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Thalidomide Added to Standard Therapy Reduces Risk of Multiple Myeloma Recurrence: Presented at ASCO

By Paula Moyer

ORLANDO, FL -- May 18, 2005 -- Use of thalidomide in combination with standard chemotherapy appears to reduce the risk of recurrence in patients with newly diagnosed multiple myeloma, researchers reported here May 16^th at the American Society of Clinical Oncology Annual Meeting (ASCO).

"The findings … show that myeloma does not have to be a death sentence," said principal investigator Bart Barlogie, MD, PhD, professor of medicine and pathology, University of Arkansas for Medical Sciences, and director, Myeloma Institute for Research and Therapy, Little Rock, Arkansas.

In their prospective, phase 3 trial, Dr. Barlogie and colleagues randomized patients with newly diagnosed multiple myeloma to 1 of 2 treatment arms: 345 patients received standard treatment (Total Therapy II protocol), which consisted of induction, transplant 1 and 2, and consolidation with dexamethasone, cisplatinum, adriamycin, cyclophosphamide, and etoposide; 323 patients additionally received thalidomide during consolidation.

All patients whose myeloma remained in remission between 4 and 12 weeks after consolidation therapy were given a final maintenance regimen designed to keep the myeloma in long-term remission.

Although more patients in the thalidomide group had deep vein thrombosis, treatment with low molecular weight heparin (Calciparine) reduced the frequency of events, Dr. Barlogie noted.

In the total cohort, 39% of subjects were at least 60 years old, 59% were men, and 33% had karyotype abnormalities. Their disease status was as follows: 31% had beta-microglobulin levels of at least 4 mg/L; 15% had albumin levels below 3.5 g/dL, and 30% had lactate dehydrogenase levels of at least 190 U/L. Immunoglobulin A isotype was observed in 24% of subjects, and 14% had a plasma cell labeling index of at least 1%.

After the treatment phase, the event-free survival rate (the study's primary endpoint) increased from 40% to 50% in the thalidomide arm.

After 4 cycles of intensive reduction chemotherapy were completed, patients underwent autologous stem cell transplantation; 85% completed the first transplantation cycle and 67% completed the second.

At 1 year, total remission was 1.4% in the overall group, and the overall rate of incomplete and complete pathological remission was 67%; 47% achieved a complete response.

After a median follow-up of 35 months, 62% of patients in the thalidomide arm had complete remission compared with 43% of controls.

Overall 5-year survival rates were similar in the 2 groups -- 68% in the thalidomide and 63% among controls.

When patients on thalidomide were treated with heparin, the rate of deep vein thrombosis decreased from 34% to 24% (P = .06). Patients in the thalidomide group had a higher rate of peripheral neuropathy than controls (12% vs 4%, P = .001). Among patients with neuropathy, 21% of thalidomide patients and 13% of controls had motor neuropathy (P = .01).

The findings from this study suggest that thalidomide might be beneficial in the treatment of multiple myeloma as an addition to standard chemotherapy, the researchers concluded.


[Presentation title: Results of Total Therapy 2 (TT2). A Phase III Randomized Trial, to Determine the Role of Thalidomide (THAL) in the Upfront Management of Multiple Myeloma (MM). Abstract LBA6502]

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