In a Phase II clinical trial, treatment of older multiple myeloma patients with Velcade® (bortezomib) induction therapy, reduced-intensity tandem autologous stem cell transplantation, and Revlimid® (lenalidomide) consolidation-maintenance therapy produced promising response rates. These results were published in the Journal of Clinical Oncology.
Multiple myeloma is a cancer of plasma cells. Plasma cells are a special type of white blood cell that are part of the body’s immune system. Plasma cells normally live in the bone marrow and make proteins, called antibodies, that circulate in the blood and help fight certain types of infections. Plasma cells also play a role in the maintenance of bone, by secretion of a hormone called osteoclast-activating factor. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.
Over the past two decades, there has been marked improvement in overall survival of patients with multiple myeloma. This improvement in survival has been due to the adoption of single or tandem, melphalan-based autologous stem cell transplants in younger, more fit patients, as well as the development of new drugs such as Thalomid® (thalidomide), Revlimid, and Velcade. These new drugs have improved outcomes of patients not suitable for stem cell transplantation and are now beginning to have an impact on transplant patients as well.
The current study involved 102 newly diagnosed multiple myeloma patients between the ages of 65 and 75. Induction therapy was a combination of Velcade, Doxil® (liposomal doxorubicin), and dexamethasone. All patients were scheduled to receive tandem, reduced-intensity, autologous stem cell transplants. The dose of melphalan was reduced from the standard 200 mg/m2 to 100 mg/m2. Four cycles of Revlimid were given for consolidation followed by Revlimid maintenance.
- After induction therapy 58% of patients had a very good partial response (VGPR) or better, with a 13% complete response (CR) rate.
- After transplantation, 82% had a VGPR or better, with a CR rate of 38%.
- After Revlimid maintenance, 86% had a VGPR or better, with a CR rate of 66%.
- Two-year progression-free survival was 69%.
- Two-year overall survival was 86%.
This study shows that tandem autologous transplants can be administered to myeloma patients between the ages of 65 and 75 years. The addition of Revlimid and Velcade also appears to improve outcomes in this group of patients. The researchers recommend further testing of this treatment approach in Phase III clinical trials.
Reference: Palumbo A, Gay F, Falco P, et al. Bortezomib as induction before autologous transplantation, followed by lenalidomide as consolidation-maintenance in untreated multiple myeloma. Journal of Clinical Oncology [early online publication]. January 4, 2010.
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