Posted on March 8th, 2009 by
At the 2008 meeting of the American Society of Hematology (ASH) in December, there were several oral presentations on the outcomes of newly diagnosed patients with multiple myeloma where Revlimid® (lenalidomide) was incorporated into the induction or maintenance regimens.
Revlimid is an orally administered derivative of thalidomide, which is a very active agent for the treatment of refractory multiple myeloma. Revlimid is reported to have less toxicity than thalidomide, but retains significant anti-myeloma effects. Revlimid is currently being evaluated for the initial treatment of patients with multiple myeloma.
Revlimid and Dexamethasone for Induction
The most commonly studied Revlimid regimen for the initial treatment of patients with myeloma involves the addition of dexamethasone. Researchers involved in a multicenter trial reported that time to tumor progression and progression-free survival in patients receiving Revlimid and dexamethasone were worse in patients with adverse cytogenetics (higher risk features) compared with patients with standard risk features. Median progression-free survival was 18.5 months for 16 patients with adverse cytogenetics compared with 36.5 months for 84 patients with standard risk features. However, because of the success of salvage therapy, there were no differences in overall survival between the good and bad risk groups.
Revlimid, Cytoxan, and Dexamethasone for Induction
Researchers from the Mayo Clinic reported an overall response rate of 83% for 53 patients with newly diagnosed multiple myeloma with the combination of Revlimid, Cytoxan® (cyclophosphamide), and dexamethasone. The complete and very good partial remission rate was 40%. This regimen appeared to be well tolerated.
Relvimid, Velcade®, and Dexamethasone for Induction
Researchers affiliated with a multicenter U.S. clinical trial reported the results of a Phase I/II evaluation of induction with the combination of Revlimid, Velcade® (bortezomib), and dexamethasone in previously untreated patients with myeloma with high-risk features. There were 63 patients in this study, and 39 had abnormal cytogenetics. All patients in this study had a partial or greater response, and 66% had a very good partial response or complete response. Among patients with adverse cytogenetics, 79% had a very good partial response or better. Fifteen patients proceeded to transplantation following successful completion of stem cell collection. This regimen appears to be very active in producing remissions in patients prior to autologous stem cell transplantation.
Revlimid, Velcade, Cytoxan, and Dexamethasone for Induction
Researchers involved in a U.S. multicenter trial reported that the combination of Velcade, dexamethasone, Cytoxan, and Revlimid for initial treatment of patients with myeloma was well-tolerated and produced a high response rate. Preliminary data showed that 100% of patients achieved a partial response or better, with approximately 50% achieving a complete response. These authors suggest that this regimen is tolerable and highly active in newly diagnosed patients with myeloma.
Revlimid for Consolidation/Maintenance
Italian researchers presented the results of a study where Revlimid was administered as consolidation/maintenance therapy after reduced-intensity autologous stem cell transplants in elderly patients with newly diagnosed myeloma. This study included over 100 patients aged 65-75 years with newly diagnosed myeloma. All patients received induction therapy with Velcade, dexamethasone, and Adriamycin® (doxorubicin) followed by tandem autologous stem cell transplants with 100 mg/m2 of Alkeran® (melphalan). Peripheral blood stem cells were harvested after Cytoxan and Neupogen® (figrastim). Revlimid was given after recovery from tandem autologous transplants. After consolidation/maintenance with Revlimid, 88% of patients achieved at least a very good partial remission and 53% a complete remission. One-year survival was 92%.
 Kapoor P, Kumar S, Fonseca R, et al. Survival in patients with newly diagnosed myeloma undergoing therapy with lenalidomide and dexamethasone: Impact of high-risk cytogenetic risk status on outcome. Blood. 2008;112:42, abstract number 95.
 Kumar S, Hayman S, Buadi F, et al. Phase II trial of lenalidomide (Revlimid™) with cyclophosphamide and dexamethasone (RCd) for newly diagnosed myeloma. Blood. 2008;112:40, abstract number 91.
 Richardson P, Lonial S, Jakubowiak A, et al. Lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma: Encouraging efficacy in high risk groups with updated results of a phase I/II study. Blood. 2008;112:41, abstract number 92.
 Kumar S, Finn IW, Noga SJ, et al. Safety and efficacy of novel combination therapy with bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in newly diagnosed multiple myeloma: Initial results from the Phase I/II Multi-Center EVOLUTION Study. Blood. 2008;112:41, abstract number 93.
 Palumbo A, Falco P, Gay F, et al. Bortezomib-doxorubicin-dexamethasone as induction prior to reduced intensity autologous transplantation followed by lenalidomide as consolidation/maintenance in elderly patients. Blood. 2008;112:66, abstract number 159.
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