Abstract
Autologous stem cell transplantation (ASCT) combined with novel agents is the standard treatment for transplant-eligible, newly diagnosed myeloma (NDMM) patients. Lenalidomide is approved for maintenance after ASCT until progression, although the optimal duration of maintenance is unknown. In this trial, 80 patients with NDMM received three cycles of lenalidomide, bortezomib, and dexamethasone followed by ASCT and lenalidomide maintenance until progression or toxicity. The primary endpoint was the proportion of flow-negative patients. Molecular response was assessed if patients were flow-negative or in stringent complete response (sCR). By intention to treat, the overall response rate was 89%. Neither median progression-free survival nor overall survival (OS) has been reached. The OS at 3 years was 83%. Flow-negativity was reached in 53% and PCR-negativity in 28% of the patients. With a median follow-up of 27 months, 29 (36%) patients are still on lenalidomide and 66% of them have sustained flow-negativity. Lenalidomide maintenance phase was reached in 8/16 high-risk patients but seven of them have progressed after a median of only 6 months. In low- or standard-risk patients, the outcome was promising, but high-risk patients need more effective treatment approach. Flow-negativity with the conventional flow was an independent predictor for longer PFS.
Highlights
Autologous stem cell transplantation (ASCT) combined with novel agents is the standard treatment for transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients
The three randomized controlled trials (RCTs) evaluating lenalidomide maintenance were included in a meta-analysis [5] which demonstrated a significant progression-free survival (PFS) and overall survival (OS) benefit with lenalidomide maintenance after ASCT when compared with placebo or observation
Based on the meta-analysis, the risk of death due to secondary primary malignancies (SPMs) was similar between lenalidomide and placebo or observation groups but there was a 34% reduction in risk to die of multiple myeloma (MM) in lenalidomide maintenance arm [5]
Summary
Autologous stem cell transplantation (ASCT) combined with novel agents is the standard treatment for transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients. The three randomized controlled trials (RCTs) evaluating lenalidomide maintenance were included in a meta-analysis [5] which demonstrated a significant PFS and OS benefit with lenalidomide maintenance after ASCT when compared with placebo or observation. The impact of minimal residual disease (MRD) negativity for PFS and OS has been demonstrated in several trials [9,10,11,12,13,14] and it is recommended for one of the primary endpoints for evaluating the approval of new drugs for MM [9, 15] This phase 2 trial of the Finnish Myeloma Group (FMGMM02) was designed to investigate the rate of serological responses, proportion of flow-MRD-negative (10-4) patients and patients in molecular remission (10-5) after RVD induction followed by ASCT, and lenalidomide maintenance in NDMM patients. The study included a randomized stem cell mobilization with CY plus filgrastim or filgrastim alone in order to examine the success of stem cell mobilization after lenalidomide-based induction
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