Covid-19 Vaccine Responsiveness in MM and Waldenstrom

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-09-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma Waldenstrom Macroglobulinemia Immune System Disorder Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Myeloma-MM patients

People with Multiple Myeloma-MM receiving covid 19 vaccine

No interventions assigned to this group

Waldenstrom's macroglobulinemia-WM patients

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

No interventions assigned to this group

Eligibility Criteria

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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.