The IDMC ( Independent Data Monitoring Committee ) found a statistically significant improvement in time to disease progression in patients with multiple myeloma receiving Lenalidomide ( Revlimid ) plus Dexamethasone compared to patients receiving Dexamethasone alone.
The Revlimid Phase III trials included patients with relapsed or refractory multiple myeloma.
Patients were randomized to receive Lenalidomide ( 25 mg/die ) plus Dexamethasone or Dexamethasone alone.
The trials enrolled 705 patients.
The primary endpoint was time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.
Lenalidomide belongs to a new class of immunomodulatory drugs, or IMiDs.
Ongoing studies are evaluating treatments with Lenalidomide for a broad range of hematology and oncology conditions, including multiple myeloma, myelodysplastic syndromes (MDS) as well as solid tumor cancers.
In clinical trials IMiDs appear to have an improved safety profile over thalidomide.
Sleepiness, constipation, or neuropathy, common side effects seen with Thalidomide therapy, are much less frequent.
At higher doses, toxicities seen included reduced blood cell ( platelet and neutrophil ) counts and skin rash.
Source: Celgene, 2005