Covid-19 Vaccine Responsiveness in MM and Waldenstrom

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Overview

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.

SparkCures ID 1156
Trial Phase Observational Trial
Enrollment 160 Patients
Tags
Trial Sponsors
  • Massachusetts General Hospital
NCT Identifier

NCT04830046

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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:
None listed

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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