Brief Title
Covid-19 Vaccine Responsiveness in MM and Waldenstrom
Official Title
Covid-19 Vaccine Responsiveness in Patients With Multiple Myeloma and Waldenstrom's Macroglobulinemia
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.
Study Type
Observational
Primary Outcome
Effective immune response (EIR) rate at 28 days
Condition
Multiple Myeloma
Study Arms / Comparison Groups
Multiple Myeloma-MM patients
Description: People with Multiple Myeloma-MM receiving covid 19 vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
160
Start Date
September 2021
Completion Date
August 1, 2022
Primary Completion Date
November 1, 2021
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:
-
Gender
All
Ages
18 Years - N/A
Contacts
Andrew Branagan, MD, PhD, (617) 643-4000, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04830046
Organization ID
21-108
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Study Sponsor
Andrew Branagan, MD, PhD, Principal Investigator, Massachusetts General Hospital
Verification Date
March 2021