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Dr. Jagannath - A Phase II Study of Bortezomib (Velcade®), Cylophosphamide (Cytoxan®), Thalidomide (Thalomid®) and Dexamethasone as First-Line Therapy for Multiple Myeloma
Sundar Jagannath, MD
St. Vincent's Comprehensive Cancer Center
New York, New York
Member, IMF Board of Scientific Advisors

"This was designed so that this treatment would be widely applicable....so all patients should be able to receive this therapy."
Dr. Sundar Jagannath

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[188] A Phase II Study of Bortezomib (Velcade), Cylophosphamide (Cytoxan), Thalidomide (Thalomid) and Dexamethasone as First-Line Therapy for Multiple Myeloma. Session Type: Oral Session

Sundar Jagannath, Bill Bensinger, Robert Vescio, Elber Camacho, Jeffrey Wolf, David Irwin, Gerardo Capo, Marti McKinley, David H. Vesole, Amitabha Mazumder, John Crowley, Dixie Esseltine, Brian Durie St. Vincents Comprehensive Cancer Center, New York, NY, USA; Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Cedars-Sinai Outpatient Cancer Center, Los Angeles, CA, USA; Comprehensive Cancer Center of the Desert, Palm Springs, CA, USA; University of California, San Francisco, CA, USA; Alta Bates Summit Comprehensive Cancer Center, Berkeley, CA, USA; Trinitas Comprehensive Cancer Center, Elizabeth, NJ, USA; Research, Aptium Oncology Research Network, Beverly Hills, CA, USA; Center for Research and Biostatistics, Seattle, WA, USA; Millennium Pharmaceuticals, Cambridge, MA, USA

Background: A phase II trial evaluating the response rate with sequential administration of Bortezomib, cyclophosphamide, and dexamethasone (3 cycles) followed by Bortezomib, Thalidomide, and dexamethasone (3 cycles). The primary endpoints are overall response, achievement of very good partial response (VGPR), as well as assessment of safety and tolerability. This report provides results for 25 of 43 planned eligible pts. Methods: Pts with newly diagnosed, untreated symptomatic myeloma were eligible. Treatment consisted of three 21-day cycles of Bortezomib 1.3mg/m2 days 1, 4, 8, and 11, Cyclophosphamide 300mg/m2 IV days 1 and 8 and dexamethasone 40mg po or IV days 1, 2, 4, 5, 8, 9, 11, 12; followed by three 21-day cycles of Bortezomib 1.0 mg/m2 days 1, 4, 8, and 11; Thalidomide 100 mg po daily and dexamethasone as before. Pts received thrombosis prophylaxis with ASA cycles 4-6. Upon completion of the 6 courses, pts proceeded to stem cell harvest and/or maintenance therapy. Responses were assessed by International Response Criteria. Results: As of August 2007, 25 pts have been enrolled: median age 60 years; 65% male; 75% Stage III (D/S); IgG 66%, IgA 16%; 17% light chain only. All pts fully evaluable for response thus far (13/13 [100%]) have achieved at least PR. Of these, 7/13 (54%) have achieved VGPR (with nCR/CR in 31%). The median time to PR was 2 cycles or 42 days. Maximum response occurred by cycle 4 for 12/13 (92%)pts. Overall, both components of the sequential regimen were very well tolerated. One pt had a ruptured colonic diverticulum related to dexamethasone, but recovered well and achieved nCR on trial. There have been 24 therapy attributed toxicity events Grade 2 of which 11 have required drug/schedule adjustments: 3 each for cyclophosphamide (neutropenia), dexamethasone (hyperglycemia, pneumonia, perforated viscus) and Thalidomide (neuro related) plus 2 for Bortezomib (neuropathy). No deep vein thromboses (DVT) have occurred in the study. 3 pts have already proceeded to successful stem cell harvest with transplant planned. Conclusion: The addition of cyclophosphamide and Thalidomide to Bortezomib/dexamethasone combination has improved the depth of response with VGPR (54%) and CR/nCR (31%) compared to our previous 2-drug experience which produced VGPR (38%). This very well tolerated new regimen is potentially an important step forward with further results and confirmation available by December 2007.

Abstract #188 appears in Blood, Volume 110, issue 11, November 16, 2007

Keywords: Complete Remission|Induction Chemotherapy|Stem Cell Collection

Disclosure: Consultancy: Millennium Pharmacueticals - Advisory Board Consultant; Celgene Pharmaceuticals - Advisory Board Consultant. Honoraria Information: Millennium Pharmaceuticals - Advisory Board Consultant; Celgene Pharmaceuticals - Advisory Board Consultant. Membership Information: Millennium Pharmaceuticals and Celgene Pharmaceuticals. Off Label Use: Bortezomib in newly diagnosed patients with Multiple Myeloma.

Monday, December 10, 2007 7:45 AM

Session Info: Simultaneous Session: Myeloma: Frontline Therapy in Newly Diagnosed Multiple Myeloma (7:30 a.m.-9:00 a.m.)

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