Researchers affiliated with the German Myeloma Study Group have reported that a regimen of Revlimid® (lenalidomide), Adriamycin® (doxorubicin), and dexamethasone supported by Neulasta® (pegfilgrastim) resulted in a 74% complete or very good partial remission rate in patients with relapsed and refractory multiple myeloma. The details of this study appeared in an early online publication in Blood of January 30, 2009.[1]

The development of new agents such as Revlimid, Thalomid® (thalidomide), and Velcade® (bortezomib) have had a major impact in treating relapsed and newly diagnosed patients with multiple myeloma. Researchers are still evaluating the optimal way to incorporate these new agents into the most effective treatment regimens. Revlimid has been incorporated into several combination regimens for treatment of newly diagnosed or relapsed myeloma with promising results.

The current Phase I-II study evaluated Revlimid, Adriamycin, dexamethasone, and Neulasta in 69 patients with myeloma who had failed intensive treatment. The median age of patients in this study was 65 years, with the oldest patient being 77 years old. In this study the maximum tolerated doses of Revlimid and Adriamycin given with Neulasta was not reached. The Phase II component of the study used a Revlimid dose of 25 mg on days 1-21 and Adrimycin 9 mg/m2 on days 1-4. The dexamethasone dose was 40 mg on days 1-4 and days 17-20. The main side effects were grade 3-4 neutropenia and thrombocytopenia seen in almost half of the patients. Thromboembolic events occurred in 4.5%, and severe infections in 10%. The overall response rate was 73% for the entire group and 77% for the highest dose level. Seventy-four percent had complete or very good partial remissions at the highest dose level. Patients with deletion of chromosome 17p and those with an elevated beta 2 microglobulina had worse outcomes than those without these features. These authors suggest that this regimen is very effective and has an “acceptable toxicity” profile.

Comments: This regimen can be added to the growing list of effective Revlimid-based combinations active for treating patients with multiple myeloma. This is also another example of Neulasta possibly allowing safe administration of a dose-intense regimen.

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