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IMW 2009 - Elotuzumab And Panobinostat Clinical Trials With Velcade

By: Amrita Purohit; Published: April 9, 2009 @ 10:45 am | Comments Disabled

At the XII International Myeloma Workshop (IMW), physicians presented data on new clinical trials for multiple myeloma treatment. Results from separate Phase 1 trials indicate that elotuzumab and panobinostat enhance Velcade's [1] (bortezomib) efficacy in myeloma treatment.

Elotuzumab is an antibody that attaches to a cell surface protein called CS1, which is present in all myeloma cells but not in normal human cells. Dr. Jakubowiak, professor of hematology and oncology at the University of Michigan in Ann Arbor, conducted the Phase 1 trials.

In the study, patients were treated with Velcade and elotuzumab in three-week cycles. Velcade was administered on days one, four, eight, and 11; elotuzumab was given on days one and 11. All patients had not received anti-myeloma treatment for the previous two weeks.

A dose-escalating cohort study was also done. All four cohorts received the same 1.3 mg/kg Velcade dose but different doses of elotuzumab (2.5 mg/kg, 5 mg/kg, 10 mg/kg, and 20 mg/kg). Dexamethasone [2] was added if the patient’s condition worsened at the end of the second or third cycle. Patients who stabilized by the end of four cycles continued with the treatment.

Data reported for 13 patients showed that 9 patients continued with treatment after the fourth cycle and only two had dexamethasone added to their treatment.

Five serious side effects were reported with this study: infection, vomiting, pneumonia, chest pain, and diarrhea. The common adverse effects were diarrhea, fatigue, and nausea.

Dr. Orhan Sezer reported the results from the Phase 1b trials of panobinostat given to 22 patients with relapsed multiple myeloma. Panobinostat is a compound that suppresses cell growth, however the exact mechanism by which it does this is unknown. It is thought to interfere with protein expression in cancer.

Three cohort studies were done and efficacy data for 11 patients was reported. Of the 11 patients, three were complete responders, one had a very good partial response, and seven had partial responses.

One adverse effect was severely low white blood cell count; others included diarrhea, fatigue, and nausea.

According to Dr. Sezer, "Preliminary data from the ongoing Phase 1 trial suggest that oral panobinostat can be safely combined with [Velcade]."

Multiple myeloma patients who are interested in participating in clinical trials should discuss options with their doctor. Information on the elotuzumab and Velcade trial can be found at ClinicalTrials.gov. [3] Also, a Phase 1 clinical trial [4] testing Alkeran (melphalan) and panobinostat combination is recruiting patients.

For more information about elotuzumab and panobinostat, visit the Oncology Stat [5] Web site.


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URL to article: https://myelomabeacon.org/news/2009/04/09/imw-2009-elotuzumab-and-panobinostat-clinical-trials-with-velcade/

URLs in this post:

[1] Velcade's: https://myelomabeacon.org/resources/2008/10/15/velcade/

[2] Dexamethasone: https://myelomabeacon.org/resources/2008/10/15/dexamethasone/

[3] ClinicalTrials.gov.: http://clinicaltrials.gov/ct2/show/NCT00726869?term=Elotuzumab&rank=1

[4] clinical trial: http://clinicaltrials.gov/ct2/show/NCT00743288?term=Panobinostat+AND+multiple+myeloma&rank=1 to

[5] Oncology Stat: http://www.oncologystat.com/news-and-viewpoints/news/Elotuzumab_And_Panobinostat_May_Enhance_Bortezomib.html

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