Study data of REVLIMID-dexamethasone combination therapy for high-risk smoldering multiple myeloma

Dec 8 2009

Celgene International Sàrl (NASDAQ:CELG) announced that data evaluating combination therapy REVLIMID (lenalidomide) and dexamethasone in patients with high-risk smoldering multiple myeloma were presented during the American Society of Hematology’s annual meeting in New Orleans, LA. The landmark study demonstrated REVLIMID and dexamethasone prolonged time to progression, including complete responses, with manageable toxicity.

The multicentre, randomised, open-label study evaluated whether early treatment with REVLIMID and dexamethasone prolongs time to progression compared to the observation arm without treatment of high-risk smoldering multiple myeloma patients.

Patients were treated with REVLIMID and dexamethasone for nine four-week cycles and then continued treatment with a lower dose of REVLIMID to sustain disease control until progression. The results showed an overall response rate of 81%, including 30% with a very good partial response or better. For the patients who completed the initial nine treatment cycles, the overall response rate was 91%.

After a median follow-up of 14 months, disease progression was observed in two patients (4%) treated with REVLIMID and dexamethasone, while sixteen (34%) patients progressed to active myeloma in the arm with no treatment. Ten out of 16 of those patients also developed bone lesions due to active myeloma. It was noted that the two patients who progressed after receiving REVLIMID^® and dexamethasone progressed only after stopping therapy with REVLIMID.

The median time to symptomatic myeloma was 19.3 months in patients who did not receive treatment and is not yet reached for patients who received REVLIMID and dexamethasone. (P<0.0001). Two patients have died on the study, both of these patients did not receive REVLIMID or dexamethasone.

No Grade 4 adverse events were reported. Grade 3 adverse events included constipation (9%), asthenia (4%), with other individual grade 3 events no more common than 2%. One patient discontinued treatment because of adverse events. Dose adjustments were made as necessary to manage toxicity.

REVLIMID is not approved as a treatment for high-risk smoldering multiple myeloma.