Speaker: Sundar Jagannath, MD, Chief, Bone Marrow and Blood Stem Cell Transplantation, St. Vincent’s Comprehensive Cancer Center, New York, New York

Bortezomib (Velcade®, Millennium), a first-in-class protea-some inhibitor, appears to be a promising therapeutic modality for the first-line treatment of previously untreated patients with multiple myeloma.

A total of 42 treatment-naive patients were enrolled in a phase 2 trial. They received bortezomib 1.3 mg/m2 twice weekly for the first two weeks of a three-week cycle, for a maximum of six cycles. Patients achieving less than a partial response (PR) after two cycles or less than a complete response (CR) after four cycles were given oral dexametha-sone 40 mg on the day of and on the day after each bortezomib dose. The primary endpoint was the response rate.
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Neurological assessments, including nerve conduction tests, were performed, and stem cells for transplantation-eligible candidates were harvested at the discretion of the physician.

At the time of this writing, 32 patients were evaluable for response. The overall response rates were 88% for patients achieving CRs and 25% for those achieving near-CRs. Six of eight patients (75%) achieved CRs or near-CRs with bor-tezomib therapy alone.

Stem-cell harvesting and engraftment were successful in 100% of patients (in eight of eight), and all transplant patients made complete hematological recoveries.

Adverse drug events were similar to those previously observed with bortezomib in other clinical trials. Toxicities (i.e., peripheral neuropathy, gastrointestinal events, fatigue, and hematological effects such as neutropenia) were manageable and reversible.

Thalidomide for Myeloma

Speaker: Michel Attal, MD, Hematologist/Oncologist, Hema-tology Service, Purpan Hospital, Toulouse, France

Thalidomide (Thalomid®, Celgene) appears to be a new and effective maintenance treatment after high-dose therapy with autologous stem cell transplantation (ASCT) in patients with myeloma. For patients with aggressive myeloma, high-dose therapy with ASCT is generally used, but because most of these patients still experience relapse, new strategies are being tested to manage residual disease.
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The Intergroupe Francophone du Myeloma (IFM) instituted a trial to evaluate the impact of maintenance therapy with thalidomide on the duration of response after high-dose therapy. From April 2000 to October 2003, 1,004 myeloma patients younger than 65 years of age at the time of diagnosis were enrolled in the IFM99 study protocol. Of these, 780 patients, without any or with only one adverse prognostic factor, received three or four cycles of standard chemotherapy and two autologous transplants. The first cycle consisted of melpha-lan (Alkeran®, GlaxoSmithKline) 200 mg/m2, and the second consisted of melphalan 400 mg/m2.

A total of 580 patients (79%) were without progressive disease after two months and were randomly assigned to receive (1) no maintenance treatment, (2) maintenance treatment with pamidronate disodium for injection (Aredia®, Novartis), (3) a standard therapy used to treat bone diseases, or (4) maintenance treatment with thalidomide plus pamidronate.

At 40 months after their diagnosis, thalidomide improved progression-free survival and event-free survival rates. The probability of progression-free survival was 70% in the thalido-mide patients, 53% in the pamidronate-alone patients, and 52% in the patients receiving no maintenance treatment. Approximately 60% of patients in the latter two study groups were given thalidomide at the time of relapse, so overall survival was similar in all three treatment groups.