COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies
Condition: Multiple Myeloma; AL Amyloidosis; Chronic Lymphocytic Leukemia
MeSH terms: Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: A single "booster" dose of the Moderna mRNA COVID-19 vaccine
Intervention description: All participants will receive a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly. This is an open label, non-randomized trial.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine whether protective antibody levels increase after booster dosing with the
      Moderna COVID-19 vaccine in patients diagnosed with Hematologic Malignancies who have low
      antibody levels after a prior first vaccination with any of the SARS-CoV2 vaccines that were
      authorized for use in the USA. Researchers will also assess whether the booster dosing with
      the Moderna COVID-19 vaccine is safe in patients with multiple myeloma, amyloidosis, or other
      blood cancers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of signed and dated informed consent form

          2. Stated willingness to comply with all study procedures and availability for the
             duration of the study

          3. Male or female, aged 18 years of age or older

          4. Previously diagnosed with MM/AL amyloidosis (Cohorts 1 or 3) or other hematologic
             malignancy (Cohorts 2 or 3).

          5. Previously received any one of the available COVID-19 vaccines (between 4 and 36 weeks
             prior to enrollment)

          6. Anti-SARS-CoV2 IgG antibody titer of results less than 1.0 units (Cohorts 1 and 2), or
             1.0-1.99 units (Cohort 3). Antibody titers will be measured within 14 days of
             enrollment.

          7. If currently receiving potentially immunosuppressive anti-neoplastic therapy for their
             underlying hematologic condition, a two-week interruption in therapy before and after
             the booster dose of vaccine is ENCOURAGED BUT NOT REQUIRED (physician discretion).-

        Exclusion Criteria:

          1. Daily corticosteroids at a dose equivalent to Prednisone 20 mg/day or greater during
             the period two weeks before enrollment to the trial. Intermittent steroid dosing at or
             above this level is permitted (i.e., weekly dexamethasone dosing as part of myeloma
             therapy)

          2. History of previous severe reaction to any available COVID-19 vaccine (defined as any
             Grade 3 or higher reaction)

          3. Febrile illness within 3 days of booster dosing.

          4. Documented SARS-CoV2 infection within 2 weeks of enrollment.

          5. Less than 3 months post-autologous or allogeneic stem cell transplant (NOTE:
             transplant between initial standard vaccine administration and enrollment is NOT
             otherwise grounds for exclusion from participation).