Among patients with newly diagnosed multiple myeloma (MM) who are ineligible for high-dose therapy and stem cell transplant, treatment with a combination of Velcade® (bortezomib), melphalan, prednisone, and thalidomide followed by maintenance therapy with Velcade and thalidomide (VMPT-VT) resulted in better response rate and progression-free survival than treatment with Velcade, melphalan, and prednisone (VMP) without maintenance therapy. These findings were recently 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, which causes the breakdown of bone. 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. These abnormal antibodies are referred to as paraproteins or monoclonal proteins in the blood (M proteins) or urine (Bence Jones protein).
For patients older than 65 who may be ineligible for high-dose therapy and stem cell transplant, treatment of multiple myeloma often involves VMP or melphalan-prednisone-thalidomide.
To evaluate the addition of a fourth drug to VMP, along with maintenance therapy, researchers in Italy conducted a Phase III clinical trial among more than 500 patients with newly diagnosed multiple myeloma. Maintenance therapy refers to treatment that is given after a cancer has responded to initial treatment.
Patients enrolled in this study were not candidates for high-dose therapy plus stem-cell transplantation due to either age or other health problems. Study participants were treated with VMPT followed by maintenance therapy with VT or VMP without maintenance therapy.
- Patients in the VMPT-VT arm experienced more frequent side effects, including neutropenia (low white blood cell counts), heart problems, and blood clots. Treatment-related deaths occurred in 4% of patients in the VMPT-VT group versus 3% in the VMP group.
- Three-year progression-free survival was 56% for patients in the VMPT-VT group and 41% in the VMP group.
- 38% of patients in the VMPT-VT group experienced a complete response compared with 24% in the VMP group.
- Three-year overall survival was 89% in the VMPT-VT group versus 87% in the VMP group. This difference in overall survival did not meet the criteria for statistical significance, suggesting that it could have occurred by chance alone.
The researchers concluded that newly diagnosed MM patients who were not candidates for high-dose therapy plus stem cell transplant experienced a progression-free survival and complete response benefit with VMPT-VT treatment compared with VMP. Individualizing treatment strategies for elderly patients and patients with other health problems is critical to optimizing health outcomes both in terms of survival and quality of life.
 Palumbo A, Bringhen S, Rossi D, et al. Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: A randomized controlled trial. Journal of Clinical Oncology [early online publication]. October 12, 2010.
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