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Completed

NCT Number: NCT04830046

Covid-19 Vaccine Responsiveness in MM and Waldenstrom

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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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Effective immune response (EIR) rate at 28 days

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Covid-19 Vaccine Responsiveness in Patients With Multiple Myeloma and Waldenstrom's Macroglobulinemia

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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