COMMENTARY
Role of Maintenance Therapy After Autologous Stem Cell Transplant for Multiple Myeloma: Lessons for Cancer Therapy

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Overall Survival

Although PFS is prolonged in the lenalidomide treatment arms, one must first demonstrate a convincing and meaningful increase in OS before advising maintenance therapy. Progression-free survival can be useful as a regulatory end point when introducing a new drug for the treatment of multiple myeloma; however, a meaningful OS improvement is necessary when evaluating maintenance therapy. Progression-free survival is a valid regulatory end point in myeloma for new drug approval because it is a

Adverse Effects

Lenalidomide is quite well tolerated. Cytopenias, fatigue, and other adverse effects are rather easily managed. However, lenalidomide is a complex immunomodulatory drug. As with any other new drug, we do not know if serious adverse effects will occur in the future. Could there be deleterious effects from lenalidomide that would be recognized only with long-term use? For example, it took 12 years from the introduction of melphalan (1958)5 to the recognition that myelodysplasia/acute leukemia

Quality of Life

Although lenalidomide is quite well tolerated, patients must be followed up by the physician at regular intervals. This entails office visits and blood cell counts. Thus, patients are under close medical surveillance and may feel that they are ill. In contrast, patients who have undergone autologous stem cell transplant need not be followed up so frequently. The modest adverse effects of lenalidomide (eg, fatigue) may also impair the quality of life of patients. Quality-of-life studies need to

Cost

Lenalidomide is an expensive agent, costing a patient in the United States approximately $80,000 to $100,000 annually. Can the medical system afford this cost in a disease for which the physician cannot guarantee a cure?

Consistent Availability and Access to Lenalidomide at Relapse

Unfortunately, in both recent trials, lenalidomide was not routinely given as part of the protocol for patients in the placebo arm at first relapse. It is therefore essential to ensure that patients receiving placebo be given lenalidomide at the time of relapse. Failure to give lenalidomide, even in a subset of patients in the control population, may shorten survival and render the study results difficult to interpret.

Maintenance therapy may be indicated in patients with multiple myeloma who

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