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NCT05028374 · STUDY IN CONTEXT

COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.

Participants who received a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly.

→

secondary · POSTED

A STRONG POSITIVE response is defined in this trial as an anti-SARS-CoV2 IgG antibody titer of at least 2 S/CO 28 days (+/- 3 days) following vaccine administration

Participants who received a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT05028374
trial label
COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    outcome key
    om-0000
    source section id
    NCT05028374-om-0000
    source outcome index
    0
    endpoint
    Observed Response Rate of Anti-SARS-CoV2 Antibody Seroconversion.
    endpoint definition
    Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.
    time origin
    28 days (+/- 3 days) following a booster dose of the Moderna mRNA COVID-19 vaccine
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    outcome key
    om-0001
    source section id
    NCT05028374-om-0001
    source outcome index
    1
    endpoint
    Observed Rate of STRONG POSITIVE Anti-SARS-CoV2 Antibody Response
    endpoint definition
    A STRONG POSITIVE response is defined in this trial as an anti-SARS-CoV2 IgG antibody titer of at least 2 S/CO 28 days (+/- 3 days) following vaccine administration
    time origin
    measured 28 days (+/- 3 days) following a booster dose of the Moderna COVID-19 vaccine.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who received a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1
    regimen
    Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05028374-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort 2
    regimen
    Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05028374-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Cohort 3
    regimen
    Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05028374-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort 1
    regimen
    Multiple myeloma and amyloidosis patients who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05028374-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cohort 2
    regimen
    Patients with other hematologic malignancies who did not develop an anti-spike antibody titer of \>1 S/CO after prior COVID-19 vaccination.
    analyzed count
    50
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05028374-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Cohort 3
    regimen
    Patients with multiple myeloma, amyloidosis, or other hematologic malignancy who had a "weak positive" response to prior COVID-19 vaccine, defined as an anti-spike antibody titer of 1-2 S/CO.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05028374-om-0001#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    harm key
    EG000
    source section id
    NCT05028374-ae
    event group key
    EG000
    event group label
    Cohort 1
    serious affected
    0
    serious at risk
    52
    other affected
    48
    other at risk
    52
    frequency threshold
    0
    collection period
    Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    harm key
    EG001
    source section id
    NCT05028374-ae
    event group key
    EG001
    event group label
    Cohort 2
    serious affected
    0
    serious at risk
    50
    other affected
    47
    other at risk
    50
    frequency threshold
    0
    collection period
    Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT05028374
    harm key
    EG002
    source section id
    NCT05028374-ae
    event group key
    EG002
    event group label
    Cohort 3
    serious affected
    1
    serious at risk
    16
    other affected
    16
    other at risk
    16
    frequency threshold
    0
    collection period
    Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice