ASCO — Elderly patients with newly diagnosed multiple myeloma are likely to survive nearly 2 years longer if thalidomide(Drug information on thalidomide) (Thalomid) is added to the standard melphalan(Drug information on melphalan)/prednisone (MP) regimen, and they may gain about 10 months longer progression-free survival (PFS), French researchers reported at the 42nd Annual Meeting of the American Society of Clinical Oncology (abstract 1). Thierry Facon, MD, professor of hematology, University of Lille, France, reported the findings of the trial (IFM99-06) on behalf of the Intergroupe Francophone de Myelome.
"The results of MP plus thalidomide [MPT] were so superior that enrollment in the study was stopped [after enrollment of 447 patients] so that everyone who was receiving MP alone could have thalidomide added to their treatment," Dr. Facon said.
He noted that median survival with MP in multiple myeloma patients age 65 and older is approximately 3 years, "and new treatment regimens are needed."
Patients in the IFM99-06 study (age 65 to 75) were randomized to receive MP (12 courses at 6-week intervals); MPT (the same MP regimen with thalidomide added at the maximum tolerated dose but no more than 400 mg/d); or stem cell marrow transplant (with a MEL100-based regimen). Clodronate was given to all patients.
"Of note," Dr. Facon commented, "while other studies have evaluated thalidomide in elderly myeloma patients, this study was the first and only study to evaluate thalidomide in combination with MP against both MP alone and stem cell transplantation."
Of the 447 patients, 196 were randomized to the MP arm, 125 to the MPT arm, and 126 to the MEL100 transplant arm.
At 12 months, a complete response was achieved in 2% of the MP arm (as expected), and in 16% and 17% of the MPT and MEL100 arms, respectively (see Table). Dr. Facon noted that the differences between the two experimental arms and the MP arm were "highly significant."
