Potentially good news for smoldering multiple myeloma patients from yesterday’s poster sessions here at ASH:
PHASE III STUDY EVALUATING REVLIMID® IN PATIENTS WITH HIGH-RISK SMOLDERING MULTIPLE MYELOMA REPORTED STATISTICALLY SIGNIFICANT REDUCTION IN RISK OF DISEASE PROGRESSION
Study Showed Overall Response Rate of 91% for Patients Who Completed Initial 9 Treatment Cycles
BOUDRY, SWITZERLAND – (December 4, 2010) – Celgene International Sàrl(NASDAQ: CELG) announced that data evaluating combination therapy REVLIMID® (lenalidomide) and dexamethasone in patients with high-risk asymptomatic smoldering multiple myeloma were presented during the American Society of Hematology’s annual meeting. The study reported REVLIMID and dexamethasone prolonged time to progression.
The Phase III, randomised, multicenter, open-label study evaluated whether early treatment with REVLIMID and dexamethasone in high-risk asymptomatic smoldering multiple myeloma patients prolonged time to progression to symptomatic disease compared to patients that did not receive treatment and were just observed.
Patients were treated with REVLIMID (25mg daily on days 1-21 of 28-day cycle) and dexamethasone (20mg on days 1-4, 12-15 of 28-day cycle) for nine four-week cycles and then continued treatment with a lower dose of REVLIMID (10mg daily on days 1-21 of 28-day cycle) until progression. The results showed an overall response rate of 75% (43/57), including 51% (29/57) PR, 12% (7/57) VGPR, 5% (3/57) CR and 7% (4/57) stringent CR (sCR). For the patients who completed the initial nine treatment cycles, the overall response rate was 91% (30/33), including 15% (5/33) VGPR, 9% (3/33) CR and 9% (3/33) sCR. For patients who then went on to receive continuous lenalidomide treatment, the sCR rate increased to 16% (5/32).
After a median follow-up of 16 months, disease progression was observed in 3% (4/118) of patients treated with REVLIMID and dexamethasone, while 18% (21/118) of patients progressed to active myeloma in the observation arm. 10 out of these 21 patients also developed bone lesions due to active myeloma.
The median time to symptomatic myeloma was 25 months in patients in the observation arm and has not yet been reached for patients who received REVLIMID and dexamethasone. (P<0.0001).
No Grade 4 adverse events were reported. Grade 3 adverse events included asthenia (7% 4/57), diarrhea (4% 2/57), infection (4% 2/57), anemia (2% 1/57) and skin rash (2% 1/57). 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.
I have such mixed feelings about this. Some would argue: Why not slow down or delay meyeloma’s onset for as long as possible? Others (including me) are concerned about the health and cost implications of starting chemotherapy so soon.
Either way, it is always good to have options. Feel good and keep smiling! Pat