THALOMID(R) trial results announced
Independent Data Monitoring Committee review determines that the Phase III pivotal trial meets the pre-established efficacy-stopping rule for the primary endpoint of time to disease progression
Celgene Corporation today announced that an external Independent Data Monitoring Committee analysis of the multi-centered, randomized, placebo-controlled phase III study of combination thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma met the pre-specified p<0.0015 value for stopping the trial. The IDMC found time to disease progression -- the primary endpoint of this Phase III trial -- of 75.7 weeks versus 27.9 weeks (p=0.000065), plus progression-free survival of 55.7 weeks versus 24.3 weeks (p=0.0003) in patients receiving THALOMID plus dexamethasone compared to patients receiving dexamethasone alone.
Treatment assignments for patients currently on the trials will be unblinded and those currently not on THALOMID will have the opportunity to add THALOMID to their dexamethasone regimen.
The thalidomide phase III special protocol assessment trial included patients with previously untreated (first-line) multiple myeloma. Patients were randomized to receive thalidomide plus dexamethasone or placebo plus dexamethasone alone. A total of 270 patients were randomized to receive thalidomide plus dexamethasone, or placebo plus dexamethasone, in this multi-centered clinical trial. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.
Patients treated with thalidomide and dexamethasone had an increase in side effects as compared to those patients only treated with placebo plus dexamethasone alone. These adverse drug events included insomnia, tremors, dizziness, peripheral neuropathy and constipation. Grade 3 or 4 adverse events reported included deep vein thrombosis (DVT) occurred in 10.3% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone, and pulmonary embolism (PE) occurred in 5.6% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone.
Safety Notice
THALOMID(R) (thalidomide) Capsules 50 mg, 100 mg, & 200 mg
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 who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the "System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Patients with neoplastic and various inflammatory conditions being treated with thalidomide in combination with other agents may have an increased incidence of thromboembolic events such as pulmonary embolism, deep vein thrombophlebitis, thrombophlebitis, or thrombosis. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide. Patients should be instructed to not extensively handle or open thalidomide capsules and to maintain storage of capsules in blister packs until ingestion.
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.
SOURCE: Celgene Corporation website www.celgene.com
Celgene Corporation today announced that an external Independent Data Monitoring Committee analysis of the multi-centered, randomized, placebo-controlled phase III study of combination thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma met the pre-specified p<0.0015 value for stopping the trial. The IDMC found time to disease progression -- the primary endpoint of this Phase III trial -- of 75.7 weeks versus 27.9 weeks (p=0.000065), plus progression-free survival of 55.7 weeks versus 24.3 weeks (p=0.0003) in patients receiving THALOMID plus dexamethasone compared to patients receiving dexamethasone alone.
Treatment assignments for patients currently on the trials will be unblinded and those currently not on THALOMID will have the opportunity to add THALOMID to their dexamethasone regimen.
The thalidomide phase III special protocol assessment trial included patients with previously untreated (first-line) multiple myeloma. Patients were randomized to receive thalidomide plus dexamethasone or placebo plus dexamethasone alone. A total of 270 patients were randomized to receive thalidomide plus dexamethasone, or placebo plus dexamethasone, in this multi-centered clinical trial. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.
Patients treated with thalidomide and dexamethasone had an increase in side effects as compared to those patients only treated with placebo plus dexamethasone alone. These adverse drug events included insomnia, tremors, dizziness, peripheral neuropathy and constipation. Grade 3 or 4 adverse events reported included deep vein thrombosis (DVT) occurred in 10.3% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone, and pulmonary embolism (PE) occurred in 5.6% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone.
Safety Notice
THALOMID(R) (thalidomide) Capsules 50 mg, 100 mg, & 200 mg
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 who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the "System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Patients with neoplastic and various inflammatory conditions being treated with thalidomide in combination with other agents may have an increased incidence of thromboembolic events such as pulmonary embolism, deep vein thrombophlebitis, thrombophlebitis, or thrombosis. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide. Patients should be instructed to not extensively handle or open thalidomide capsules and to maintain storage of capsules in blister packs until ingestion.
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.
SOURCE: Celgene Corporation website www.celgene.com
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