COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies

NCT05028374 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2021-036
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma; AL Amyloidosis; Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Observed Response Rate of Anti-SARS-CoV2 Antibody Seroconversion.

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

  28 days (+/- 3 days) following a booster dose of the Moderna mRNA COVID-19 vaccine

Secondary Outcomes (1)

• Observed Rate of STRONG POSITIVE Anti-SARS-CoV2 Antibody Response

  measured 28 days (+/- 3 days) following a booster dose of the Moderna COVID-19 vaccine.

Study Arms (1)

A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly

OTHER

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.

Drug: A single "booster" dose of the Moderna mRNA COVID-19 vaccine

Interventions

A single "booster" dose of the Moderna mRNA COVID-19 vaccine DRUG

All participants will receive a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly. This is an open label, non-randomized trial.

Also known as: Covid 19 booster dose

A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jeffery Zonder
• Organization: Karmanos Cancer Institute

zonderj@karmanos.org

313-576-8732

Study Officials

• Jeffrey A. Zonder, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 31, 2021
• Study Start: August 17, 2021
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: December 20, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-11

Locations

US (1)