Articles tagged with: Clinical Trial Results

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[ by | Aug 1, 2013 7:30 am | Comments Off ]
Study Of Revlimid (Lenalidomide) In Patients With High-Risk Asymptomatic Smoldering Multiple Myeloma Published In New England Journal of Medicine

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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[ by | Jul 11, 2013 7:30 am | Comments Off ]

Statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free survival dem­onstrated

Phase III Study (MM-020/IFM 07-01) of Oral Revlimid (Lenalidomide) in Newly-Diagnosed Multiple Myeloma Meets Primary Endpoint 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 …

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[ by | Jun 15, 2013 11:45 am | Comments Off ]
  • Median progression-free survival (PFS) of 33 months reached after longer-term follow up in patients treated with elotuzumab 10 mg/kg plus lenalidomide and low-dose dexamethasone
  • Longer-term safety profile of the combination consistent with previously reported results
  • Results Presented at 18th Annual Congress of the European Hematology Association
  • Two Phase 3 studies of elotuzumab at 10 mg/kg dose ongoing in patients with previously-treated and newly-diagnosed multiple myeloma

Bristol-Myers Squibb And AbbVie Announce Progression-Free Survival Data From Phase 2 Open-Label Study Of Investigational Agent Elotuzumab In Combination With Lenalidimide And Dexa­metha­sone In Previously-Treated Multiple Myeloma Princeton, NJ and North Chicago, IL (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) and AbbVie (NYSE: ABBV) to­day an­nounced up­dated ef­fi­cacy and safety data from a small, ran­dom­ized Phase 2, open-label study in patients with pre­vi­ously-treated mul­ti­ple myeloma that eval­u­ated two doses of the inves­ti­ga­tional mono­clonal anti­body elotuzumab (10 mg/kg and 20 mg/kg) in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone. In the 10 mg/kg arm (N=36), which is the dose used in the on­go­ing Phase 3 trials, median pro­gres­sion-free sur­vival (PFS), or the time without dis­ease pro­gres­sion, …

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