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

June 12, 2017

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 S? rl