Articles tagged with: Aplidin
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Die Jahrestagung der amerikanischen Gesellschaft für Klinische Onkologie (ASCO) hat letzten Freitagmorgen begonnen und wird bis Dienstag, den 7. Juni, dauern.
Jeden Tag finden Vorträge über das multiple Myelom statt. Freitag wurden die meisten Vorträge mit neuen Forschungsergebnissen über das Myelom gehalten. Es gab neun Vorträge während einer einzelnen Nachmittagssitzung, die sich auf das multiple Myelom konzentrierten.
Außerdem gab es am Samstag, Sonntag und Montag Fortbildungssitzungen über das multiple Myelom. Darüber hinaus gab es am Sonntag eine Sitzung mit sogenannten late-braking abstracts (hochaktuellen Zusammenfassungen), die eine Präsentation über wichtige, neue Forschungsergebnisse über …
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This year’s American Society of Clinical Oncology (ASCO) annual meeting began the morning of last Friday, and the meeting will run through Tuesday.
Multiple myeloma-related presentations are taking place every day of the meeting. Friday, however, was the busiest day at the meeting in terms of oral presentations with new myeloma-related research. There were nine such presentations during a single afternoon session focused on multiple myeloma.
In addition, there were myeloma-related education session presentations on Saturday, yesterday, and today. There also was a late-breaking abstract session yesterday (Sunday) with one presentation that …
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Good morning, myeloma world.
We all should have seen this coming.
After days and days of having no major myeloma business news to cover here at Myeloma Morning, what happens? Suddenly, there's not just one new myeloma-related business development to discuss. And not just two. But a full three such news items to review.
So let's start with those developments, after which we'll take a quick look at a new research article and what's been going on in the Beacon's forum.
Initial Results Of Darzalex MMY3004 Clinical Trial
We …
Press Releases»
PharmaMar intends to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year
Madrid (Press Release) – PharmaMar (MSE:PHM) today announced positive top-line results of its Phase III clinical trial -ADMYRE- with Aplidin® (plitidepsin) in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM). Aplidin® has shown a statistically significant 35% reduction in the risk of progression or death over the comparator (p=0.0054). The study has met its primary endpoint.
This pivotal, randomized, open-label, international, multicenter Phase III clinical trial, called ADMYRE, enrolled 255 patients in 83 medical …
Press Releases»
The pivotal study will assess the efficacy of plitidepsin plus dexamethasone versus dexamethasone alone in patients with relapsed / refractory multiple myeloma
Madrid (Press Release) – PharmaMar announced today that the patient recruitment for the pivotal Phase III trial of APLIDIN® (plitidepsin) for the treatment of multiple myeloma, denominated ADMYRE, has been successfully completed. The study, which originally planned to include 250 patients, has enrolled 255 patients in 71 medical centers worldwide, including the US, Europe, Asia, South America, Australia, and New Zealand. An application for marketing authorization in Europe is planned to be submitted in 2016.
ADMYRE …
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A Phase 2 clinical trial showed that plitidepsin alone had limited efficacy in heavily pretreated relapsed and refractory multiple myeloma patients. However, plitidepsin in combination with dexamethasone was effective enough to warrant further study. Plitidepsin alone or in combination with dexamethasone was well tolerated.
“Plitidepsin has not shown very significant efficacy when used in monotherapy,” explained Dr. María Mateos, the lead investigator of this study. “Nevertheless, in the present study we have seen some hints of activity in very heavily pretreated patients.”
Among the patients who received plitidepsin alone, 13 percent achieved …
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Myeloma Expert Dr. James R. Berenson To Field Questions At The Beacon Forums Next Week –Multiple myeloma patients will once again have the opportunity to get expert answers to their myeloma-related questions: Leading myeloma expert Dr. James R. Berenson, founder of the Institute for Myeloma & Bone Cancer Research, will answer medical questions posted to the Beacon’s multiple myeloma forums during the upcoming week. Readers are encouraged to begin posting their questions in the forums.
Potential Myeloma Treatment Mapatumumab Fails In Phase 2 Trials – Human Genome Sciences announced on Wednesday that results from a recent Phase 2 trial showed that mapatumumab (HGS-ETR1) in combination with Velcade (bortezomib) did not lead to better response rates or progression-free survival than Velcade alone. However, the treatment was well tolerated in trial participants. For more information, please see the Human Genome Sciences press release.
PharmaMar Initiates Phase 3 Myeloma Trial Of Plitidepsin – Spanish company PharmaMar on Tuesday announced the start of enrollment for an international Phase 3 trial of plitidepsin (proposed brand name: Aplidin) in relapsed/refractory multiple myeloma patients. The trial will enroll 300 patients and will test plitidepsin in combination with dexamethasone (Decadron) vs. dexamethasone alone. Plitidepsin is an antitumor agent of marine origin that is synthetically produced. For more information, please see the PharmaMar press release and the trial information at ClinicalTrials.gov.