Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) Alone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of the Phase 3 Alcyone Study

Mateos, María‐Victoria; San-Miguel, Jesús F.; Cavo, Michèle; Creixenti, Joan Bladé; Suzuki, Kenshi; Jakubowiak, Andrzej; Knop, Stefan; Doyen, Chantal; Lúcio, Paulo; Nagy, Zsuzsanna; Pour, Luděk; Grosicki, Sebastian; Crepaldi, Andre H; Liberati, Anna Marina; Campbell, Philip; Shelekhova, Tatiana; Yoon, Sung‐Soo; Iosava, Genadi; Fujisaki, Tomoaki; Garg, Mamta; Pei, Huiling; Krevvata, Maria; Carson, Robin; Borgsten, Fredrik; Dimopoulos, Meletios A.

doi:10.1182/blood-2022-163347

Cited by 9 publications

(8 citation statements)

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“…These trials reported that up to a third of patients achieved MRD negativity including a subset with sustained negativity status 42 . Higher MRD‐negativity rates were associated with prolonged OS and PFS in transplant‐ineligible patients regardless of age 43 , 44 . Sustained MRD negativity is one of the treatment goals pursued by cooperative groups as a biomarker during maintenance and for considering treatment discontinuation for myeloma patients regardless of transplantation status 19 , 26 .…”

Section: Discussionmentioning

confidence: 99%

Measurable Residual Disease Testing in Multiple Myeloma Routine Clinical Practice: A Modified Delphi Study

Ramasamy,

Avet-Loiseau,

Hveding Blimark

et al. 2023

HemaSphere

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We used a modified Delphi approach to establish areas of consensus and nonconsensus regarding the utility of determining measurable residual disease (MRD) to assess multiple myeloma (MM) treatment response, which may inform disease management and design of future clinical trials. This modified Delphi study incorporated 2 iterative rounds of surveys to evaluate the opinions of an expert panel of 61 practicing hematological oncologists from across 14 countries in Europe concerning the use of MRD testing in MM management. Survey 1 assessed experts’ opinions on MRD testing in different clinical situations and associated challenges. Survey 2 focused on the lack of consensus areas identified in survey 1. Consensus to an individual question was defined a priori as 75% agreement or disagreement by the panel. From the 2 rounds of surveys, the experts reached consensus agreement that MRD testing should be performed in newly diagnosed or relapsed patients who achieved complete response (CR) or better after transplantation. In transplant-ineligible patients, experts recommended MRD testing in those who are ≤70 years old and in CR. If a patient was previously positive on positron-emission tomography and computed tomography (PET/CT), both MRD and PET/CT should be assessed at CR. MRD testing should be performed ≤6 months after transplantation and every 6–12 months in continuously treated patients in CR. There was no consensus on making treatment decisions based on MRD status. MRD testing is an important component of clinical management in MM. Additional data will further clarify the role of MRD in guiding treatment decisions.

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Section: Discussionmentioning

confidence: 99%

Measurable Residual Disease Testing in Multiple Myeloma Routine Clinical Practice: A Modified Delphi Study

Ramasamy,

Avet-Loiseau,

Hveding Blimark

et al. 2023

HemaSphere

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“…Patients who were enrolled in a trial during this period had a median OS of 87 months, which is a remarkable milestone. The ALCYONE trial reported a median OS of 82.7 months for the experimental group [41], while the experimental group in the MAIA trial had a 60-month OS rate of 66.6% [42].…”

Section: Discussionmentioning

confidence: 99%

Outcomes of Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma According to Clinical Trials Enrollment: Experience of a Single Institution

Rodríguez-Lobato,

Tovar,

de Daniel

et al. 2023

Cancers

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The proportion of non-transplant-eligible (NTE) newly diagnosed multiple myeloma (NDMM) patients excluded from clinical trials (CTs) and their prognosis is unknown. CT results may not be generalizable to real-world practice due to strict recruitment criteria. We analyzed causes of NTE-NDMM patient exclusion form CTs and their outcomes. A total of 211 NTE-NDMM patients were included. They were divided into three periods: 2003–2007, 2008–2012, and 2013–2017. Overall, 50% received non-trial treatment (NCT), while 50% participated in a CT (20% control group (CG) and 30% experimental group (EG)). Main causes for exclusion from CTs were comorbidities, ECOG > 2, and renal insufficiency. In the first two periods, the CR rate was similar regardless of treatment type, but in the last period, the EG group showed improved CR. Median PFS was similar in the first two periods, with a benefit seen only in the EG in the last period. The median OS was significantly longer in CT-included patients compared to NCT group in the last two periods. Conclusions: The presence of comorbidities and worsened ECOG were the main reasons for CT exclusion. Patients included in CTs had a longer OS than NCT. This OS benefit may be influenced by a selection bias, making it challenging to generalize CT results to real clinical practice.

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“…The phase three ALCYONE trial [ 14 ] studied the association dara-MPV vs. MPV; median PFS was higher for patients in the daratumumab group (36.4 vs. 19.3 months, p < 0.0001) in the primary analysis (median follow-up of 16.5 months) ( Table 1 ; Figure 1 ). Moreover, in the last update of the results, with a median follow-up of 74 months, median OS was significantly more important with daratumumab (82.7 vs. 53.6 months, p < 0.0001) [ 15 ]. In the daratumumab group, 28.3% of the patients achieved minimal residual disease (MRD) negativity (10 −5 sensitivity threshold) as compared with 7% of the control group ( p < 0.001).…”

Section: The Rise Of Anti-cd38 Monoclonal Antibodiesmentioning

confidence: 99%

30 Years of Improved Survival in Non-Transplant-Eligible Newly Diagnosed Multiple Myeloma

Chacon

Leleu

Bobin

2023

Cancers

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The treatment of multiple myeloma (MM) has greatly evolved these past few years. Recent advances in therapeutics have largely benefited elderly patients now renamed “non-transplant-eligible” (NTE) patients. Since the 1960s, and for several decades, chemotherapy was the only treatment for MM. Then, the field was marked by the emergence of targeted therapies in the 2000s, such as immunomodulating agents (thalidomide, lenalidomide, and pomalidomide) and proteasome inhibitors (bortezomib, carfilzomib, and ixazomib), which were the first steps towards an increase in survival. Thereafter, the apparition of monoclonal antibodies (mAbs) was considered a milestone in the treatment of MM for both transplant-eligible and NTE patients. Anti-CD38 mAbs can be safely administered to older patients with an impressive efficacy leading to a never-achieved-before survival rate with the triple association of anti-CD38 mAbs, lenalidomide, and dexamethasone. However, progress is still expected with the introduction in the armamentarium for NTE patients of the most recent innovative immunotherapy-based treatments newly introduced in MM, e.g., CAR-T cells and bispecific antibodies. These “improved versions” of immune-based treatments will probably also benefit NTE patients, although further studies will be needed to better understand their role in this population.

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Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) Alone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of the Phase 3 Alcyone Study

Cited by 9 publications

References 0 publications

Measurable Residual Disease Testing in Multiple Myeloma Routine Clinical Practice: A Modified Delphi Study

Measurable Residual Disease Testing in Multiple Myeloma Routine Clinical Practice: A Modified Delphi Study

Outcomes of Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma According to Clinical Trials Enrollment: Experience of a Single Institution

30 Years of Improved Survival in Non-Transplant-Eligible Newly Diagnosed Multiple Myeloma

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