Covid-19 Vaccine Responsiveness in MM and Waldenstrom

Mass General Brigham

Status: Unknown

Conditions: Immune System Disorder; Waldenstrom Macroglobulinemia; Multiple Myeloma; Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04830046

21-108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

Multiple Myeloma-MM patients

Description:

People with Multiple Myeloma-MM receiving covid 19 vaccine

Waldenstrom's macroglobulinemia-WM patients

Description:

People with Waldenstrom's macroglobulinemia-WM receiving covid 19 vaccine categorized by treatment naïve, actively receiving BTK inhibitor,currently or previously treated.