Status:

COMPLETED

Covid-19 Vaccine Responsiveness in MM and Waldenstrom

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Multiple Myeloma

Waldenstrom Macroglobulinemia

Eligibility:

All Genders

18+ years

Brief 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.

Detailed 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 antibod...

Eligibility Criteria

Inclusion

  • 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

  • \-

Key Trial Info

Start Date :

April 15 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 14 2022

Estimated Enrollment :

146 Patients enrolled

Trial Details

Trial ID

NCT04830046

Start Date

April 15 2021

End Date

September 14 2022

Last Update

November 26 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02215

2

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215