The combination of Revlimid (lenalidomide) and dexamethasone for the treatment of relapsed or refractory multiple myeloma showed similar benefits in routine clinical practice as it did in the clinical trials that led to its approval, new research shows.
The study, “Lenalidomide plus dexamethasone for patients with relapsed or refractory multiple myeloma: Final results of a non-interventional study and comparison with the pivotal phase 3 clinical trials,” was published in the journal Leukemia Research.
The Phase 3 clinical trials MM-009 and MM-010, which included 704 patients with relapsed or refractory multiple myeloma, demonstrated that Revlimid plus dexamethasone was better as a treatment combo than a placebo and dexamethasone.
A long-term analysis of both trials revealed that more patients responded to the combination than to dexamethasone alone (60.6% vs. 21.9%), and that it had a better complete response rate (15% vs 2%). The combination treatment also significantly delayed disease progression or death from 4.6 months to 13.4 months, and extended patients’ lives from 31.6 months to 38 months.
These findings led to Revlimid’s approval in combination with dexamethasone as a second-line therapy for patients who had received one prior line of therapy. However, the benefits of the combination in a real-world setting previously were unknown.
So, researchers at the Agaplesion Bethanien Hospital in Germany studied the benefits of Revlimid plus dexamethasone in 98 patients treated in routine clinical practices.
Patients in the study had a median age of 71, which was higher than the median ages of the pivotal Phase 3 studies (64 and 63, respectively). Among the patients studied, 47 received the combination as a second-line therapy, and 51 received it as a third-line or higher therapy.
Of the 98 patients, 60.2 percent responded to the therapy, with median overall survival at about 24.3 months.
Median survival, however, was longer in patients who had received only one prior therapy, at about 35.5 months. For those who had already received two or more prior therapies, the median overall survival was 21.1 months.
The treatment was discontinued in cases of tumor progression (37.8%), tumor remission (12.2%), toxicity (12.2%), or death (12.2%).
Common adverse events were anemia, low blood platelets, and low white blood cell counts. The results are comparable to those of the MM-009 and MM-010 Phase 3 clinical trials, researchers said.
Disease progression was observed in 34 percent of patients. The high rate of progressive disease seen in the study “may be linked to the advanced age that was higher than in the patient population in the registration trials,” researchers said.
A total of 61 patients received preventive treatment for thrombosis. However, seven experienced thromboembolic events (the formation of a clot in a blood vessel that breaks loose and is carried by the bloodstream to block another vessel).
Researchers recommended that preventive treatment for thrombosis should be required for all multiple myeloma patients receiving Revlimid plus high-dose dexamethasone. They also said biomarkers are needed for increased blood clotting to identify patients most likely to benefit from preventive thrombosis treatment.