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| Name | Class |
|---|---|
| ModernaTX, Inc. | INDUSTRY |
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The COVID-19 pandemic has had an outsized impact on individuals with underlying social and medical vulnerability, leading to increased rates of severe disease, hospitalization, and death in these groups. Participants with underlying immune compromise, such as those with multiple myeloma, represent one such group. The advent of vaccines against SARS-CoV-2 has significantly limited morbidity and mortality across all groups, but the effectiveness of vaccination in individuals who are less likely to mount sufficient antibody response is uncertain. For this reason, booster vaccines have been recommended for those with underlying immune compromise. However, several key gaps remain in our understanding of how to best protect these individuals.
There is a dearth of real-world evidence about the effectiveness of vaccination and boosters in patients who are immunocompromised, and very little information specifically about the recently approved mRNA boosters. Additionally, rates of vaccination and booster uptake in the United States remain low. A rapid, decentralized method of ascertaining information related to booster vaccine response and adverse events related to vaccines and COVID-19 infection is critical not only to answer questions about the booster vaccines, but to develop an infrastructure for answering similar questions about future vaccines or other diseases.
The purpose of this project is to implement and establish the feasibility of a decentralized real-world evidence study network for patients with multiple myeloma and to monitor outcomes related to COVID-19 infection in this immunosuppressed population. Subjects with multiple myeloma will be invited to participate. The electronic portal will handle all consenting activities. Participants will be asked to complete specific study procedures electronically, including permission for electronic health record (EHR) data transfer. Participants will be asked to complete electronic questionnaires periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease | Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Reported Outcomes | Other | Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients. | Proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR. | At Baseline |
| Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients. | Proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR. | 30 days after enrollment |
| Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients. | proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR. | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| COVID Vaccine Prevalence | Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster | At Baseline |
| COVID Booster Incidence | Percent of patients who enroll on the study platform who went on to receive a SARS-CoV-2 booster at 1 month follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with a diagnosis of multiple myeloma per the International Myeloma Working Group and currently receiving active treatment for any phase of the disease, including initial therapy, maintenance, or relapsed disease.
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| Name | Affiliation | Role |
|---|---|---|
| William Wood, MD, MPH | UNC-Chapel Hill | Principal Investigator |
| Saad Usmani, MD,MBA,FACP | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States | ||
| UNC-Chapel Hill |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41734388 | Derived | Wood WA, Kumar SK, Semmel EA, James S, Schroeder MA, Chung DJ, Rosenberg A, Zonder J, Rubinstein S, D'Souza A, Martin T, Chari A, Vij R, Nooka AK, Anderson KC, Neuberg DS, Richard S, Torres K, Weiss BM, Pederson L, Derkach A, Geyer S, Usmani SZ. Feasibility of decentralized real-world monitoring of SARS-CoV-2 booster vaccines and COVID-19 outcomes in myeloma. Blood Adv. 2026 May 12;10(9):3094-3102. doi: 10.1182/bloodadvances.2025018963. | |
| 40396505 |
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There is no plan at this time. All study data will be stored in the ASH RC Data Hub.
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The enrollment goal was 200 patients; however, an additional patient electronically consented after the enrollment goal was met prior to the study platform being deactivated. The additional patient did not complete any study activities, and the IRB was notified.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease | Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria. Patient Reported Outcomes: Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Month 1 |
| |||||||||||||
| Month 6 |
|
This is an observational, single cohort study. Baseline measures (including Region of Enrollment) are reported for participants who completed the baseline questionnaire and provided the relevant baseline information. Participants who consented but did not complete baseline questionnaires (and therefore had missing baseline data) are not included in this baseline measure; accordingly, the Number of Participants Analyzed may be lower than the total number consented/enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease | Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria. Patient Reported Outcomes: Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients. | Proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR. | Posted | Count of Participants | Participants | At Baseline |
|
|
Per protocol, in this observational study, adverse events were not monitored or assessed; therefore, there are no adverse event results to report over the 6 month study timeframe.
Per protocol, adverse events were not prospectively or systematically collected or monitored/assessed as part of this decentralized observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease | Diagnosis of multiple myeloma must meet the International Myeloma Working Group criteria. Patient Reported Outcomes: Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys. |
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We acknowledge several limitations. We did not enroll consecutive patients or assess representativeness, limiting generalizability. Lack of Spanish materials and reliance on a patient portal requiring internet and digital literacy may contribute to disparities. PRO data use in decision-making was not studied. COVID-19 status was mainly self-reported, so misclassification is possible
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Semmel, Deputy Director ASH RC Data Hub | ASH RC | 202-552-4902 | esemmel@ashrc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2023 | Feb 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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| 30 Days after enrollment |
| PRO Review | Among participants providing PROs, percentage for whom PROs were viewed by site personnel | During 6 month study period |
| COVID-19 Infection Baseline | Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing | At Baseline |
| COVID-19 Infection on Study | Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing | During 6 month study period |
| Patient Reported COVID 19 Related Outcomes at Baseline | Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization). | At Baseline |
| Patient Reported COVID 19 Related Outcomes on Study | Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization). | During 6 month study period |
| EHR COVID 19 Related Outcomes Baseline | Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR. | At Baseline |
| EHR COVID 19 Related Outcomes on Study | Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR. | During 6 month study period |
| COVID Booster Incidence | Percent of patients who enrolled on the study platform and subsequently received a SARS-CoV-2 booster by the 6-month follow-up visit. Booster vaccination status was assessed using a combination of patient-reported data collected through the study platform and available electronic health record (EHR) data | 6 months after enrollment |
| Chapel Hill |
| North Carolina |
| 27514 |
| United States |
| Derived |
| Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients. | Proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR. | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures | Posted | Count of Participants | Participants | 30 days after enrollment |
|
|
|
| Primary | Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients. | proportion of consented participants who provide responses for the PRO instruments & proportion of participants who permission access to clinical data through the EHR. | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures | Posted | Count of Participants | Participants | 6 months after enrollment |
|
|
|
| Secondary | COVID Vaccine Prevalence | Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures. Four additional patients either withdrew or did not provide a response for this data variable. | Posted | Count of Participants | Participants | At Baseline |
|
|
|
| Secondary | COVID Booster Incidence | Percent of patients who enroll on the study platform who went on to receive a SARS-CoV-2 booster at 1 month follow up visit | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures. Four additional patients either withdrew or did not provide a response for this data variable. | Posted | Count of Participants | Participants | 30 Days after enrollment |
|
|
|
| Secondary | PRO Review | Among participants providing PROs, percentage for whom PROs were viewed by site personnel | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures. Four additional patients either withdrew or did not provide a response for this data variable. | Posted | Count of Participants | Participants | During 6 month study period |
|
|
|
| Secondary | COVID-19 Infection Baseline | Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures. Four additional patients either withdrew or did not provide a response for this data variable. | Posted | Count of Participants | Participants | At Baseline |
|
|
|
| Secondary | COVID-19 Infection on Study | Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures. Four additional patients either withdrew or did not provide a response for this data variable. | Posted | Count of Participants | Participants | During 6 month study period |
|
|
|
| Secondary | Patient Reported COVID 19 Related Outcomes at Baseline | Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization). | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures. Four additional patients either withdrew or did not provide a response for this data variable. | Posted | Count of Participants | Participants | At Baseline |
|
|
|
| Secondary | Patient Reported COVID 19 Related Outcomes on Study | Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization). | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures. Four additional patients either withdrew or did not provide a response for this data variable. | Posted | Count of Participants | Participants | During 6 month study period |
|
|
|
| Secondary | EHR COVID 19 Related Outcomes Baseline | Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR. | Among the enrolled participants, 79 consented to share their electronic health record (EHR) data. Participation in EHR data sharing was optional and not a requirement of the study. | Posted | Count of Participants | Participants | At Baseline |
|
|
|
| Secondary | EHR COVID 19 Related Outcomes on Study | Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR. | Among the enrolled participants, 79 consented to share their electronic health record (EHR) data. Participation in EHR data sharing was optional and not a requirement of the study. | Posted | Count of Participants | Participants | During 6 month study period |
|
|
|
| Secondary | COVID Booster Incidence | Percent of patients who enrolled on the study platform and subsequently received a SARS-CoV-2 booster by the 6-month follow-up visit. Booster vaccination status was assessed using a combination of patient-reported data collected through the study platform and available electronic health record (EHR) data | The total enrollment for the study was 201 patients. Although the initial enrollment goal was 200 patients, an additional participant consented before the study was closed to enrollment. However, this participant did not complete any study procedures. Four additional patients either withdrew or did not provide a response for this data variable. | Posted | Count of Participants | Participants | 6 months after enrollment |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 |
| Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |