The results of a recent French analysis indicate that the cancer drug Treanda, in combination with prednisone or dexamethasone, may be effective in relapsed and refractory multiple myeloma patients.

Based on their findings, the French researchers recommended that Treanda ^[1] (bendamustine) be considered as a treatment option for patients with advanced multiple myeloma.

Treanda is an alkylating agent, which causes cancer cell death by damaging the cancer cells’ DNA.  The drug, which was originally developed in East Germany in the 1960s, is currently approved by the FDA to treat certain types of leukemia and lymphoma.

Treanda also is approved in a number of European countries to treat multiple myeloma in patients older than 65 years who are not eligible for stem-cell transplantation and cannot be treated with thalidomide ^[2] (Thalomid) or Velcade ^[3] (bortezomib).

Cephalon Inc., the company that markets Treanda in the United States, is currently sponsoring several Phase 1 and Phase 2 clinical trials that are investigating Treanda as a multiple myeloma treatment.   In a recent Phase 1 trial, Treanda showed promising activity in combination with Revlimid ^[4] (lenalidomide) and dexamethasone ^[5] (Decadron) (see related Beacon ^[6] news).

In 2007, French health authorities allowed Treanda to be used for the treatment of refractory/relapsed multiple myeloma under a compassionate use program. The program allows physicians to prescribe non-approved drugs for the treatment of patients with serious or life-threatening illnesses when all approved therapies have failed.

In the current study, the French researchers retrospectively analyzed data from 110 relapsed/refractory multiple myeloma patients who received Treanda under the compassionate use program between 2007 and 2009. The median patient age was 63 years.

In order to receive Treanda under the compassionate use program, patients had to be refractory (resistant) to prior treatment with all classes of approved multiple myeloma drugs, including alkylating agents, such as cyclophosphamide ^[7] (Cytotoxan); steroids, such as prednisone ^[8] and dexamethasone; and novel agents, such as Velcade (bortezomib), Revlimid, and thalidomide (Thalomid).

The patients received 120 mg/ m² to 150 mg/m² of Treanda in combination with either prednisone or dexamethasone on days 1 and 2 of a 28-day cycle. Patients received a median of four treatment cycles.

The researchers found that 30 percent of patients responded to treatment, with 2 percent achieving a complete response.

The researchers noted that 27 percent and 31 percent of patients who had been resistant to Revlimid or thalidomide and Velcade, respectively, as their last treatment were responsive to Treanda.

The median duration of response had not been reached at the time of publication. However, the researchers reported that 66 percent of patients remained responsive more than six months from the start of Treanda therapy.

At a median follow-up time of 10 months, 55 percent of patients were alive.

Median time to disease progression was 9.3 months, and median overall survival time was 12.4 months.

The researchers pointed out that data on chromosomal abnormalities were only reported for 37 percent of patients, so they were not able to conclude what effects Treanda treatment might have on patients with high-risk myeloma.

Because safety was not part of the analysis, data on side effects was not collected or reported.

For more information, please see the article in the journal Leukemia and Lymphoma ^[9] (abstract).