Mansi R. Shah, MD, highlights the data on the effects of IVIG on infections in patients with relapsed/refractory multiple myeloma treated with teclistamab. 

Dr Shah on the Effect of IVIG on Infection Risk in R/R Multiple Myeloma

“When we looked overall, the risk of developing infections was significantly lower in the IVIG group with primary prophylaxis, particularly bacterial infections, but it didn't really have as much of an impact on viral infections.”

Mansi R. Shah, MD, assistant professor, medicine, Division of Blood Disorders, Rutgers Cancer Institute of New Jersey, Robert Wood Johnson (RWJ) Medical School; hematologist/oncologist, RWJ University Hospital, highlights the data on the effects of intravenous immunoglobulin (IVIG) supplementation on infections in patients with relapsed/refractory multiple myeloma treated with teclistamab-cqyv (Tecvayli). These data were presented at the 

The study included patients with relapsed/refractory multiple myeloma (n = 168) who received primary prophylaxis and secondary prophylaxis, Shah explains. The risk of bacterial infections was shown to be significantly lower in patients treated with primary prophylaxis, she notes.

Of note, the most common dosing schedule for IVIG was 0.4 mg/kg every 4 weeks. There were 181 recorded infections among 92 patients. Infections included 53% that were bacterial in 61 patients, 42% were viral in 52 patients, and 9 fungal infections were observed in 7 patients. Of these infections, 55% were grade 3 or greater, with 57% of these infections requiring inpatient hospitalization. The 3-month cumulative incidence of all-grade infection was 43% (95% CI, 36%-52%), and the rate of grade 3 or greater infection was 23% (95% CI, 15%-92%). Regarding those who were not given IVIG, the 3-month cumulative incidence of all-grade infection was 49% (95% CI, 39%-61%). In patients on primary and secondary IVIG, the 3-month cumulative incidence of all-grade infection was 36% (95% CI, 26%-50%) and 38% (95% CI, 15%-92%).

In patients treated with secondary prophylaxis who received IVIG after developing an infection, the IVIG did not make a significant impact on viral infections, she says. In patients from the secondary group, she concludes that IVIG had an impact on bacterial infections but not other infections.

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Dr Shah on the Effects of IVIG on Teclistamab-Associated Infection Risk in Myeloma

“When we looked overall, the risk of developing infections was significantly lower in the IVIG group with the primary prophylaxis, particularly bacterial infections.”

Mansi R. Shah, MD, assistant professor, medicine, Division of Blood Disorders, Rutgers Cancer Institute of New Jersey, Robert Wood Johnson (RWJ) Medical School; hematologist/oncologist, RWJ University Hospital, discusses a multi-institutional study of the effects of intravenous immunoglobulin (IVIG) supplementation on infection risk in recipients of teclistamab-cqyv (Tecvayli) therapy for multiple myeloma.

This study focused on patients with relapsed/refractory multiple myeloma receiving BCMA-targeted bispecific antibodies, Shah begins. The analysis was unique as it included patients enrolled in early-phase clinical trials of these therapies, allowing investigators to evaluate infection risks across different patient cohorts, according to Shah. Conducted as a retrospective study across 4 institutions, the data provided insights into infection prevention strategies in this heavily pretreated population, she reported.

The patient cohort had a median age of approximately 70 years, with over half of the participants being older than 70 years, Shah continues. On average, patients had undergone 5 prior lines of therapy (range, 2-12), and nearly all had received prior autologous stem cell transplant. The study assessed the effect of IVIG as either primary or secondary prophylaxis against infections, she explains. Primary prophylaxis was defined as IVIG administration within 60 days of BCMA-directed bispecific antibody initiation, whereas secondary prophylaxis was IVIG given after an infection had developed, Shah states. The findings revealed that patients who received primary prophylaxis had a significantly reduced risk of bacterial infections vs those who received secondary prophylaxis, with a hazard ratio of approximately 0.6. Conversely, secondary prophylaxis had a more limited effect on reducing infection risk, she emphasizes.

Secondary prophylaxis also demonstrated some benefit against the development of bacterial infections but did not influence the risk of developing other types of infections. These differences in infection prevention strategies were associated with improved overall survival and progression-free survival in patients receiving BCMA-targeted therapies, she says. However, infections remain a significant factor that could limit both treatment efficacy and dosing in this population, Shah concludes.

Mansi R. Shah, MD, on the effects of IVIG on infections in recipients of teclistamab therapy for multiple myeloma.

Mansi R. Shah, MD, hematologist/oncologist, Rutgers Cancer Institute of New Jersey, assistant professor of medicine, Rutgers Robert Wood Johnson Medical School and attending at Robert Wood Johnson University Hospital, discusses ongoing research examining the CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma.

At the Rutgers Cancer Institute of New Jersey, many clinical trials are available to patients with relapsed or refractory disease, including a study examining cilta-cel, according to Shah. Currently, idecabtagene vicleucel (ide-cel; Abecma) is the only CAR T-cell therapy that is FDA approved for this patient population and wait lists to receive this product are long because the demand for this treatment has outweighed the supply, Shah says.

Cilta-cel is available to patients in a clinical trial setting for use in different lines of therapy, Shah adds. The trial that is being done at the instate provides patients with the opportunity to receive treatment with the novel modality, Shah concludes.

Mansi R. Shah, MD, discusses ongoing research examining the CAR T-cell therapy ciltacabtagene autoleucel for the treatment of patients with relapsed or refractory multiple myeloma.

Dr. Shah on Trials Examining Cilta-Cel in Relapsed/Refractory Multiple Myeloma 

Patients with hematologic malignancies, which include cancers that affect the blood, bone marrow, and lymph nodes, have demonstrated a higher susceptibility to COVID-19 potentially because of inherent and cancer therapy–related immunosuppression

Current evidence suggests that COVID-19–related morbidity and mortality is higher in patients with underlying co-morbidities, male gender, older age, and immunosuppression.

 The initial fatality rates reported for patients with cancer who harbored a SARS-CoV-2 infection ranged from 28% in China

With the onset of the unprecedented COVID-19 pandemic, cancer care provision was upended as resource-limited oncology care systems balanced reduction of SARS-CoV-2 exposure with the prioritization of timely cancer diagnostics and treatments. Consensus guidelines that prioritized infection control and re-organization of care were quickly established to limit the negative impact of the pandemic on patients with cancer

 whose management involves multiple visits to healthcare facilities for doctor visits, bloodwork, imaging, social work, financial consultations, therapy administration, etc.

Due to the concern of contracting SARS-CoV-2, cancer screening has decreased

 and significantly postponed the identification of new cancer

 with an estimated increased resultant mortality.

 Compared with the pre-pandemic era, dramatic reductions are observed in the demand for cancer services; this has still not fully recovered. Although COVID-19 is transmitted from person to person through respiratory droplets,

 under laboratory experimental conditions, SARS-CoV-2 was shown to be viable for up to 72 hours; this may be a possible vector of infection for vulnerable patients with cancer.

There is a potential risk of SARS-CoV-2 spreading via contact with contaminated surfaces and equipment—especially in healthcare settings, creating additional concern for patients with blood cancers.

However, the viability of the virus may differ in real-world clinical environments, promoting the strict use of personal protective equipment (PPE), social distancing, hand hygiene and disinfectant protocols.

 Previously, no studies evaluating SARS-CoV-2 surface contamination in the outpatient or inpatient Hematology and Medical Oncology settings had been published. Thus, in this prospective study, we evaluated the frequency of SARS-CoV-2 on various environmental surfaces in outpatient and inpatient hematology/oncology settings within Rutgers Cancer Institute of New Jersey and Robert Wood Johnson University Hospital, an RWJBarnabas Health facility.

Environmental sampling was done in high-touch areas in 2 outpatient clinic settings including malignant hematology and medical oncology infusion suites, as well as inpatient areas, which included the leukemia/lymphoma/CAR T-cell unit, and an inpatient unit caring for patients actively infected with COVID-19. Surfaces were sampled on Mondays, Wednesdays, and Fridays from June 17, 2020, through June 29, 2020. Areas included waiting rooms, infusion areas, bathrooms, floors, elevator banks, doors, exam rooms, computer equipment, pneumatic tubing stations, pharmacy areas, and nursing stations. Medical equipment such as intravenous poles, chemotherapy bags, vitals monitor, telemetry stations, and linen carts, in these areas were also swabbed.

A total of 204 samples were collected and characterized as: patient/public areas, staff areas, and medical equipment. In the 2 outpatient clinics and inpatient leukemia/lymphoma/CAR T-cell unit, no SARS-CoV-2 was detected on any swabbed surfaces (0 out of 130). In the inpatient COVID unit, 1 patient/public sample was positive for detection of SARS-CoV-2 in an area where a patient with recent COVID-19 infection was receiving treatment. The overall positive test rate for SARS-CoV-2 across all surfaces in the combined outpatient and inpatient hematology/oncology units was a low 0.5%.

The study revealed extremely low detection of SARS-CoV-2 on environmental surfaces across multiple outpatient and inpatient oncology areas, including an active COVID-19 floor. These data should provide reassurance and highlight the adequacy of established infection prevention and control policies, such as increased use of telemedicine, nursing-directed triage, isolation protocols, and the importance of appropriate personal protective equipment (PPE), social distancing, and disinfection protocols.

Collectively, the results of this study should alleviate concerns of infection transmission for healthcare providers and patients—especially those with blood cancers—when frequenting healthcare facilities to receive their care. We hope to reclaim cancer care when equipped with an improved understanding of SARS-CoV-2 viral transmission dynamics, ongoing infection prevention measures, and accelerated rates of COVID-19 rates of vaccination—especially for patients with cancer.

Dai M, Liu D, Liu M, et al. Patients with cancer appear more vulnerable to SARS-CoV-2: a multicenter dtudy during the COVID-19 outbreak. 

 2020;10(6):783-791. doi:10.1158/2159-8290.CD-20-0422

Liang W, Guan W, Chen R, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. 

 2020;21(3):335-337. doi:10.1016/S1470-2045(20)30096-6

Lee LY, Cazier J-B, Angelis V, et al. COVID-19 mortality in patients with cancer on chemotherapy or other anticancer treatments: a prospective cohort study. 

 2020;395(10241):1919-1926. doi:10.1016/S0140-6736(20)31173-9

Kuderer NM, Choueiri TK, Shah DP, et al. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. 

 2020;395(10241):1907-1918. doi:10.1016/S0140-6736(20)31187-9

Al-Shamsi HO, Alhazzani W, Alhuraiji A, et al. A practical approach to the management of cancer patients during the novel coronavirus disease 2019 (COVID-19) pandemic: an International Collaborative Group. 

 2020;25(6):e936-e945. doi:10.1634/theoncologist.2020-0213

Curigliano G, Banerjee S, Cervantes A, et al. Managing cancer patients during the COVID-19 pandemic: an ESMO multidisciplinary expert consensus. 

 2020;31(10):1320-1335. doi:10.1016/j.annonc.2020.07.010

Patt D, Gordan L, Diaz M, et al. Impact of COVID-19 on cancer care: how the pandemic Is delaying cancer diagnosis and treatment for American seniors. 

 2020(4):1059-1071. doi:10.1200/CCI.20.00134

Kaufman HW, Chen Z, Niles J, et al. Changes in the number of US patients with newly identified cancer before and during the coronavirus disease 2019 (COVID-19) pandemic. 

 2020;3(8):e2017267. doi:10.1001/jamanetworkopen.2020.17267

Lai AG, Pasea L, Banerjee A, et al. Estimated impact of the COVID-19 pandemic on cancer services and excess 1-year mortality in people with cancer and multimorbidity: near real-time data on cancer care, cancer deaths and a population-based cohort study. 

 2020;10(11):e043828. doi:10.1136/bmjopen-2020-043828

Zou L, Ruan F, Huang M, et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. 

 2020;382(12):1177-1179. doi:10.1056/NEJMc2001737

Van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and surface stability of SARS-CoV-2 as compared with SARS-CoV-1. 

 2020;382(16):1564-1567. doi:10.1056/NEJMc2004973

Chu DK, Akl EA, Duda S, Solo K, et al. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. 

 2020;395(10242):1973-1987. doi:10.1016/S0140-6736(20)31142-9

Shah MR, Jan I, Johns J, et al. SARS-CoV-2 nosocomial infection: Real-world results of environmental surface testing from a large tertiary cancer center. 

 2021;127(11):1926-1932. doi:10.1002/cncr.33453

Mansi R. Shah, MD, is a hematologist/oncologist and assistant professor of medicine in the Division of Blood Disorders at Rutgers Cancer Institute of New Jersey and Robert Wood Johnson Medical School.

Articles

Patients with hematologic malignancies, which include cancers that affect the blood, bone marrow, and lymph nodes, have demonstrated a higher susceptibility to COVID-19 potentially because of inherent and cancer therapy–related immunosuppression.

Mansi R. Shah, MD

Articles

Dr Shah on the Effect of IVIG on Infection Risk in R/R Multiple Myeloma

Dr Shah on the Effects of IVIG on Teclistamab-Associated Infection Risk in Myeloma

Dr. Shah on Trials Examining Cilta-Cel in Relapsed/Refractory Multiple Myeloma

SARS-CoV2 Data: Real‐World Results of Environmental Surface Testing From a Large Tertiary Cancer Center