Study Evaluating REVLIMID® Combination Compared to Autologous Stem Cell Transplant with or without REVLIMID …

BOUDRY, Switzerland--(BUSINESS WIRE)--

Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation (CELG), today announced data from a study comparing melphalan, prednisone and REVLIMID (lenalidomide) (MPR) with high-dose chemotherapy and tandem autologous stem cell transplant (MEL200), as well as evaluating the effect of lenalidomide maintenance in patients with newly-diagnosed multiple myeloma were presented during a June 3rd oral session at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in Chicago, Ill.

In the study, conducted by the Gruppo Italiano Malattie EMatologiche dellAdulto (GIMEMA), and presented by lead investigator, Prof. Antonio Palumbo, Chief of the Myeloma Unit, Department of Oncology, at the University of Torino, a total of 402 patients received four 28-day courses of lenalidomide and low-dose dexamethasone at diagnosis, and then were randomly assigned to receive six cycles of MPR (n=202) or MEL200 (n=200), and to receive either continuous lenalidomide maintenance treatment or to be followed by observation.

After a median follow-up of 49 months from diagnosis, median progression-free survival (PFS), the primary endpoint of the study, was 24 months with MPR compared to 38 months with MEL200 (HR 1.69, p

In the maintenance analysis, with a median follow-up of 35 months, patients receiving lenalidomide maintenance following either regimen, had a median PFS of 37 months compared to 26 months for observation (HR 0.52, p

The most common grade 3/4 adverse events observed during the maintenance phase of the study were neutropenia (23%), cutaneous toxicity (5%), infections (4%), second primary malignancies (4%), thrombocytopenia (4%), diarrhea (3%), fatigue (3%) and anemia (2%).

These results are from an investigational study. REVLIMID is not approved for the treatment of patients with newly-diagnosed multiple myeloma.

About REVLIMID

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy, in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.

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Study Evaluating REVLIMID® Combination Compared to Autologous Stem Cell Transplant with or without REVLIMID ...

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