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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04830046
Other study ID # 21-108
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2021
Est. completion date August 1, 2022

Study information

Verified date March 2021
Source Massachusetts General Hospital
Contact Andrew Branagan, MD, PhD
Phone (617) 643-4000
Email abranagan@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This research is being done to see if the immune (defense) system of people with Multiple Myeloma and Waldenstrom's Macroglobulinemia reacts to the COVID-19 vaccine.


Description:

COVID-19 vaccines are designed to help prevent infections, hospitalizations, and death from the COVID-19 virus. Normally, when the vaccine is administered, the immune system reacts by creating antibodies (proteins made by the body's immune system to fight infections such as COVID-19) and helping the immune system's blood cells to fight it. In people with Multiple Myeloma and Waldenstrom's Macroglobulinemia, their immune system does not function normally, and an effective immune response may not occur. The research study procedures include screening for eligibility and the collection of data and biospecimens. It is expected that about 160 people will take part in this research study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 160
Est. completion date August 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >18 years. - Lack of a contra-indication to a currently available COVID-19 vaccine. - Diagnosis of MM according to International Myeloma Working Group (IWMG) criteria (Cohort 1) or Diagnosis of WM according to WHO criteria (Cohort 2) - For treatment naïve WM patients (Cohort 2A): - Patient must have no prior history of anticancer treatment for WM. - The treating investigator must have no intention to initiate WM therapy within 2 months - For WM patients receiving BTK inhibitor (Cohort 2B): - Patient must have no history of cytotoxic chemotherapy within 1 year, and no history of other anticancer therapy within 6 months. - For currently or previously treated WM patients (Cohort 2C): - Patient must not be currently taking a BTK inhibitor or had recent exposure within 1 month of enrollment. Current or prior history of any other WM-directed therapy is allowed. Exclusion Criteria: -

Study Design


Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effective immune response (EIR) rate at 28 days The primary endpoint is the effective immune response (EIR) rate at 28 days following the second or final vaccine dose. EIR will be defined by a positive SARS-CoV-2 spike antibody index (S/C). The EIR rate will be reported along with the exact 95% confidence interval. 28 days
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