PHILADELPHIAFinal data from a French prospective randomized trial show
that high-dose therapy and double autologous transplantation improves
survival of younger patients with multiple myeloma.
The results were reported in the plenary session at the 44th Annual
Meeting of the American Society of Hematology (abstract 7).
Michel Attal, MD, reporting for the Intergroupe Francophone du Myelome (IFM),
said that double transplant increased 7-year event-free survival to 20% and
7-year overall survival to 42%, twice the results seen in patients randomized
to single transplant.
Subgroups most likely to benefit from double transplant include those who
fail to achieve at least a partial response after the initial regimen and
those who fail to achieve at least a good partial response (defined as more
than 90% reduction of the M component on electrophoresis) after the first
graft, said Dr. Attal, of the Hopital Purpan, Toulouse.
"After high-dose therapy supported with a single autologous stem cell
transplant, almost all patients ultimately relapse," Dr. Attal said. "In
order to improve these results, the role of double transplantation has been
evaluated in uncontrolled studies, but these cannot be directly compared to
the results after single transplant because of selection bias such as age,
performance status, and renal function. Our multicenter, prospective,
randomized trial was designed to avoid these sources of bias and to compare
the effects of single transplant and double transplant."
The investigators enrolled 399 previously untreated myeloma patients under
the age of 60 years. Patients were randomized at diagnosis to receive either
single transplant or double transplant.
Single transplant patients were prepared with melphalan (140 mg/m2) and
total body irradiation (TBI) at 8 Gy. Patients randomized to double
transplant were prepared with melphalan alone (140 mg/m2) for the first
transplant and with melphalan (140 mg/m2) and TBI (8 Gy) for the second
transplant. All patients were initially treated with three to four cycles of