Clinical trial NCT04830046: Covid-19 Vaccine Responsiveness in MM and Waldenstrom
Official title: Covid-19 Vaccine Responsiveness in Patients With Multiple Myeloma and Waldenstrom's Macroglobulinemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Waldenstrom Macroglobulinemia
Immune System Disorder
Covid19
Keywords: Multiple Myeloma
Waldenstrom Macroglobulinemia
Immune System Disorder
Covid 19 Vaccination
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Multiple Myeloma-MM and Waldenstrom's macroglobulinemia-WM receiving covid 19 vaccine.

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

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 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Effective immune response (EIR) rate at 28 days
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew Branagan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: