Abstract
The optimal duration of lenalidomide maintenance post-autologous stem cell transplant (ASCT) in Multiple Myeloma (MM), and choice of therapy at relapse post-maintenance, need further evaluation. This retrospective study assessed outcomes of patients with MM (n = 213) seen at Mayo Clinic, Rochester between 1/1/2005–12/31/2016 who received lenalidomide maintenance post-ASCT. The median PFS was 4 (95% CI: 3.4, 4.5) years from diagnosis of MM; median OS was not reached (5-year OS: 77%). Excluding patients who stopped lenalidomide maintenance within 3 years due to progression on maintenance, ≥3 years of maintenance had a superior 5-year OS of 100% vs. 85% in <3 years (p = 0.011). Median PFS was 7.2 (95% CI: 6, 8.5) years in ≥3 years vs. 4.4 (95% CI: 4.3, 4.5) years in <3 years (p < 0.0001). Lenalidomide refractoriness at first relapse was associated with inferior PFS2 [8.1 (95% CI: 6.4, 9.9) months vs. 19.9 (95% CI: 9.7, 30.2; p = 0.002) months in nonrefractory patients]. At first relapse post-maintenance, median PFS2 was superior with daratumumab-based regimens [18.4 (95% CI: 10.9, 25.9) months] versus regimens without daratumumab [8.9 (95% CI: 5.5, 12.3) months; p = 0.006]. Daratumumab + immunomodulatory drugs had superior median PFS2 compared to daratumumab + bortezomib [NR vs 1 yr (95% CI: 0.5, 1.5); p = 0.004].
Highlights
The current most widely agreed upon frontline treatment strategy for multiple myeloma (MM) involves induction with triplet therapies followed by high-dose chemotherapy and autologous stem-cell transplantation (ASCT) for eligible patients, and maintenance therapy with or without preceding consolidation
The progression-free survival (PFS) and overall survival (OS) data in our uniform cohort was largely comparable to the previously reported outcomes in phase 3 trials studying lenalidomide maintenance
The median PFS in our study was 3 years (i.e., 36 months) from the start of maintenance and 4 years (i.e., 48 months) from diagnosis, which is comparable to the median PFS reported in the Myeloma IX (39 months from randomization), IFM (41 months from randomization), CALGB (46 months from randomization), and GEMIMA (42 months from randomization) studies [1, 3, 4, 6]
Summary
The current most widely agreed upon frontline treatment strategy for multiple myeloma (MM) involves induction with triplet therapies followed by high-dose chemotherapy and autologous stem-cell transplantation (ASCT) for eligible patients, and maintenance therapy with or without preceding consolidation. Lenalidomide is the preferred maintenance strategy following ASCT, especially in non-high-risk patients with MM, and multiple randomized studies (e.g., CALGB100104, IFM2005-02, GEMIMA, Myeloma IX, German multicenter study) have demonstrated an improvement in progression-free survival (PFS) with lenalidomide maintenance [1,2,3,4,5]. While there is no prospective data to guide the optimal duration of lenalidomide maintenance, the current practice consensus is to continue lenalidomide indefinitely until progression or unacceptable toxicity. This is supported by retrospective data from two studies showing improvement in PFS (and OS in one) with a longer duration of lenalidomide maintenance up to 32 months [8, 9]. Parameters Demographics Median age at time of maintenance Gender: Female Disease characteristics
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