Covid-19 Vaccine Responsiveness in MM and Waldenstrom

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04830046
• Other study ID #: 21-108
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2021
• Source: Massachusetts General Hospital
• Contact: Andrew Branagan, MD, PhD
• Phone: (617) 643-4000
• Email: abranagan[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: August 1, 2022
• Est. primary completion date: November 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Covid19
• Immune System Diseases
• Immune System Disorder
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Waldenstrom Macroglobulinemia

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective immune response (EIR) rate at 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.	28 days