Dependant Anemia: The GFM THAL-SMD-200 Trial; Abstract 2673 * Treatment of Myelodysplastic Syndromes with del 5q before the Lenalidomide Era: The GFM Experience; Abstract 2678 * Expression of proliferation related genes in myelodysplastic syndromes (MDS) and secondary acute myeloid leukemia (AML) patients with resistance to low dose Vidaza and thalidomide; Abstract 2658 Myelofibrosis with Myeloid Metaplasia (MMM): * Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide (TPC Regimen) in the Treatment of Anemia, Splenomegaly, and Constitutional Symptoms Associated with (MMM); Abstract 2689 * Thalidomide Combined with Prednisone Therapy for Myelofibrosis with Myeloid Metaplasia; Abstract 3623 * A Pilot Study To Test Combination of Gleevec with Thalidomide in Patients with Idiopathic Primary Myelofibrosis, Myelofibrosis with Myeloid Metaplasia and Myelodysplastic Syndromes Who Present with MF; Abstract 4841 * Thalidomide and Primary Myelofibrosis? Report of a Case with Complete Reversal of Bone Marrow Fibrosis and Splenomegaly; Abstract 4905 * A Phase II Trial of Combination Therapy with Thalidomide, Arsenic Trioxide, Dexamethasone, and Ascorbic Acid (TADA) in Pts with Chronic Idiopathic Myelofibrosis (CIMF) or Overlap Myelodysplastic/ Myeloproliferative Diseases (MDS/MPD); Abstract 4886 Safety * Reversibility of Renal Failure in Newly Diagnosed Patients with MM Treated with High-Dose Dex Containing Regimens and the Impact of Novel Agents; Abstract 3586 * RADAR Update on Thalidomide- and Lenalidomide-Associated Venous Thromboembolism: Safety Concerns Persist for MM Despite FDA Approvals in This Setting; Abstract 3310 * Erythropoietin Therapy and Venous Thromboembolic Events in Patients with MM Receiving Chemotherapy with or without Thalidomide; Abstract 3572 * Treatment Associated Venous Thromboembolism (VTE) and Survival in MM Patients; Abstract 3573 * Interruption of Bisphosphonates (BP) Therapy in Multiple Myeloma (MM) Patients and Osteonecrosis of the Jaw (ONJ); Abstract 5026 * Trauma Site Localisation of Extramedullary Plasmacytomata in Thalidomide Treated Myeloma Patients; Abstract 5069 * Thalidomide-Induced Leucopenia in Japanese Patients with Refractory Multiple Myeloma; Abstract 5089 * Weight Adjusted Low-Dose Warfarin Decreases the Incidence of Thalidomide Associated VTE in Pts with MM & Waldenstrom's Macroglobulinemia; Abstract 4101 * Thromboprophylaxis with Aspirin for Newly Diagnosed MM Treated with Thalidomide Plus Dexamethasone: A Preliminary Report; Abstract 5091 Multiple Myeloma
THALOMID(R) (thalidomide) in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma.
The effectiveness of THALOMID is based on response rates. There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival.
Erythema Nodosum Leprosum
THALOMID(R) (thalidomide) is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).
THALOMID(R) (thalidomide) is not indicated as monotherapy for such ENL treatment in the presence of moderate to sever neuritis.
THALOMID(R) (thalidomide) is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
WARNINGS:
1. SEVERE, LIFE THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE [1 CAPSULE (REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY CAN CAUSE SEVERE BIRTH DEFECTS.
BECAUSE OF THIS TOXICITY AND IN AN EFFORT TO MAKE THE CHANCE OF FETAL EXPOSURE TO THALOMID(R) (thalidomide) AS NEGLIGIBLE AS POSSIBLE, THALOMID(R) (thalidomide) IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM APPROVED BY THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM CALLED THE "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S. (R))." UNDER THIS RESTRICTED DISTRIBUTION PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS REGISTERED WITH THE PROGRAM ARE ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT. IN ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO, AND COMPLY WITH THE REQUIREMENTS OF THE S.T.E.P.S. (R) PROGRAM IN ORDER TO RECEIVE PRODUCT.
2. VENOUS THROMBOEMBOLIC EVENTS
THE USE OF THALOMID(R) (thalidomide) IN MULTIPLE MYELOMA RESULTS IN AN INCREASED RISK OF VENOUS THROMBOEMBOLIC EVENTS, SUCH AS DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLUS. THIS RISK INCREASED SIGNIFICANTLY WHEN THALIDOMIDE IS USED IN COMBINATION WITH STANDARD CHEMOTHERAPEUTIC AGENTS INCLUDING DEXAMETHASONE. IN ONE CONTROLLED TRIAL, THE RATE OF VENOUS THROMBOEMBOLIC EVENTS WAS 22.5% IN PATIENTS RECEIVING THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE COMPARED TO 4.9% IN PATIENTS RECEIVING DEXAMETHASONE ALONE (P=0.002). PATIENTS AND PHYSICIANS ARE ADVISED TO BE OBSERVANT FOR THE SIGNS AND SYMPTOMS OF THROMBOEMBOLISM. PATIENTS SHOULD BE INSTRUCTED TO SEEK MEDICAL CARE OF THEY DEVELOP SYMPTOMS SUCH AS SHORTNESS OF BREATH, CHEST PAIN, OR ARM OR LEG SWELLING. PRELIMINARY DATA SUGGEST THAT PATIENTS WHO ARE APPROPRIATE CANDIDATES MAY BENEFIT FROM CONCURRENT PROPHYLACTIC ANTICOAGULATION OR ASPIRIN TREATMENT.
IMPORTANT SAFETY INFORMATION
Hypersensitivity: THALOMID(R) (thalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components.
Nursing mothers: It is not known whether THALOMID(R) (thalidomide) is excreted in human milk. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Peripheral neuropathy: THALOMID(R) (thalidomide) is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially sever, side effect of treatment with thalidomide that may be irreversible.
Other most common adverse events: Multiple Myeloma (THALOMID(R)/dexamethasone): The most frequently reported adverse events were constipation (55%), sensory neuropathy (54%), confusion (28%), hypocalcemia (72%), edema (57%), dyspnea (42%), thrombosis/embolism (23%), and rash/desquamation (30%) (occurring in greater than or equal to 20% of patients and with a frequency greater than or equal to 10% in patients treated with THALOMID(R)/dexamethasone compared with dexamethasone alone). ENL (THALOMID(R)): The most frequently reported adverse events were somnolence (38%), rash (21%), headache (13%), asthenia (8%), impotence (8%), malaise (8%), pain (8%), pruritis (8%), and vertigo (8%) (occurring in greater than or equal to 5% of patients). In placebo-controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels.
THALOMID must be administered in compliance with all of the terms outlined in the S.T.E.P.S. (R) program by prescribers, pharmacists, and patients registered with S.T.E.P.S. (R). Patients should be instructed to not extensively handle or open thalidomide capsules and to maintain storage of capsules in blister packs until ingestion.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at http://www.celgene.com.
This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
Celgene CorporationCONTACT: Robert J. Hugin, President & COO, +1-908-673-9102, or Brian P.Gill, Senior Director PR/IR, +1-908-673-9530, both of Celgene Corporation
Web site: http://www.celgene.com/
