Articles tagged with: Lenalidomide
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Results from a Spanish Phase 3 study published late Wednesday in the New England Journal of Medicine indicate that treatment of high-risk smoldering multiple myeloma with Revlimid plus dexamethasone delays progression to symptomatic multiple myeloma and extends overall survival.
In addition, the Revlimid (lenalidomide)-dexamethasone (Decadron) regimen had an acceptable safety profile, according to the investigators.
Despite these findings – which would tend to support active treatment of high-risk smoldering myeloma – myeloma experts believe it is too early to begin treating all high-risk smoldering myeloma patients with anti-myeloma therapies.
Dr. María-Victoria …
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Boudry, Switzerland (Press Release) - Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that data evaluating treatment with REVLIMID® (lenalidomide) in combination with dexamethasone followed by REVLIMID maintenance therapy in patients with high-risk asymptomatic smoldering multiple myeloma were published in the August 1 edition of The New England Journal of Medicine. Smoldering multiple myeloma is an early, asymptomatic form of the disease characterized by a 10% per year risk of progression to symptomatic disease over the first five years.
The Phase III, randomized, multicenter, open-label study, led by Maria-Victoria Mateos, …
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The U.S. pharmaceutical company Celgene (NASDAQ: CELG) reported yesterday the discontinuation of the company’s Phase 3 study of Revlimid for chronic lymphocytic leukemia.
Preliminary results from the study, which compared treatment with Revlimid (lenalidomide) to treatment with chlorambucil (Leukeran), showed more deaths among patients being treated with Revlimid than those being treated with chlorambucil.
The study, known as the "ORIGIN" trial, included 421 previously untreated chronic lymphocytic leukemia (CLL) patients at least 65 years of age.
The U.S. Food and Drug Administration (FDA) also determined that the trial results are unlikely …
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Summit, NJ (Press Release) - Celgene Corporation (NASDAQ: CELG) today announced that after consultation with the U.S. Food and Drug Administration (FDA) Celgene will discontinue treatment with REVLIMID® (lenalidomide) in the open-label, phase III ORIGIN® trial, which enrolled 450 patients in over 100 sites in 26 countries. An imbalance was observed in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil.
The FDA placed the ORIGIN study on clinical hold on July 12, 2013, with the discontinuation of lenalidomide treatment. All clinical investigators in ongoing chronic lymphocytic leukemia studies using lenalidomide will be officially …
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Revlimid Plus Dexamethasone Extends Progression-Free Survival In Newly Diagnosed Multiple Myeloma Patients – Results of a large international Phase 3 trial show that Revlimid (lenalidomide) plus dexamethasone (Decadron) extends progression-free survival in newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplantation, compared to treatment with melphalan (Alkeran), prednisone, and thalidomide (Thalomid). Based on these findings, Celgene, the manufacturer of Revlimid, will start the process of applying for approval of Revlimid as frontline treatment in the United States, Europe, and other countries. Although Celgene is widely used in the U.S. for the treatment of newly diagnosed myeloma patients, it is not officially approved for that use in the U.S. or any other country. For more information, please see the related press release from Celgene.
Order Of Velcade And Revlimid Treatment May Not Matter In Treating Myeloma – Results from a recent retrospective study indicate that multiple myeloma patients benefit equally whether they are treated with Velcade (bortezomib) before Revlimid, or vice versa. However, patients with kidney disease tend to benefit from earlier use of Velcade-based therapies. Both Revlimid- and Velcade-based therapies have become common treatment options for myeloma patients. The investigators of this study were interested in determining whether one drug should be given before the other. In their analysis, which was based on data for 208 myeloma patients treated between 2003 and 20089, the authors adjusted for a number of potential biases, such as patient age, number of previous therapies, and whether or not a patient had received a stem cell transplant. The researchers found no significant difference in median overall survival between patients who received Revlimid first versus those who received Velcade first. For more information, please refer to the study in the journal Leukemia Research (abstract).
Unrelated Donor Stem Cell Transplant May Be An Under-Utilized Treatment Option For Myeloma – Findings from a retrospective study suggest that donor stem cell transplants using cells from unrelated donors may be underutilized for myeloma patients, particularly older myeloma patients. Specifically, the researchers found that only 11 percent of the myeloma patients they estimated to be eligible for an unrelated donor transplant actually underwent the procedure. Reasons for not undergoing a transplant included not being referred to a transplant center, worsening health condition of the patient, a prolonged search for a suitable donor, and financial issues. Donor (allogeneic) stem cell transplants involve infusing a patient with donor stem cells after high-dose chemotherapy. While the procedure has the potential to cure myeloma, it also is often accompanied by serious complications, including graft-versus-host-disease (GVHD), in which donor immune system cells recognize the patient's cells as foreign and attack them. For more information, please refer to the study in the journal Biology of Blood and Marrow Transplantation (abstract).
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Researchers at the Medical College of Wisconsin recently found that multiple myeloma patients are at an increased risk of engraftment syndrome following stem cell transplantation, compared to patients with lymphoma. Engraftment syndrome is a complication that can occur soon after stem cell transplantation.
Within the myeloma population, the risk of engraftment syndrome was increased in patients who are over 60 years of age, have been treated with the novel agents Revlimid (lenalidomide) and/or Velcade (bortezomib), or have not been treated with cyclophosphamide (Cytoxan).
“The most important finding is the increased …
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Statistically significant improvement in progression-free survival demonstrated
Boudry, Switzerland (Press Release) - Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID® (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma met its primary endpoint of progression-free survival (PFS). In the study, a doublet regimen of continuous oral lenalidomide in combination with low-dose dexamethasone (Rd) demonstrated a statistically significant improvement in PFS compared to patients receiving a comparator arm with a triplet regimen consisting of melphalan, prednisone and thalidomide (MPT).
One of the largest phase III …
