COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies
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ClinicalTrials.gov Identifier: NCT05028374 |
Recruitment Status :
Recruiting
First Posted : August 31, 2021
Last Update Posted : April 14, 2022
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma AL Amyloidosis Chronic Lymphocytic Leukemia | Drug: A single "booster" dose of the Moderna mRNA COVID-19 vaccine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 171 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial Evaluating the Efficacy of Moderna COVID-19 Vaccine Booster Dosing in Patients With Hematologic Malignancies Who Did Not Have an Adequate Response to Prior Vaccination |
Actual Study Start Date : | August 17, 2021 |
Estimated Primary Completion Date : | July 21, 2022 |
Estimated Study Completion Date : | July 21, 2023 |

Arm | Intervention/treatment |
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A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly
The dose of Moderna mRNA vaccine to be administered is the same for all patients in all enrollment cohorts: 0.5 mL administered intramuscularly as a single dose, according to the manufacturer's package insert.
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Drug: A single "booster" dose of the Moderna mRNA COVID-19 vaccine
All participants will receive a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly. This is an open label, non-randomized trial.
Other Name: Covid 19 booster dose |
- Observed response rate of anti-SARS-CoV2 antibody seroconversion. [ Time Frame: 28 days (+/- 3 days) following a booster dose of the Moderna mRNA COVID-19 vaccine ]Anti-SARS-CoV2 IgG antibody seroconversion from negative to positive.
- Observed AEs and SAEs [ Time Frame: Daily phone calls or video chats for 1 week following vaccine administration, and then weekly after that until 4 weeks after vaccination. ]Safety Assessments for AEs and SAEs will be graded according to CTCAE v4 criteria.
- Observed rate of STRONG POSITIVE anti-SARS-CoV2 antibody response [ Time Frame: measured 28 days (+/- 3 days) following a booster dose of the Moderna COVID-19 vaccine. ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years of age or older
- Previously diagnosed with MM/AL amyloidosis (Cohorts 1 or 3) or other hematologic malignancy (Cohorts 2 or 3).
- Previously received any one of the available COVID-19 vaccines (between 4 and 36 weeks prior to enrollment)
- 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.
- 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:
- 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)
- History of previous severe reaction to any available COVID-19 vaccine (defined as any Grade 3 or higher reaction)
- Febrile illness within 3 days of booster dosing.
- Documented SARS-CoV2 infection within 2 weeks of enrollment.
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05028374
Contact: Cathy Galasso, RN | 313-576-8453 | galassoc@karmanos.org | |
Contact: Jeffrey Zonder, MD | 313-576-8673 | zonderj@karmanos.org |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Jeffrey A. Zonder 313-576-9363 zonderj@karmanos.org | |
Principal Investigator: Jeffrey A. Zonder, M.D. | |
Sub-Investigator: Abhinav Deol, M.D. | |
Sub-Investigator: Jay Yang, M.D. | |
Sub-Investigator: Melissa Runge-Moris, M.D. | |
Sub-Investigator: Asif Alavi, M.D. | |
Sub-Investigator: Andrew Kin, M.D. | |
Sub-Investigator: Asfar Azmi, PhD | |
Sub-Investigator: Joseph Uberti, M.D. | |
Sub-Investigator: Lois Ayash, M.D. | |
Sub-Investigator: Dipenkumar Modi, M.D. |
Principal Investigator: | Jeffrey A. Zonder, M.D. | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Jeffrey Zonder, Principal Investigator, Barbara Ann Karmanos Cancer Institute |
ClinicalTrials.gov Identifier: | NCT05028374 |
Other Study ID Numbers: |
2021-036 |
First Posted: | August 31, 2021 Key Record Dates |
Last Update Posted: | April 14, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Multiple Myeloma Leukemia, Lymphocytic, Chronic, B-Cell Hematologic Neoplasms Immunoglobulin Light-chain Amyloidosis Amyloidosis Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Leukemia Lymphatic Diseases Leukemia, B-Cell Neoplasms by Site Proteostasis Deficiencies Metabolic Diseases |