Intravenous daratumumab (DARZALEX®), a human monoclonal antibody targeting CD38, is approved in the EU and USA for use in combination with bortezomib, thalidomide and dexamethasone for the treatment of adults with newly diagnosed multiple myeloma (MM) who are eligible for autologous stem cell transplantation. A subcutaneous formulation of daratumumab has also been approved in the EU and USA (DARZALEX FASPRO™) for use in MM. In the pivotal phase III CASSIOPEIA trial in adults with newly diagnosed, transplant-eligible MM, the addition of intravenous daratumumab to bortezomib, thalidomide and dexamethasone significantly increased the proportion of patients with a stringent complete response and significantly prolonged progression-free survival; overall survival data are not yet mature. Some facets of health-related quality of life were improved by the addition of daratumumab. The addition of daratumumab had a minimal effect on overall toxicity and the most common grade ≥ 3 adverse events with daratumumab combination therapy were haematological (e.g. neutropenia, lymphopenia). The approval of daratumumab as combination therapy in patients with newly diagnosed, transplant-eligible MM expands the range of MM treatment settings in which daratumumab is an option and the availability of the subcutaneous formulation will likely be of benefit to patients.

Daratumumab: A Review in Combination Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma

This article presents a practical overview of the treatment of younger, newly diagnosed multiple myeloma patients, focusing on novel treatment strategies. With the introduction of effective new agents, multiple myeloma is one of the most active and changing fields in clinical oncology. In addition, monitoring technology has become reliable and practical. Achieving and sustaining minimal residual disease negativity (MRD– ), such as multiparameter flow cytometry (MFC) < 10−5, is one of the goals of therapy. MRD–  is significantly associated with prolonged progression-free survival, whereas MRD persistence (MRD +) is an independent factor for poor progression-free survival. Evidence from several recent studies evaluating modern therapy has further supported the positive correlation between depth of response and outcomes. Multiple myeloma can become a chronic illness with sustained MRD– in a significant number of patients. Our ultimate hope is to leverage tumoricidal-immunomodulatory sequential therapies and to cure a subset of our patients.

Latest treatment strategies aiming for a cure in transplant-eligible multiple myeloma patients: how I cure younger MM patients with lower cost.

Introduction: Monoclonal antibodies (MoAbs) are rapidly changing the therapeutic scenario of multiple myeloma. Most of the available data, however, come from studies performed in patients with relapsed or refractory disease.Area covered: Here, the most recent results from clinical trials that have investigated (or are investigating) efficacy and safety of MoAbs as front-line treatments in both transplant-eligible and not-eligible patients with newly diagnosed multiple myeloma, as well as in smoldering myeloma, are reviewed. PubMed reported articles before 28 March 2020, and abstracts presented at the last ASCO, ASH, EHA, and IMW meetings were considered. Among others, pertinent data regarding daratumumab, isatuximab, elotuzumab, and pembrolizumab will be analyzed.Expert opinion: Introduction of MoAbs as first-line therapy will likely provide a significant improvement in the clinical outcome of patients with multiple myeloma. This will also require an appropriate re-positioning of salvage therapies. The role of MoAbs in smoldering myeloma appears to be promising, but adequate follow-up is needed.

Monoclonal antibodies in newly diagnosed and smoldering multiple myeloma: an updated review of current clinical evidence.

According to European authors, patients with multiple myeloma (MM) and high cytogenetic risk have shorter values of progression free survival (PFS) and overall survival (OS) as compared with standard hazard. More frequent hospitalizations mean potentially high expenses associated with management of patients with unfavorable cytogenetic risk. Cost and availability of treatment of oncological patients relate to one of pressing ethical issues. Another important aspect of this issue consists in an effective use of available approved modes of therapy in patients with various survival prognosis, which is especially critical for early lines of therapy. It has been proven that early administration of more effective modes based on individual characteristics both of a patient, and a disease will improve the total survival of patients. This will result in reduction of economic resources spent on selecting new modes of treatment in patients with a disease recurrence and correction of possible adverse effects and hospitalization.

/pdf/clinical-economical-and-ethical-aspects-assessing-therapy-2jxugpxv.pdf

Clinical, economical and ethical aspects assessing therapy outcomes in patients with multiple myelomas of high cytogenetic risk

Additional file 2: Supplementary Fig. 2 LS mean change from baseline in EORTC QLQ-C30. a – Role functioning. b – Emotional functioning. c – Cognitive functioning. d – Social functioning. e – Nausea and vomiting up to 36 months (ITT population). 

Additional file 2 of Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial

Pf598 stem cell yield and transplantation in transplant-eligible newly diagnosed multiple myeloma patients receiving daratumumab + bortezomib/thalidomide/dexamethasone (d-vtd): phase 3 cassiopeia study

S874 efficacy of daratumumab + bortezomib/thalidomide/dexamethasone (d-vtd) in transplant-eligible newly diagnosed multiple myeloma based on minimal residual disease status: analysis of cassiopeia

Ps1377 improvement in health-related quality of life for newly diagnosed multiple myeloma transplant-eligible patients treated with daratumumab, bortezomib, thalidomide, and dexamethasone: cassiopeia study

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Pf598 stem cell yield and transplantation in transplant-eligible newly diagnosed multiple myeloma patients receiving daratumumab + bortezomib/thalidomide/dexamethasone (d-vtd): phase 3 cassiopeia study

S874 efficacy of daratumumab + bortezomib/thalidomide/dexamethasone (d-vtd) in transplant-eligible newly diagnosed multiple myeloma based on minimal residual disease status: analysis of cassiopeia

Ps1377 improvement in health-related quality of life for newly diagnosed multiple myeloma transplant-eligible patients treated with daratumumab, bortezomib, thalidomide, and dexamethasone: cassiopeia study