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Treanda Shows Promising Activity In Relapsed/Refractory Multiple Myeloma Patients (ASH 2010 Meeting)

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Published: Jan 3, 2011 12:27 pm

Results of a Phase 1 clinical trial suggest that the cancer drug Treanda, in combination with Revlimid and dexamethasone, is highly active and well tolerated in relapsed and refractory multiple myeloma patients.

Dr. Suzanne Lentzsch, of the University of Pittsburgh School of Medicine and Cancer Institute, presented the results of the study at the American Society of Hematology (ASH) 2010 annual meeting in Orlando.

Based on the safety of the Treanda, Revlimid, dexamethasone regimen observed in this study, Dr. Lentzsch believes that this combination may be particularly well suited for older patients or those with a history of peripheral neuropathy (tingling in the arms and legs).

Treanda (bendamustine) is an alkylating agent, which causes cancer cell death by damaging the cancer cells’ DNA.  The drug, developed by Cephalon, is currently approved to treat certain types of leukemia and lymphoma. 

The goal of this study was to determine the maximum tolerated doses of both Treanda and Revlimid (lenalidomide) when administered with dexamethasone (Decadron) for patients with relapsed/refractory multiple myeloma.

A total of 26 patients were enrolled in the study. The patients had received a median of three prior therapies.

During the study, they received 75 mg/m2 Treanda on days 1 and 2 of a 28 day cycle, which was later escalated to 100 mg/m2. Revlimid was administered at 5 mg on days 1 to 21 and was later escalated to 10 mg.  Oral dexamethasone was administered at a fixed dose of 40 mg on days 1, 8, 15, and 22 of each 28-day cycle.  Patients received a maximum of eight treatment cycles. 

Among the evaluated participants, 9 percent achieved a very good partial response and 57 percent achieved a partial response, for an overall response rate of 66 percent. 

Dr. Lentzsch described the time to response as rapid, with half of the patients achieving their best response within 1.8 months.

Median time to progression was 4.3 months.  As of the time of the ASH meeting, Dr. Lentzsch reported that the median overall survival was 10.9 months. However, she noted that the trial is still ongoing and, thus, overall survival could still change.

Low blood cell counts were common with this regimen.  Forty eight percent of patients experienced low white blood cell counts, 28 percent low platelet levels, and 20 percent low red blood cell counts.

Dr. Lentzsch pointed out that she and her colleagues did not observe any severe non-blood related side effects. The most common side effect that was not blood-related was fatigue. The study authors did not observe any case of severe peripheral neuropathy in this trial.

Based on the observed side effects at each dosing regimen, the maximum tolerated dose, when administered with dexamethasone, was determined to be 75 mg/m2 Treanda and 10 mg Revlimid.

For more information, please see abstract 989 on the American Society of Hematology annual meeting website.

Photo by Robert S. Donovan on Flickr - some rights reserved.
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