Covid-19 Vaccine Responsiveness in MM and Waldenstrom

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04830046

Enrollment

146

Registered

2021-04-02

Start date

2021-04-15

Completion date

2022-09-14

Last updated

2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Immune System Disorder, Multiple Myeloma, Waldenstrom Macroglobulinemia

Keywords

Multiple Myeloma, Waldenstrom Macroglobulinemia, Immune System Disorder, Covid 19 Vaccination

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results