E-Newsletter - February 2017

Alliance Trial Results Lead to FDA Approval of Maintenance Lenalidomide for Myeloma

The drug lenalidomide (Revlimid®) has been approved by the U.S. Food and Drug Administration (FDA) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant (ASCT). The current approval is based on two randomized, controlled trials evaluating the efficacy and safety of lenalidomide maintenance therapy for the treatment of multiple myeloma patients after autologous stem cell transplant (CALGB/Alliance 100104 and Intergroupe Francophone du Myelome /IFM 2005-02 trials).

These trials demonstrated approximately a 15-month (CALGB/Alliance) and 18-month (IFM) progression-free survival advantage, at the time of the primary analysis, in patients treated with lenalidomide compared with patients receiving placebo. The median overall survival was 111 and 106 months for patients treated with lenalidomide compared with 84 and 88 months for patients receiving placebo in the CALGB/Alliance and IFM trials, respectively.

CALGB (Alliance) 100104 was a phase III, randomized, controlled, double-blind, multi-institutional study conducted in 47 locations in the United States. 460 patients with newly diagnosed multiple myeloma - aged between 18 and 70 years - who achieved at least stable disease (SD) or better 100 days after undergoing autologous stem cell transplant (ASCT), were randomized to receive either lenalidomide maintenance or placebo until disease progression, intolerable side effects or death.

IFM 2005-02 was a phase III, controlled, double-blind, multi-institutional study conducted in 77 locations across three countries in Europe. 614 patients with newly diagnosed multiple myeloma younger than 65 years without signs of disease progression within six months of undergoing ASCT, were then randomized to receive a two-month consolidation regimen of lenalidomide monotherapy, followed by either lenalidomide maintenance or placebo until disease progression, intolerable side effects or death.

"Autologous stem cell transplant after induction therapy is part of the continuum of care for transplant-eligible multiple myeloma patients. However, most patients will still see their disease recur or progress after this treatment," said Philip McCarthy, MD, Director of the Blood and Marrow Transplant Center in the Department of Medicine at Roswell Park Cancer Institute. Dr. McCarthy was the Principal Investigator for CALGB (Alliance) 100104 and is Co-Vice Chair of the Alliance Myeloma Committee. "Lenalidomide maintenance therapy, which has been shown to increase progression-free survival following autologous stem cell transplant in clinical trials can be considered a standard of care for these patients."

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The offical title of CALGB (Alliance) 100104: A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma

To learn more about CALGB (Alliance) 100104, see ClinicalTrial.gov Identifier: NCT00114101.

 

For other articles in the February issue of the Alliance E-News newsletter, see below.