Lenalidomide (Revlimid) extends disease-free survival in multiple myeloma patients: StudyLenalidomide (Revlimid) has been demonstrated its ability to considerably prolong disease-free survival in multiple myeloma patients.Lenalidomide (Revlimid) is a derivative of thalidomide.
Results of a large randomized clinical trial for patients with multiple myeloma administered the oral drug lenalidomide appeared to have a prolonged survival rate.The clinical trial, sponsored by the National Cancer Institute (NCI), comprised of patients between ages 18 to 70.The study revealed that those patients on lenalidomide (Revlimid) showed a much longer time before the cancer progressed after autologous blood stem cell transplantation as compared to those on placebo.This led to the lenalidomide (Revlimid) trial being stopped early.
Between 2004 and July 2009, a total of 568 patients with multiple myeloma who had been administered no more than 12 months of earlier therapy and prior transplant before were enrolled for the study.All the subjects were known to have undergone autologous transplantation. In autologous blood stem cell transplantation, patients own blood stem cells are removed to then treat them with high doses of chemotherapy and or radiation therapy to kill the cancer.After this the blood stem cells are returned to the patient. The procedure is common for patients with multiple myeloma.Following this, they were given a high dose of a drug called melphalan that is commonly used to treat multiple myeloma.Between 90 and 100 days after transplant, around 460 patients who showed adequate organ function and apparently no proof of progressive disease were finally randomized to receive lenalidomide or placebo.
Patients started lenalidomide or placebo between day 100 to 110 and appeared to have continued it until they showed evidence of progressive disease.Among the patients who received placebo, half seemed to have their myeloma progress or worsen within an estimated 778 days.While patients taking lenalidomide (Revlimid), a median time to progression could not be defined as less than half the patients appeared to have worsening of their myeloma.For the group taking lenalidomide (Revlimid), it represented a 58 percent decrease in the risk of disease progression.
The study is claimed to be the first randomized phase 3 trial that exhibits a clinical benefit of lenalidomide following transplant for multiple myeloma.“We now know that prolonged maintenance therapy with lenalidomide when compared to placebo will delay disease progression,” stated Philip L. McCarthy, Jr., MD, associate professor of medicine at Roswell Park Cancer Institute and principal investigator of this study.A series of analysis led by the Cancer and Leukemia Group B (CALGB) in partnership with the Eastern Cooperative Oncology Group (ECOG) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) were conducted for the trial.Lenalidomide has been approved by the U.S FDA in 2006 for use in combination with dexamethasone for the treatment of multiple myeloma in patients who received at least one prior therapy for their disease.Multiple myeloma is known to be a cancer of the blood and bone marrow. Multiple myeloma occurs when a kind of immune cell, called a plasma cell, increases in number to crowd out healthy blood cells in the bone marrow. The condition may cause pain, and eventually damage the bones and other body organs. Patients who were part of the current trial were supposedly given the drug after a blood stem cell transplant and seemed to have restrained their cancer.Revlimid is being marketed in US by Celgene International. Recently, Celgene and Revlimid came into controversy, as India’s Dr Reddy’s has alleged that the company is blocking a generic version of the drug under US FDA’s Risk Evaluation and Mitigation Strategy (REMS).Revlimid therapy is known to cause certain birth defects in human if taken during pregnancy. So Revlimid is currently placed under REMS.http://www.dancewithshadows.com/pillscribe/dr-reddys-faces-a-deadlock-on-generic-lenalidomide-launch-in-us-as-celgene-refuses-to-supply-revlimid-samples/
Lenalidomide (Revlimid) has been demonstrated its ability to considerably prolong disease-free survival in multiple myeloma patients.
Lenalidomide (Revlimid) is a derivative of thalidomide.
Results of a large randomized clinical trial for patients with multiple myeloma administered the oral drug lenalidomide appeared to have a prolonged survival rate.
The clinical trial, sponsored by the National Cancer Institute (NCI), comprised of patients between ages 18 to 70.
The study revealed that those patients on lenalidomide (Revlimid) showed a much longer time before the cancer progressed after autologous blood stem cell transplantation as compared to those on placebo.
This led to the lenalidomide (Revlimid) trial being stopped early.
Between 2004 and July 2009, a total of 568 patients with multiple myeloma who had been administered no more than 12 months of earlier therapy and prior transplant before were enrolled for the study.
All the subjects were known to have undergone autologous transplantation. In autologous blood stem cell transplantation, patients own blood stem cells are removed to then treat them with high doses of chemotherapy and or radiation therapy to kill the cancer.
After this the blood stem cells are returned to the patient. The procedure is common for patients with multiple myeloma.Following this, they were given a high dose of a drug called melphalan that is commonly used to treat multiple myeloma.
Between 90 and 100 days after transplant, around 460 patients who showed adequate organ function and apparently no proof of progressive disease were finally randomized to receive lenalidomide or placebo.
Patients started lenalidomide or placebo between day 100 to 110 and appeared to have continued it until they showed evidence of progressive disease.
Among the patients who received placebo, half seemed to have their myeloma progress or worsen within an estimated 778 days.
While patients taking lenalidomide (Revlimid), a median time to progression could not be defined as less than half the patients appeared to have worsening of their myeloma.
For the group taking lenalidomide (Revlimid), it represented a 58 percent decrease in the risk of disease progression.
The study is claimed to be the first randomized phase 3 trial that exhibits a clinical benefit of lenalidomide following transplant for multiple myeloma.
“We now know that prolonged maintenance therapy with lenalidomide when compared to placebo will delay disease progression,” stated Philip L. McCarthy, Jr., MD, associate professor of medicine at Roswell Park Cancer Institute and principal investigator of this study.
A series of analysis led by the Cancer and Leukemia Group B (CALGB) in partnership with the Eastern Cooperative Oncology Group (ECOG) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) were conducted for the trial.
Lenalidomide has been approved by the U.S FDA in 2006 for use in combination with dexamethasone for the treatment of multiple myeloma in patients who received at least one prior therapy for their disease.
Multiple myeloma is known to be a cancer of the blood and bone marrow. Multiple myeloma occurs when a kind of immune cell, called a plasma cell, increases in number to crowd out healthy blood cells in the bone marrow. The condition may cause pain, and eventually damage the bones and other body organs. Patients who were part of the current trial were supposedly given the drug after a blood stem cell transplant and seemed to have restrained their cancer.
Revlimid is being marketed in US by Celgene International. Recently, Celgene and Revlimid came into controversy, as
India’s Dr Reddy’s has alleged
that the company is blocking a generic version of the drug under US FDA’s Risk Evaluation and Mitigation Strategy (REMS).
Revlimid therapy is known to cause certain birth defects in human if taken during pregnancy. So Revlimid is currently placed under REMS.