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Velcade® Approved as Initial Therapy for Multiple Myeloma

Millennium Pharmaceuticals, The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited have received an additional approval by the United States Food and Drug Administration (FDA) for their agent Velcade® (bortezomib) as initial therapy for multiple myeloma. Velcade is also approved for the treatment of multiple myeloma and mantle cell lymphoma among patients who have received prior therapies.

Velcade is a proteosome inhibitor that has demonstrated a significant improvement in response rates when added to chemotherapy for the treatment of newly diagnosed multiple myeloma, as well as an improvement in survival when used in the treatment regimen of patients with multiple myeloma.

Velcade is a newer type of therapy known as proteasome inhibitor. It works by disrupting cellular processes and causing death of cancer cells. It is currently approved for the treatment of multiple myeloma in patients who have received prior therapy.

The added indication for Velcade includes both transplant-eligible and ineligible patients, and does not specify a chemotherapy regimen with which Velcade is to be used.

The addition of the proteasome inhibitor Velcade® (bortezomib) to the treatment combination Revlimid® (lenalidomide) plus dexamethasone improves survival when used as initial therapy in multiple myeloma among patients who do not intend to immediately undergo a stem cell transplant according to clinical trial results published in The Lancet.

A common standard treatment combination for newly diagnosed multiple myeloma includes Revlimid® and dexamethasone. Researchers continue to explore potential new combinations of therapies that improve outcomes for this group of patients.

Normal cellular processes include the breakdown of proteins that are no longer being used. The components of the protein that are broken down are then recycled into new, usable proteins. Proteasomes, structures found in healthy cells, play an important role in the breakdown and recycling of proteins.

Velcade® is a proteasome inhibitor, meaning it prevents proteasomes from breaking down unusable proteins in a cell. These proteins then start to accumulate within the cell, ultimately causing cellular death.

Researchers recently conducted a clinical trial to evaluate the effectiveness of Velcade in newly diagnosed multiple myeloma. The trial included 525 patients from 48 institutions: one group was treated with the addition of Velcade to Revlimid/dexamethasone, and the other group was treated with Revlimid/dexamethasone only, and results were directly compared. The patients in this trial had no intention of undergoing a subsequent stem cell transplant.

Researchers enrolled 471 eligible adult patients between February 2008 and February 2012 at 139 institutions throughout the National Cancer Trials Network. Patients ranged in age from 28 to 87, had active myeloma, and had not had a stem-cell transplant or any prior treatment for their disease. Patients were treated with a standard two-drug treatment consisting of Revlimid and dexamethasone for six cycles over six months or Revlimid, dexamethasone, and Velcade for eight cycles over six months and directly compared.

Patients receiving Velcade along with Revlimid and dexamethasone, in their first six months of treatment had a median remission time of 43 months compared to a median remission of 30 months for patients who received Revlimid and dexamethasone alone. Researchers also found that patients who received Velcade lived a median of 75 months, or about six years, after their initial treatment. Patients who received the standard two-drug treatment lived a median of 64 months, or about five years, after initial treatment.

Despite the increased remission and longevity, the three-drug combination did have a drawback: Patients who received Velcade were much more likely to experience sensory neuropathy, or tingling, pain, numbness or weakness in their hands and feet.


Durie, BGM, Hoering, A, Abidi, MH et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet. 2016; (published online Dec 22.)](

Velcade Improves Survival with Multiple Myeloma

Final results from the VISTA trial demonstrate that the addition of Velcade® (bortezomib) to melphalan and prednisone substantially improves overall survival among patients with previously untreated multiple myeloma. These results were presented at the 53rd Annual Meeting of the American Society of Hematology.

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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, which 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).

Velcade is the first in a new class of anticancer agents known as proteasome inhibitors. It’s been shown to provide benefits in the treatment of multiple myeloma and mantle cell lymphoma.

The VISTA study is an international Phase III clinical trial. The study involved 655 previously untreated multiple myeloma patients who were ineligible for stem cell transplantation. Patients were assigned to receive treatment with melphalan and prednisone alone (MP) or in combination with Velcade (VMP). Patients have now been followed for five years.

  • The addition of Velcade improved overall survival by more than 13 months: overall survival was 56.4 months among patients treated with VMP and 43.1 months among patients treated with MP.
  • Neither treatment group had an increased risk of second cancers compared with the general population.

These results suggest that the addition of Velcade to melphalan and prednisone improves overall survival among patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation.

Reference: San Miguel JF, Schlag R, Khuageva NK et al. Continued overall survival benefit after 5 years’ follow-up with bortezomib-melphalan-prednisone (VMP) versus melphalan-prednisone (MP) in patients with previously untreated multiple myeloma, and no increased risk of second primary malignancies: final results of the phase 3 VISTA trial. Presented at the 53rd ASH Annual Meeting and Exposition. San Diego, CA, December 10-13, 2011. Abstract 476.​

The pivotal clinical trial demonstrating Velcade’s effectiveness in the treatment of multiple myeloma is referred to as the SUMMIT trial. Although earlier data from this trial had been published previously, final and updated results from this trial have recently been published. This trial included 193 patients with multiple myeloma that had stopped responding to standard therapies. All patients were treated with Velcade.

The following results include follow-up of all patients for a median of 23 months:

  • 35% of patients achieved a complete or partial disappearance of their cancer (responders).
  • For responding patients, the median time to cancer progression was nearly 14 months; conversely, patients who did not achieve a response to Velcade had a median time to cancer progression of only 1.3 months.
  • For responding patients, the median duration of overall survival has not yet been reached (at 23 months); conversely, patients who did not achieve a response to Velcade had a median duration of survival of only 8 months.

The researchers concluded that long-term follow-up continues to confirm the effectiveness of Velcade in the treatment of recurrent multiple myeloma. Patients who respond to Velcade can achieve long-term survival with minimal side effects.

Patients with relapsed multiple myeloma whose disease has stopped responding to standard therapies may wish to speak with their physician regarding their individual risks and benefits of treatment with Velcade.

Reference: Richardson P, Barlogie B, Berenson J, et al. Extended Follow-Up of a Phase II Trial in Relapsed, Refractory Multiple Myeloma. Cancer. 2006; 106: 1316-1319.

Treanda/Velcade/Dexamethasone Produces High Response Rate in Relapsed/Refractory Multiple Myeloma

The combination of Treanda® (bendamustine), Velcade® (bortezomib) and dexamethasone produced a high response rate in patients with relapsed/refractory multiple myeloma, according to the results of a phase II study published in Blood.

Ludwig H, Kasparu H, Leitgeb C, et al. Bendamustine-bortezomib-dexamethasone is an active and well tolerated regimen in patients with relapsed or refractory multiple myeloma. Blood. Published early online November 13, 2013. doi: 10.1182/blood-2013-08-521468