Myeloma and other monoclonal gammopathies - Clinical
Cyrille Hulin, Philippe Moreau, Michel Attal, Karim Belhadj, et al.
Conclusion: Stem cell mobilization and collection was feasible with D-VTd induction. Adding daratumumab to VTd allowed successful transplantation in patients with NDMM who were transplant eligible.
Cyrille Hulin, Thierry Facon, Shaji Kumar, Torben Plesner, et al.
Conclusion: D-Rd patients received less lenalidomide compared with the Rd group regardless of age. Efficacy of D-Rd in <75 and ≥75 y patients was consistent with the ITT population, and D-Rd demonstrated a manageable safety profile regardless of age. Together with the phase 3 ALCYONE study, these studies confirm the clinical benefit of daratumumab plus standard-of-care in transplant-ineligible NDMM patients ≥75 y of age.
Donna Reece, Nizar J. Bahlis, Christy Samaras, Michael Sebag, et al.
Conclusion: In patients with RRMM who received POM + LoDEX + DARA after first- or -second-line LEN based treatment, HRQoL was maintained or trended toward improvement, despite the combination of 3 drugs with distinct toxicity profiles. In context with the previously reported safety and efficacy data from cohort B of MM-014, the results of this HRQoL analysis further support the earlier use of POM-based treatment in RRMM immediately following treatment with LEN.
Meletios Dimopoulos, Dominik Dytfeld, Sebastian Grosicki, Philippe Moreau, et al.
Conclusion: In this extended FU of ELOQUENT-3, EPd demonstrated sustained and clinically relevant PFS and OS benefits vs Pd, with no new safety signals. These data support the long-term favorable efficacy–safety profile of EPd and suggest this regimen could be considered as a standard of care for pts with relapsed/refractory MM after failure of len and a PI.
Meletios Dimopoulos, Katja Weisel, Philippe Moreau, Larry D. Anderson Jr, et al.
Pomalidomide + Bortezomib + Low-Dose Dexamethasone vs Bortezomib + Low-Dose Dexamethasone After One Prior Line of Therapy in Patients With Lenalidomide-Pretreated Multiple Myeloma: Subgroup Analysis of the Phase 3 OPTIMISMM Trial
Conclusion: In LEN-refractory and -nonrefractory pts after 1 prior LOT, PVd reduced the risk of progression and death by 45% and 46% vs Vd, respectively. Further, in both subgroups, second-line Tx with PVd significantly improved ORR and led to deeper responses compared with Vd. TEAEs with PVd therapy were generally consistent with the known profiles of POM, BORT, and DEX. These data further demonstrate that PVd is effective and tolerable in pts for whom LEN is no longer a Tx option, including LEN-refractory pts, supporting its use as second-line therapy in RRMM.
Katja Weisel, Karthik Ramasamy, Melody Owen, Sujith Dhanasiri, Andrew Frederickson, Thierry Facon
Conclusion: Despite limited follow-up for recent trials, the Bayesian framework employed in this study allows for a probabilistic interpretation suggesting that, of the included regimens, RVd and Rd+D are most likely to prolong OS and PFS, respectively, in patients with NDMM not intended for ASCT. Further evidence for the new regimens is needed to confirm their long-term benefit over the current routine standards of care.
Sabrina Trudel, Benoît Tessoulin, Maxime Jullien, Nicolas Blin, et al.
Conclusion: This real-life study demonstrated that PCD is therefore a manageable, cost-effective and oral triplet combination for unselected RRMM patients eligible to Pd.
Hartmut Goldschmidt , Gordon Cook , Philippe Moreau , Clara Chen , Catherine Davis
Conclusion: In France, Germany, Italy, and the UK, Pd-based regimens were rarely used as 2L therapy; however, the proportion of pts receiving these regimens increases with increasing line of therapy, and Pd or Pd-based triplets are used in more than a quarter of pts in 3L and above. Only a small proportion of pts received Pd-based triplets, particularly in 3L and above, and given the aforementioned durable improvement in outcomes conferred by these triplets, they may be an option for RRMM pts who have received at least two prior therapies and are refractory to lenalidomide and PIs.
Mohammed El Shazly, Abdel Aziz Belal, Mohammed Farouk, Samer Srour, et al.
Conclusion: maintenance had proven its efficacy in controlling myeloma with increased PFS and improved OS. The type of maintenance used although did not reach statistical significance but combing P.I and IMID shows promise, keeping patients on maintenance for more than 3 years had a significant advantage in PFS and OS and should be exploited in future randomized controlled trials.
Rakesh Popat, Joanna B. Opalinska, Laurie Eliason, Jenny Wilson, et al.
Conclusion: The PRO diary data and the exit interview results suggest that patients experienced improvements in fatigue and bone pain during the study in keeping with high response rates. Although visual symptoms were frequent with treatment, they were manageable and improving post-treatment. Overall patients had a high level of satisfaction with treatment. This study was limited by small sample sizes but provides valuable preliminary insight into the patient experience of GSK2857916. The impact on patient symptoms, functioning, and tolerability will be further explored in future studies.
Maria-Victoria Mateos, Shaji Kumar, Veronica Gonzalez, Meletios Dimopoulos, et al.
Conclusion: We have developed a risk stratification model for SMM that incorporates revised cutoffs for previously used parameters (20/2/20) that can be universally applied. Additonal analysis are being conducted to develop models that utilize common cytogenetic abnormalities, as well as those without FLC given lack of availability of all tests across the world.
Hartmut Goldschmidt, Meletios A. Dimopoulos, S. Vincent Rajkumar, Katja C. Weisel, et al.
Conclusion: Post-ASCT maintenance with ixazomib resulted in a significantly higher rate of deepening response vs placebo; deepening response was associated with prolonged PFS. Ixazomib resulted in non-significant PFS benefit vs placebo in VGPR/PR pts with and without deepening response; prolonged follow-up would be needed to confirm these results.