Covid-19 Vaccine Responsiveness in MM and Waldenstrom

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04830046

Collaborator

(none)

160

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Waldenstrom Macroglobulinemia Immune System Disorder Covid19

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 Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Multiple Myeloma-MM patients People with Multiple Myeloma-MM receiving covid 19 vaccine
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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.