Multiple MyelomaCOSMICNCT05831787

COVID19 OutcomeS in Myeloma and the Impact of VaCcines

An observational study of Multiple Myeloma, run by ASH Research Collaborative at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Multiple Myeloma
What is being tested?: Patient Reported Outcomes
How many people: 201 participants
Where: 2 sitesUnited States
Study dates: 23 Jan 2024to 31 Dec 2024
How long will I take part?: 6 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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.

Who may be able to join

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.
Access to the internet
An active patient portal (or willingness to activate)
Willing to electronically sign the study-specific informed consent and authorization form

Who cannot join

Non-English speaking
Lack of internet access
Cognitive impairment precluding ability to provide informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UNC-Chapel Hill
Chapel Hill, North Carolina, 27514
Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Other trials in United States

About this study

Official title: Monitoring SARS-CoV-2 Vaccines and COVID-19 Related Outcomes in Individuals With Multiple Myeloma

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.

Read the detailed description

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.

Conditions: Multiple Myeloma
Being tested: Patient Reported Outcomes
Keywords: Myeloma, COVID-19, Vaccine, COSMIC
Medical subject headings: Multiple Myeloma, Neoplasms, Plasma Cell, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient Reported OutcomesOther
Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.

Study groups in NCT05831787
Study group	Role	What they receive
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. Receives: Other: Patient Reported Outcomes

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 6 months after enrollment

Secondary outcomes (10)

COVID Vaccine Prevalence
Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster
Measured: 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
Measured: 30 Days after enrollment
PRO Review
Among participants providing PROs, percentage for whom PROs were viewed by site personnel
Measured: During 6 month study period
COVID-19 Infection Baseline
Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
Measured: At Baseline
COVID-19 Infection on Study
Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 202431 Dec 2024

First posted26 Apr 2023
Study start23 Jan 2024
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 201 participants (actual)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05831787
Sponsor's protocol ID: ASH RC DH 2022-00001
Acronym: COSMIC
Status last verified: Apr 2026
First submitted: 20 Apr 2023
Last updated: 18 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: There is no plan at this time. All study data will be stored in the ASH RC Data Hub.

Publications

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.
PubMed 41734388
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.
PubMed 40396505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Monitoring SARS-CoV-2 Vaccines and COVID-19 Related Outcomes in Individuals With Multiple Myeloma
ClinicalTrials.gov ID: NCT05831787
Acronym / sponsor ID: COSMIC / ASH RC DH 2022-00001
Conditions: Multiple Myeloma
Keywords: Myeloma, COVID-19, Vaccine, COSMIC
Study type: Observational
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: ASH Research CollaborativeUniversity, hospital or other
Collaborators: ModernaTX, Inc.
Study start: 23 Jan 2024 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 26 Apr 2023 (actual)
Results: Posted 18 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 6 Months
Number of arms: 1

Arm	Type	Receives
Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease	–	Other: Patient Reported OutcomesDiagnosis of multiple myeloma must meet the International Myeloma Working Group criteria.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Key inclusion criteria (4 listed)

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.
Access to the internet
An active patient portal (or willingness to activate)
Willing to electronically sign the study-specific informed consent and authorization form

Key exclusion criteria (3 listed)

Non-English speaking
Lack of internet access
Cognitive impairment precluding ability to provide informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patient Reported OutcomesPatients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.	Other	Diagnosis of multiple myeloma and currently receiving active treatment for any phase of the disease

Primary outcome

Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients.
Time frame: At Baseline
Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients.
Time frame: 30 days after enrollment
Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients.
Time frame: 6 months after enrollment
proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.

10 secondary outcomes

COVID Vaccine Prevalence
Time frame: At Baseline
COVID Booster Incidence
Time frame: 30 Days after enrollment
PRO Review
Time frame: During 6 month study period
COVID-19 Infection Baseline
Time frame: At Baseline
COVID-19 Infection on Study
Time frame: During 6 month study period
Patient Reported COVID 19 Related Outcomes at Baseline
Time frame: At Baseline
Patient Reported COVID 19 Related Outcomes on Study
Time frame: During 6 month study period
EHR COVID 19 Related Outcomes Baseline
Time frame: At Baseline
EHR COVID 19 Related Outcomes on Study
Time frame: During 6 month study period
COVID Booster Incidence
Time frame: 6 months after enrollment

Results and safety

Results posted to the registry on 18 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease	201	196

Primary outcome: Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients.

Time frame: At Baseline. Count of participants. Unit: Participants

Measure	Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease n = 200
Value	196

Primary outcome: Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients.

Time frame: 30 days after enrollment. Count of participants. Unit: Participants

Measure	Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease n = 200
Value	162

Population analysed: 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

Primary outcome: Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients.

Time frame: 6 months after enrollment. Count of participants. Unit: Participants

Measure	Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease n = 200
Value	159

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnosis of Multiple Myeloma and Currently Receiving Active Treatment for Any Phase of the Disease	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41734388Wood 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.
Derived from this study: PubMed 40396505Zorger 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.
Individual participant dataSharing planned: Undecided. There is no plan at this time. All study data will be stored in the ASH RC Data Hub.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Wood, MD, MPH principal investigator

UNC-Chapel Hill

Saad Usmani, MD,MBA,FACP principal investigator

Memorial Sloan Kettering Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by ASH Research Collaborative at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients. (time frame: At Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05831787, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.