Trial Outcomes & Findings for COVID19 OutcomeS in Myeloma and the Impact of VaCcines (NCT NCT05831787)
NCT ID: NCT05831787
Last Updated: 2026-05-18
Results Overview
Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
COMPLETED
201 participants
At Baseline
2026-05-18
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Baseline
STARTED
|
201
|
|
Baseline
COMPLETED
|
196
|
|
Baseline
NOT COMPLETED
|
5
|
|
Month 1
STARTED
|
196
|
|
Month 1
COMPLETED
|
162
|
|
Month 1
NOT COMPLETED
|
34
|
|
Month 6
STARTED
|
162
|
|
Month 6
COMPLETED
|
159
|
|
Month 6
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID19 OutcomeS in Myeloma and the Impact of VaCcines
Baseline characteristics by cohort
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
120 Participants
n=11 Participants
|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 10.21 • n=11 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic, White
|
143 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic, Black
|
34 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latina/Latino
|
15 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
4 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
196 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: At BaselineProportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=200 Participants
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.
|
|---|---|
|
Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients.
|
196 Participants
|
PRIMARY outcome
Timeframe: 30 days after enrollmentPopulation: 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
Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=200 Participants
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.
|
|---|---|
|
Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients.
|
162 Participants
|
PRIMARY outcome
Timeframe: 6 months after enrollmentPopulation: 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
proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=200 Participants
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.
|
|---|---|
|
Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients.
|
159 Participants
|
SECONDARY outcome
Timeframe: At BaselinePopulation: 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.
Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
COVID Vaccine Prevalence
|
186 Participants
|
SECONDARY outcome
Timeframe: 30 Days after enrollmentPopulation: 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.
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
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
COVID Booster Incidence
|
18 Participants
|
SECONDARY outcome
Timeframe: During 6 month study periodPopulation: 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.
Among participants providing PROs, percentage for whom PROs were viewed by site personnel
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
PRO Review
|
196 Participants
|
SECONDARY outcome
Timeframe: At BaselinePopulation: 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.
Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
COVID-19 Infection Baseline
|
111 Participants
|
SECONDARY outcome
Timeframe: During 6 month study periodPopulation: 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.
Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
COVID-19 Infection on Study
|
18 Participants
|
SECONDARY outcome
Timeframe: At BaselinePopulation: 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.
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).
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
Patient Reported COVID 19 Related Outcomes at Baseline
|
0 Participants
|
SECONDARY outcome
Timeframe: During 6 month study periodPopulation: 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.
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).
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
Patient Reported COVID 19 Related Outcomes on Study
|
0 Participants
|
SECONDARY outcome
Timeframe: At BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=79 Participants
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.
|
|---|---|
|
EHR COVID 19 Related Outcomes Baseline
|
0 Participants
|
SECONDARY outcome
Timeframe: During 6 month study periodPopulation: 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.
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.
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=79 Participants
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.
|
|---|---|
|
EHR COVID 19 Related Outcomes on Study
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 months after enrollmentPopulation: 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.
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
Outcome measures
| Measure |
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
n=196 Participants
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.
|
|---|---|
|
COVID Booster Incidence
|
39 Participants
|
Adverse Events
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place