← Back to Search

Virus Therapy

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

Phase 2

Waitlist Available

Led By Jeffrey A. Zonder, M.D.

Research Sponsored by Barbara Ann Karmanos Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days (+/- 3 days) following a booster dose of the moderna mrna covid-19 vaccine

Awards & highlights

Study Summary

This trial will test whether a booster dose of the Moderna COVID-19 vaccine can increase antibody levels in patients with blood cancers who have low levels after their first vaccination.

Eligible Conditions

Multiple Myeloma
AL Amyloidosis
Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured 28 days (+/- 3 days) following a booster dose of the moderna covid-19 vaccine.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured 28 days (+/- 3 days) following a booster dose of the moderna covid-19 vaccine.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 28 days (+/- 3 days) following a booster dose of the moderna covid-19 vaccine. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Side effects data

From 2021 Phase 2 trial • 119 Patients • NCT05028374

69%

Injection site reaction

23%

Fatigue

19%

Myalgia

12%

Headache

12%

Nausea

Diarrhea

Chills

Arthritis

Back pain

Fever

Pain in extremity

Rash acneiform

Anorexia

Bruising

Hypotension

Edema limbs

Localized edema

Dyspnea

Cardiac disorders - Other

Irritability

Hyperhidrosis

Neutrophil count decreased

Bone pain

Tinnitus

Sinus tachycardia

Dehydration

Constipation

Eye disorders - Other

Hyperglycemia

Gastrointestinal pain

Dizziness

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Syncope

Cough

Renal and urinary disorders - Other, specify

Suicidal ideation

Paresthesia

Nasal congestion

Insomnia

Pelvic pain

Pruritus

Urticaria

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1

Cohort 2

Cohort 3

Trial Design

1Treatment groups

Experimental Treatment

Group I: A single "booster" dose of the Moderna mRNA COVID-19 vaccine administered intramuscularlyExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2021

Completed Phase 2

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor

163 Previous Clinical Trials

9,167 Total Patients Enrolled

24 Trials studying Multiple Myeloma

1,262 Patients Enrolled for Multiple Myeloma

Jeffrey A. Zonder, M.D.Principal InvestigatorBarbara Ann Karmanos Cancer Institute

1 Previous Clinical Trials

35 Total Patients Enrolled

1 Trials studying Multiple Myeloma

35 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does this treatment's safety profile look to you?

"While there is some safety data from preclinical studies, this treatment received a score of 2 because Phase 2 trials have not yet demonstrated efficacy in humans."

Answered by AI

Are we still recruiting patients for this experiment?

"The clinical trial is not enrolling patients at the moment, however according to information found on clinicaltrials.gov, this could change in the future as the study was most recently edited on 8/24/2022. There are also many other trials (1472) that are actively enrolling patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies

Jeffrey Zonder 2021. "COVID-19 VAX Booster Dosing in Patients With Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05028374.