Relapsed/Refractory Patients:

Treanda^® (bendamustine)

What is Treanda?

Treanda (bendamustine) is an intravenous chemotherapy agent. It is an alkylating agent that is thought to kill tumor cells by damaging their DNA, but is also similar in structure to another class of cancer drugs and may have other anti-tumor effects.

Bendamustine is approved for the treatment of myeloma in Germany under the name Ribomustin^® and has been used there for many years. Treanda is currently FDA-approved for the treatment of two other cancers, chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin lymphoma. Treanda is made by Cephalon Oncology.

What do we know about Treanda's activity in myeloma?

Much of what we know about bendamustine's activity in myeloma is from research and studies conducted in Europe. In the laboratory, bendamustine appears to be active against myeloma cells that are resistant to other alkylating agents. Benadmustine has been evaluated and used alone and in combination with other anti-myeloma agents.

For example, the combination of bendamustine and prednisone was found to be more effective than the standard combination melphalan and prednisone (MP) in patients with newly diagnosed myeloma in a phase III study conducted in Germany in 2005 (n=131). Bendamustine-prednisone therapy resulted in a higher overall response rate, a significantly higher complete response rate (32% vs. 13% with MP), and a longer time to disease progression.

Bendamustine has been used in Europe in the relapsed/refractory setting in a number of ways, including:

• As a single agent
• In combination with a corticosteroid (prednisolone) and Thalomid^® (thalidomide)
• As an 'add-on' therapy when patients had not responded to the combination of Velcade^® (bortezomib) and dexamethasone

Recent trials have demonstrated the safety and efficacy of various bendamustine combinations in the relapsed and/or refractory setting. For example:

• Bendamustine, Revlimid® (lenalidomide), and dexamethasone was shown to be is safe and highly effective in patients with relapsed or refractory myeloma in a Phase I trial. The authors note that the side effect profile of this combination makes it an attractive option for patients with pre-existing therapy-related peripheral neuropathy.
• Bendamustine and a reduced dose of Velcade was shown to be safe and effective in heavily-pretreated relapsed/refractory myeloma in the Phase I portion of a Phase I/II study. The Phase II portion of the study is ongoing.

In addition, the combination of bendamustine, Thalomid, and dexamethasone has been shown to be a useful regimen for extensively pre-treated patients with prior exposure to Velcade and Revlimid, [West IMW 2011 #P226] as well as an effective and well-tolerated therapy for myeloma patients with reduced kidney function.

How is Treanda currently being studied in myeloma?

Treanda is being studied as initial therapy for myeloma in several trials in the United States, including:

• A phase II trial in combination with Velcade and dexamethasone (BBD) in patients who are not candidates for high-dose chemotherapy and autologous stem cell transplant.
• A phase I trial in combination with melphalan in patients with myeloma who are undergoing an autologous stem cell transplant, which has completed enrollment.

Treanda is also being studied in a number of trials in relapsed and/or refractory myeloma, including:

• In combination with Revlimid and dexamethasone in patients with relapsed myeloma in a phase IB/II clinical trial that is being facilitated by the Multiple Myeloma Research Consortium (MMRC). LEARN MORE »
• In combination with Velcade in patients with relapsed/refractory myeloma in a phase II trial.
• As part of a regimen that includes Zocor® (simvastatin), Zometa® (zoledronic acid), Velcade, Treanda, and methylprednisolone, which is being evaluated in a phase II trial.
• In combination with Velcade and Doxil® (pegylated liposomal doxorubicin) in a Phase I/II trial in patients with relapsed or refractory myeloma.
• In a Phase I/II trial in combination with carfilzomib (Celgene) as a replacement for Velcade in patients who are relapsed/refractory to Velcade-containing treatments

To find a clinical trial, call 1-866-603-MMCT (-6628) or click here to go to the MMRF Patient Navigator Program.