COVID‐19 and myeloma clinical research – experience from the CARDAMON clinical trial

Camilleri, Marquita; Sive, Jonathan; Wilson, William T.; Pang, Gavin; Jenner, Richard; Phillips, Elizabeth H; Popat, Rakesh; Ramasamy, Karthik; Bygrave, Ceri; Dadaga, Tushhar; Streetly, Matthew; Cavenagh, James D.; Chapman, Mike; Barrington, Sally F.; Pike, Lucy; Owen, Roger G.; Clifton‐Hadley, Laura; Yong, Kwee

doi:10.1111/bjh.17168

Cited by 7 publications

(4 citation statements)

References 5 publications

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“… 41 A phase II myeloma RCT found that data collection via telephone and/or video conferencing was valid and complete, with in-person assessments done as needed. 42 In addition, in a RCT assessing the impact of teleintervention on the mental health of adults with type 2 diabetes, telehealth visits helped patients and health professionals maintain relationships and reduced the incidence of diabetes-related emotional distress. 43 Telehealth practices vary across subgroups, however, and may require tailoring.…”

Section: Discussionmentioning

confidence: 99%

Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials

Salovaara

Nicholson

et al. 2022

Clinical Trials

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Background/Aims: High follow-up is critical in randomized clinical trials. We developed novel approaches to modify in-person visits and complete follow-up during COVID-19. Since these strategies are broadly applicable to circumstances wherein follow-up is difficult, they may help in contingency planning. The objective of this article is to develop and evaluate new approaches to replace detailed, in-person study visits for two trials focused on preventing diabetic foot complications. Methods: A quasi-experimental pre–post design compared approaches for follow-up during COVID-19 to approaches pre-COVID-19. Study subjects were outpatients at two Veterans Affairs Medical Centers. Following a research “hold,” research resumed in February 2021 for Self-monitoring, Thermometry and Educating Patients for Ulcer Prevention (STEP UP) (n = 241), which focused on preventing recurrent foot ulcers, and in April 2021 for Preventing Amputation by Tailored Risk-based Intervention to Optimize Therapy (PATRIOT) (n = 406), which focused on preventing pre-ulcerative and ulcerative lesions. To complete data collection, we shortened visits, focused on primary and secondary outcomes, and conducted virtual visits when appropriate. For STEP UP, we created a 20-min assessment process that could be administered by phone. Since PATRIOT required plantar photographs to assess foot lesions, we conducted short face-to-face visits. We explored differences and assessed proportion completing visit, visit completion/100 person-months and compared COVID-19 to pre- COVID-19 using unadjusted risk ratios, incidence rate ratios, all with associated 95% confidence intervals (CIs). Finally, we report time-to-visit curves. Results: In both studies, participants whose follow-up concluded pre- COVID-19 seemed older than those whose follow-up concluded during COVID-19 (PATRIOT: 68.0 (67.2, 68.9) versus 65.2 years (61.9, 68.5); STEP UP: 67.5 (66.2, 68.9) versus 65.3 (63.3, 67.3)). For STEP UP, we completed 91 visits pre- COVID-19 (37.8% (31.6%, 44.2%)) and 63 visits during COVID-19 (78.8% (68.2%, 87.1%)). This was over 1309 person-months pre-COVID-19, and over 208.8 person-months during COVID-19; the visit completion rate/100 person-months were: pre-COVID-19 7.0 (5.6, 8.5), COVID-19 30.2 (23.2, 38.6); risk ratio: 2.1 (1.7, 2.5); and incidence rate ratio 4.3 (3.1, 5.9). Similarly, for PATRIOT, we completed 316 visits pre-COVID-19 (77.8% (73.5%, 81.8%)) and 27 assessments during COVID-19 (84.4% (67.2%, 94.7%)). This was over 1192.7 person-months pre-COVID-19 and 39.3 person-months during COVID-19. The visit completion rate/100 person-months in PATRIOT were: pre-COVID-19 2.7 (2.4, 3.0), COVID-19 6.9 (4.5, 10); risk ratio 1.1 (0.9, 1.3); incidence rate ratio 2.6 (1.8, 3.8). For both studies, the follow-up curves began separating at < 2 months. Conclusions: We achieved higher completion rates during COVID-19 compared to pre-COVID-19 by modifying visits and focusing on primary and secondary outcomes. These strategies prevent excessive missing data, support more valid conclusions, and improve efficiency. They may provide important alternative strategies to achieving higher follow-up in randomized clinical trials.

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Section: Discussionmentioning

confidence: 99%

Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials

Salovaara

Nicholson

et al. 2022

Clinical Trials

View full text Add to dashboard Cite

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“…The COVID-19 pandemic has also caused an unprecedented disruption throughout the cancer research community and has slowed down cancer clinical trial operations [ 19 , 20 ]. Once normal service resumes at a population and health-service level, there will be a huge backlog of patients with potential cancer symptoms needing urgent assessment [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

COVID-19 Virus Infection in Three Patients With Hypogammaglobulinemia

Gesiotto¹,

Cheema²,

Avaiya³

et al. 2021

Cureus

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The world is experiencing the COVID-19 outbreak and there are no evidence-based treatment strategies available for immunocompromised patients. COVID-19 is a novel beta coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients with cancer are more susceptible to infection than individuals without cancer due to their impaired humoral and cellular immune function caused by the malignancy itself and chemotherapy. We present three cases of cancer patients with hypogammaglobulinemia with varying clinical outcomes associated with infection. These include one mantle cell lymphoma patient with recurrent respiratory infection requiring intravenous immunoglobulin (IVIG) support and two multiple myeloma patients with continued viral shedding.

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“…During the COVID-19 pandemic, after March 25, 2020, delays were permitted up to 14 weeks and when more than 12 months of maintenance had been completed, treatment could stop at the discretion of the investigator. 16 After cases of thrombotic microangiopathy were reported, the protocol was amended to include a step-up carfilzomib dose at the reduced amount of 20 mg/m² for any patient resuming treatment after a break of more than 4 weeks, before returning to the protocol dose of 56 mg/m² (or the last dose amount administered after any reduction).…”

Section: Methodsmentioning

confidence: 99%

Upfront autologous haematopoietic stem-cell transplantation versus carfilzomib–cyclophosphamide–dexamethasone consolidation with carfilzomib maintenance in patients with newly diagnosed multiple myeloma in England and Wales (CARDAMON): a randomised, phase 2, non-inferiority trial

Yong

Wilson²,

Tute³

et al. 2023

The Lancet Haematology

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COVID‐19 and myeloma clinical research – experience from the CARDAMON clinical trial

Cited by 7 publications

References 5 publications

Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials

Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials

COVID-19 Virus Infection in Three Patients With Hypogammaglobulinemia

Upfront autologous haematopoietic stem-cell transplantation versus carfilzomib–cyclophosphamide–dexamethasone consolidation with carfilzomib maintenance in patients with newly diagnosed multiple myeloma in England and Wales (CARDAMON): a randomised, phase 2, non-inferiority trial

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