Covid-19 Vaccine Responsiveness in MM and Waldenstrom

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma, Waldenstrom Macroglobulinemia, Immune System Disorder, Covid19

Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Myeloma-MM patients<br>People with Multiple Myeloma-MM receiving covid 19 vaccine | |
| Waldenstrom's macroglobulinemia-WM patients<br>People with Waldenstrom's macroglobulinemia-WM receiving covid 19 vaccine categorized by treatment naïve, actively receiving BTK inhibitor,currently or previously treated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Waldenstrom Macroglobulinemia, Immune System Disorder, Covid 19 Vaccination