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Phase 2 Trial Results of Lenalidomide Reported at Hematology Meeting
At ASH, during an oral presentation, lead investigator Vincent Rajkumar, M.D., Associate Professor of Medicine at Mayo Clinic presented the preliminary results of the Phase II trial using the combination of REVLIMID plus dexamethasone with aspirin as initial therapy for newly diagnosed MM. The median age was 64 years (range, 32-78). Thirty-one of 34 patients achieved an objective response of 91% defined as at least 50% reduction in the level of the serum monoclonal (M) protein and a reduction in 24-hour urinary M protein level of at least 90% or to less than 200mg. Two patients (6%) achieved a complete response (CR) and eleven patients (32%) achieved a near complete response (nCR). Eighteen patients (53%) achieved a partial response (PR). Response rates were rapid with the median time to response of 1 month. Adequate stem cells were collected in all patients who proceeded to stem cell transplantation. Fifty-three percent of patients experienced grade 3 or higher non-hematolgoic toxicity, most commonly; fatigue (18%), muscle weakness (6%), anxiety (6%), pneumonitis (6%) and rash (6%). One patient died on study and this was attributed to infection unrelated to therapy. One patient developed a pulmonary embolism, but recovered with therapy.
"These Phase II results support additional evaluation of the combination of REVLIMID and dexamethasone in newly diagnosed MM, such as the large randomized controlled Phase III trial using REVLIMID and dexamethasone that has recently started and is being conducted by the Eastern Cooperative Oncology Group," explained Dr. Rajkumar.
About the Trial:
The Phase II trial was designed to accrue 34 eligible patients. Patients were enrolled between February 2004 and July 2004. REVLIMID was given orally at a dose of 25 mg daily on days 1-21 of a 28-day cycle. Dexamethasone was given orally at a dose of 40 mg daily on days 1-4, 9-12, 17-20 of each cycle. Patients also received an aspirin once daily as thrombosis prophylaxis. Response was defined as a decrease in serum monoclonal (M) protein by 50% or higher and a decrease in urine M protein by at least 90% or to a level less than 200 mg/24 hours, and needed to be confirmed by two readings at least 4 weeks apart. Responses were assessed on an intent-to-treat basis.
REVLIMID is a member of a group of proprietary novel compounds, IMiDs(R), that are being evaluated by Celgene as a treatment for a broad range of hematology and oncology conditions, including; multiple myeloma, myelodysplastic syndromes (MDS), chronic lymphocytic leukemia as well as solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of-matter and use patents.
REVLIMID(R) is not approved by the FDA or any other regulatory agencies as a treatment for any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immuno-globulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.
Source: Celgene Corporation