Double Transplant Delays Recurrence of Multiple Myeloma

Preliminary results from the 220 patients in the "Bologna 96" trial show that double transplants had an overall response rate of 80% and a median duration of remission of 44 months. For patients who had a single transplant median remission time was 27 months.

With a median follow-up of three years, overall survival did not differ significantly between the two groups: 60 months for the double-transplant patients vs. 56 months for those given standard treatment. Event-free survival, however, was better for patients who had undergone the second transplant (34 months vs. 25 months; P = .05).

Investigators from the Seragnoli Institute of Hematology and Medical Oncology at the University of Bologna told attendees at the American Society of Hematology annual meeting here that based on these data, double autologous transplants are a safe and effective strategy for newly diagnosed patients with multiple myeloma.

The patients will have to be followed longer, however, to determine whether longer time to recurrence of disease will translate into longer life. "The problem with myeloma is, it is still an incurable disease," investigator Patricia Tosi, MD, said at a press conference during the meeting.

The Italian results complemented a French trial that presented its final results earlier in the meeting. Michel Attal, MD, of the Intergroupe Francophone du Myelome reported at a plenary session on Sunday that double transplants improve survival and can be recommended for multiple myeloma patients younger than 60 years.

Seven years after treatment, he said, the probability of survival for patients given two transplants in the earlier trial was double that of patients who only had one autologous transplant (42% vs. 21%, respectively). Event-free survival was also double: 20% vs. 10%.

"There is beginning to be a combination of data which suggest second transplants are the way to go," ASH vice president Stanley L. Schrier, MD, from Stanford University, told reporters, suggesting that the Italian findings could diminish the single-vs.-double controversy.

The posttransplant regimen in Bologna was well tolerated, according to Dr. Tosi, who described oral mucositis as a common problem. Both arms in the trial received the same induction chemotherapy and were maintained with alpha interferon after recovering hematopoiesis following transplantation. Both arms also received a preparatory regimen of 120 mg/m2 of melphalan. For the second transplant, performed three months after the first, patients also received 12 mg/kg of busulfan.

"Our new protocol includes double transplants. I don't know if this can be considered standard of care," Dr. Tosi told Medscape.

She predicted that eventually the question would become not whether double transplants are better than single transplants, but which patients will benefit. "The world is going to identify the patients at risk of these transplants and treat them in a different way," she said, alluding to new therapies in clinical trials for multiple myeloma.

ASH 44th Annual Meeting: Abstracts 7, 669. Presented Dec. 8 and 9, 2002.