March 8, 2009

Velcade® Combinations for Newly Diagnosed Patients with Multiple Myeloma at ASH 2008


Velcade® Combinations for Newly Diagnosed Patients with Multiple Myeloma at ASH 2008

At the 2008 meeting of the American Society of Hematology (ASH) in December in San Francisco, there were several oral presentations on the outcomes of newly diagnosed patients with multiple myeloma where Velcade® (bortezomib) was incorporated into the induction regimen.

Velcade is the first in a new class of anticancer agents known as proteasome inhibitors that has been extensively evaluated in patients with relapsed myeloma. Recent studies have focused on Velcade combinations in induction regimens and preliminary data shows very high response rates.

Velcade, Adriamycin®, and Dexamethasone for Induction

Italian researchers presented the results of a study of induction therapy with Velcade, Adriamycin® (doxorubicin), and dexamethasone prior to planned reduced-intensity autologous stem cell transplants in elderly patients with newly diagnosed myeloma.[1] This study included over 100 patients aged 65-75 years with newly diagnosed myeloma. All received induction therapy with Velcade, dexamethasone, and Adriamycin followed by tandem autologous stem cell transplants with 100 mg/m2 of Alkeran® (melphalan). Peripheral blood stem cells were harvested after Cytoxan® (cyclophosphamide) and Neupogen® (filgrastim). Revlimid® (lenalidomide) was given after recovery from tandem autologous transplants. After induction therapy 94% of patients had at least a partial response. At least a very good partial response was observed in 59%, and 13% had a compete response. After tandem autologous transplants, 41% of patients had a complete remission, and after Revlimid consolidation/maintenance the complete remission rate was 53%. One-year survival was 92%. These authors concluded that Velcade, Adriamyicin, and dexamethasone was a very effective induction regimen that allowed the collection of autologous stem cells.

Velcade, Cytoxan, Revlimid, 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.[2] 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.

Velcade/Alkeran/Prednisone Versus Velcade/Thalomid®/Prednisone for Induction

Researchers from Spain compared a regimen of Velcade, Alkeran, and prednisone (VMP) versus Velcade, Thalomid® (thalidomide), and prednisone (VTB) for induction therapy in elderly newly diagnosed patients with myeloma.[3] This is a large randomized trial that will ultimately enroll 260 patients. The following table summarizes the main findings of this trial.

Table 1: VMP Versus VTB in Newly Diagnosed Myeloma



Number of Patients



Partial Response or Better



Complete Response



>Grade 2 Neutropenia



>Grade 2 Cardiotoxicity






> Grade 2 Neurotoxicity



Treatment Discontinued

8 Patients

16 Patients

These authors suggest that VMP may be superior to VTB due to the increased rate of therapy discontinuations. The final results of this study will be of major interest.

Velcade, Revlimid, 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, and dexamethasone for the treatment of previously untreated patients with myeloma with high risk factors.[4] There were 63 patients in this study, and 24 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 cells. This regimen appears to be very active in producing remissions in patients prior to autologous stem cell transplantation.


[1] 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.

[2] 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.

[3] Mateos M-V, Oriol A, Martinez, et al. Bortezomib (Velcade)-melphalan-prednisone (VMP) versus Velcade-thalidomide-prednsone (VTP) in elderly untreated multiple myeloma patients: Which is the best partner for Velcade: An alkylating or an immunomodulator agent? Blood. 2008;112:243, abstract number 651.

[4] 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.

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