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John Theurer Cancer Center researchers shed light on new multiple myeloma therapy
Date:7/25/2012

c disease. Patients received CRd induction therapy in 28-day cycles for up to eight cycles or until disease progression or unacceptable toxicity. After eight cycles, patients received maintenance CRd for up to 24 cycles and then moved to a single-agent lenalidomide.

During phase 1, the primary endpoints were safety and determination of the maximum tolerated dose of carfilzomib within the context of CRd combination therapy. Carfilzomib doses were escalated, while lenalidomide and dexamethasone were given at standard low-dose induction levels. Once the maximum tolerated dose of carfilzomib was reached, the researchers began Phase II with a primary endpoint of near complete response (nCR). Secondary endpoints were overall response rate, time on study, duration of response, progression-free survival (PFS), time to progression, overall survival and overall treatment toxicity.

Study results indicated that patients experienced a rapid and good initial response to CRd, and their responses improved as the trial continued. Of the 49 patients who completed four treatment cycles, 67 percent achieved at least nCR, with 45 percent in stringent complete response (sCR), defined as no detectable tumor cells or myeloma protein in the blood or bone marrow. Of the 36 patients who completed eight or more treatment cycles, 78 percent achieved nCR with 61 percent in sCR. Overall, 62 percent of trial participants achieved at least nCR, with 42 percent achieving sCR. The investigators also found PFS rates were 97 percent at 12 months and 92 percent at 24 months. All patients who achieved sCR continued to respond to therapy for a median of nine months, demonstrating the durability of responses to this regimen. Importantly, these periods of extended treatment were well tolerated, including low rates of peripheral neuropathy, a treatment-limiting side effect of bortezomib, the first-generation proteasome inhibitor.

Bortezomib is currently FDA approved to treat adv
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Contact: Amy Leahing
aleahing@p4strategy.com
305-458-0599
John Theurer Cancer Center
Source:Eurekalert

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