A Phase I Trial of High-Dose Lenalidomide and Melphalan as Conditioning for Autologous Stem Cell Transplantation in Relapsed or Refractory Multiple Myeloma.
Autologous stem cell transplantation (ASCT) conditioned with high-dose chemotherapy has long been established as the standard of care for eligible patients with newly diagnosed multiple myeloma. Despite recent therapeutic advances, high-dose melphalan (HDM) remains the chemotherapy regimen of choice in this setting. Lenalidomide (LEN) in combination with low-dose dexamethasone is recognized as a standard of care for patients with relapsed or refractory multiple myeloma (RRMM), and there is growing support for the administration of LEN as maintenance therapy post-ASCT. In view of the above, the present phase I clinical trial was designed to evaluate the safety and tolerability of high-dose LEN (HDLEN) in patients with RRMM, and to determine the maximum tolerated dose of HDLEN when added to HDM before ASCT. Despite administering HDLEN at doses of up to 350 mg/day, the maximum tolerated dose could not be determined, owing to an insufficient number of dose-limiting toxicities in the 21 patients enrolled in the trial. Conditioning with HDLEN plus HDM was associated with a favorable tolerability profile. Adverse events following ASCT were as expected with HDM. Median progression-free and overall survival were 10 months and 22 months, respectively, in this population of heavily pretreated patients. Our findings suggest that HDLEN in combination with HDM may offer significant potential as a conditioning regimen before ASCT in patients with RRMM. These preliminary findings are now being evaluated further in an ongoing phase II clinical trial.
['Mark|Tomer M|TM|', 'Guarneri|Danielle|D|', 'Forsberg|Peter|P|', 'Rossi|Adriana|A|', 'Pearse|Roger|R|', 'Perry|Arthur|A|', 'Pekle|Karen|K|', 'Tegnestam|Linda|L|', 'Greenberg|June|J|', 'Shore|Tsiporah|T|', 'Gergis|Usama|U|', 'Mayer|Sebastian|S|', 'Van Besien|Koen|K|', 'Ely|Scott|S|', 'Jayabalan|David|D|', 'Sherbenou|Daniel|D|', 'Coleman|Morton|M|', 'Niesvizky|Ruben|R|']
D000328:Adult D000368:Aged D005260:Female D018380:Hematopoietic Stem Cell Transplantation D006801:Humans D000077269:Lenalidomide D008297:Male D020714:Maximum Tolerated Dose D008558:Melphalan D008875:Middle Aged D009101:Multiple Myeloma D016879:Salvage Therapy D016019:Survival Analysis D013792:Thalidomide D019172:Transplantation Conditioning D014182:Transplantation, Autologous
Lenalidomide Melphalan Autologous stem cell transplantation Relapsed and refractory multiple myeloma