Celgene announces data from REVLIMID Phase III study on high-risk asymptomatic smoldering MM

Dec 14 2011

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced that updated data evaluating continuous treatment with REVLIMID^® (lenalidomide) in patients with high-risk asymptomatic smoldering multiple myeloma were presented at the 53^rd Annual Meeting of the American Society of Hematology. The study demonstrated that early treatment with lenalidomide and dexamethasone followed by continuous lenalidomide delayed time to symptomatic disease and demonstrated a projected survival advantage compared with observation.

The Phase III, randomized, multicenter, open-label study evaluated whether continuous treatment with lenalidomide in high-risk asymptomatic smoldering multiple myeloma patients prolonged time to progression to symptomatic disease compared with patients who did not receive treatment and were just observed, which is the current standard of care for smoldering multiple myeloma.

Of 119 evaluable patients, 57 were treated with lenalidomide (25 mg daily on days 1-21 of a 28-day cycle) and dexamethasone (20 mg on days 1-4 and 12-15 of a 28-day cycle) for nine four-week cycles and then continued treatment with a lower dose of lenalidomide (10 mg daily on days 1-21 of a 28-day cycle) until disease progression, while there were 62 patients in the therapeutic abstention arm.

After a median follow-up of 22 months, 9 of 57 (15%) patients progressed to symptomatic disease in the treatment arm. In addition, 14 patients developed biological progression during maintenance, and dexamethasone was added according to protocol, with 10 of these patients subsequently achieving disease control. In the no treatment arm, 37 of 61 patients (59%) progressed to active MM. The median time to progression (TTP) from inclusion was 23 months for the delayed treatment arm, while the median TTP has not been reached in the treatment arm (p<0.0001) (HR 6.0; 95%).

No Grade 4 adverse events were reported. Grade 3 adverse events during induction included asthenia (7%, 4/57), diarrhea (4%, 2/57), infection (2%, 1/57), anemia (2%, 1/57) and skin rash (2%, 1/57).

Three patients in the treatment arm developed second primary malignancies (SPM). One developed polycythemia vera JAK2+ during treatment, but an analysis of a frozen DNA sample obtained at the time of screening showed that the patient was already JAK2+ at enrollment. The second two SPMs were prostate cancer in patients with previous history of prostate enlargement plus elevated prostate specific antigen (PSA).

These data are from an investigational study. REVLIMID is not approved as a treatment for high-risk smoldering multiple myeloma.

Source: Celgene International Sàrl