The US FDA has granted priority review for bortezomib [Velcade] for the treatment of patients with newly diagnosed multiple myeloma (MM).

2008 ◽  
Vol &NA; (1624) ◽  
pp. 23
Author(s):  
&NA;
2021 ◽  
Author(s):  
Sebastian Grosicki ◽  
Martyna Bednarczyk ◽  
Agnieszka Barchnicka ◽  
Olga Grosicka

Multiple myeloma (MM) is still considered an incurable disease. However, drugs with different mechanisms of action that can improve the efficiency of treatment offer hope. Still, there are concerns about an unacceptable increase in toxicity with such regimens. The results of recently published clinical studies of elotuzumab in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone confirm previous hopes to improve the effect of that treatment. Humanized monoclonal antibodies aimed at SLAMF7 stimulate natural killer cells to fight against MM cells. Elotuzumab used in combination with lenalidomide/dexamethasone or with pomalidomide/dexamethasone is approved by the US FDA to treat patients with relapsed and/or refractory MM. The article is a summary of the recent knowledge about the possibility of using elotuzumab in the treatment of relapsed and/or refractory MM and shows its potential uses in the future.


2020 ◽  
Author(s):  
Cyrille Touzeau ◽  
Chloé Antier ◽  
Philippe Moreau

The therapeutic landscape of relapsed multiple myeloma (MM) is constantly evolving. To date, a large proportion of patients present with lenalidomide refractory disease at time of first or second relapse. In this context, few efficient options are currently available. Carfilzomib and daratumumab are approved in the relapse setting. Recently, Phase Ib and Phase III trials evaluated the triplet drug combination daratumumab–carfilzomib–dexamethasone in the relapse setting and demonstrated strong clinical efficacy, especially in lenalidomide refractory patients. Based on these results, this combination has been approved by the US FDA for relapsed MM patients. The present review discusses the safety and efficacy of daratumumab–carfilzomib–dexamethasone in MM.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20014-e20014
Author(s):  
Karun Neupane ◽  
Hamid Ehsan ◽  
Ahsan Wahab ◽  
Adeel Masood ◽  
Tehniat Faraz Ahmed ◽  
...  

e20014 Background: Selinexor (Sel) and belantamab mafodotin (belamaf) were recently approved by the US FDA for treatment of relapsed/refractory multiple myeloma on July 2019 and August 2020 respectively. The toxicity profile of these drugs is a concern since these are approved for use in patients who have already undergone multiple lines of treatment. Methods: Six studies for Sel and two for belamaf were included after a systematic search of PubMed, Embase, Cochrane, and Clinicaltrials.gov. Results: The most common hematological toxicity associated with these two drugs is thrombocytopenia. The common G-3/4 hematological AEs of Sel were thrombocytopenia (39%-71%), anemia (16%-33%), leukopenia (8%-33%) and neutropenia (9%-33%) whereas common G-3/4 non-hematological AEs were hyponatremia (5%-26%), fatigue (13%-15%), diarrhea (5%-10%), eye disorders (9%-10%), musculoskeletal disorders (4%-10%), elevated liver enzymes (10%), peripheral neuropathy (5%) and vomiting (2-4%). Keratopathy and anemia were the major toxicities of belamaf. Most of these toxicities are manageable. Treatment modifications and dose interruption are usually needed when AEs are more than grade II. REMS program guidelines is recommended for close monitoring and evaluation of Sel and belamaf toxicities and early ophthalmological intervention. Conclusions: As these are newer drugs with limited data, continuous surveillance and monitoring is warranted during the treatment course with early mitigation strategies. The physician should be aware of thrombocytopenia and its management as well as belamaf ocular toxicity which is manageable but if missed could have serious complications.[Table: see text]


2021 ◽  
Author(s):  
Lucio N Gordan ◽  
Stanley M Marks ◽  
Mei Xue ◽  
Neil Nagovski ◽  
J Hunter Lambert ◽  
...  

Background: The introduction of daratumumab into the treatment of multiple myeloma has improved outcomes in patients; however, community oncologists often dose more frequently than the US FDA-approved label. Materials and methods: Integra analyzed its database to elucidate daratumumab treatment patterns and the impact of increased utilization on the cost of care for multiple myeloma. Results: Following week 24, 671 (65%) of 1037 patients remained on daratumumab-containing regimens, with 330 patients continuing more frequent treatments than the expected once-every-4-weeks dosing described in the standard dosing schedule. Patients received an average of 14% more daratumumab doses than the FDA-approved label indicates, increasing the 1-year daratumumab costs by an estimated US$31,353. Conclusion: Daratumumab is utilized more frequently than the FDA-recommended dosing, leading to higher multiple myeloma treatment costs.


2021 ◽  
Author(s):  
Larry D Anderson

Idecabtagene vicleucel (ide-cel), a novel chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA), has recently gained approval by the US FDA for relapsed and refractory multiple myeloma (RRMM) after multicenter trials have demonstrated unprecedented results in this difficult-to-treat subgroup of patients. As the first CAR T-cell product approved for myeloma, ide-cel is poised to become a practice-changing treatment option. This first-in-class therapeutic offers hope for more durable remissions, as well as better quality of life, following a single infusion in a group of patients that previously had little hope. This paper reviews the ide-cel product in terms of design, pharmacology, efficacy and toxicity as described in studies reported to date.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2916-2916 ◽  
Author(s):  
Kristin D Kistler ◽  
Kanya Rajangam ◽  
Gerald Faich ◽  
Stephan Lanes

Abstract Abstract 2916 Background: Factors contributing to cardiac comorbidity in patients, typically elderly, with multiple myeloma (MM) include age-related cardiac risks as well as disease related factors such as amyloid infiltration, hyperviscosity, A-V shunting and chronic anemia (McBride, 1988; Robin, 2008; Inanir, 1998). Cardiac effects, associated with anthracycline therapy and transplant, have been reported with alkylating agents (myopericarditis, acute cardiomyopathy), immunomodulatory drugs (IMiDs) (arrhythmias, myocardial infarction) and proteasome inhibitors (congestive heart failure [CHF]) (Kyle, 2003; Chow, 2011; Revlimid PI 2012; Velcade PI 2012; Singhal S, 2011). Estimating the frequency of cardiac adverse events (AEs) in MM patients would help in understanding the magnitude of these risks and would provide context for rates of observed AEs. To our knowledge, this is the first analysis to examine the incidence and prevalence of cardiac AEs in patients with MM. Methods: We conducted a retrospective cohort study in the US using the MarketScan® commercial and Medicare supplemental insurance claims database from January 1, 2006 to December 31, 2011. Adult patients were included with a MM diagnosis following 6 months of continuous enrollment (baseline period) and no gaps in insurance coverage >31 days. Newly diagnosed MM patients were analyzed separately from patients with relapsed MM, defined as patients previously treated with ≥3 regimens (bortezomib, IMiDs, and alkylating agents or anthracyclines). Study entry date for newly diagnosed patients was the MM diagnosis date and, for the relapsed patients, the date patients' met the criteria of having received ≥3 regimens. Diagnosis, procedure and treatment codes (ICD-9, HCPCS, and NDC) were used to classify patients. The study period was defined as the duration from study entry date to study end (i.e., December 31, 2011 or the end of continuous enrollment or prescription drug coverage). Cardiac AEs were captured separately for inpatient, outpatient, and any site of care, and included any cardiac event, CHF, ischemic heart disease (IHD), and arrhythmias. Cardiac events present during baseline were identified as comorbidities. Results: N=32,193 patients met inclusion criteria, the majority were newly diagnosed. The mean time on study ranged from 12 to 18 months (max 5 yrs). The mean age was 63 yrs, and approximately 50% of subjects were male. Cardiac comorbidities were common; nearly two-thirds of patients had baseline cardiac events, of which arrhythmias and IHD were most frequent. While on study, the incidence of any cardiac AE was 72% for newly diagnosed and 71% for relapsed patients. The most common cardiac events during the study period were arrhythmias, IHD, and CHF. In general, event rates were similar between newly diagnosed and relapsed patients (Table 1). Conclusions: This retrospective study provides the first estimates of cardiac AE rates in a large population of MM patients, both newly diagnosed and relapsed, in a clinical practice setting in the US. During the study period, regardless of treatment stage of disease, nearly three quarters of MM patients experienced a cardiac AE. These results demonstrate a high prevalence of cardiac comorbidities and occurrence of cardiac events in MM patients, especially arrhythmias and heart failure, regardless of relapse status and type of anti-MM treatment. Disclosures: Kistler: Onyx: Consultancy, Research Funding. Rajangam:Onyx: Employment. Faich:Onyx: Consultancy, Research Funding. Lanes:Onyx: Consultancy, Research Funding.


Sign in / Sign up

Export Citation Format

Share Document