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People with Multiple Myeloma-MM receiving covid 19 vaccine

People with Waldenstrom's macroglobulinemia-WM receiving covid 19 vaccine categorized by treatment naïve, actively receiving BTK inhibitor,currently or previously treated.

Andrew Branagan, MD, PhD

Clifton Mo, MD

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.

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.

Blood drawn for routine and covid antibody testing

Covid-19 Vaccine Responsiveness in MM and Waldenstrom

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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.

Massachusetts General Hospital

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Covid-19 Vaccine Responsiveness in MM and Waldenstrom	NCT04830046	Multiple Myelom... Waldenstrom Mac... Immune System D... Covid19		18 Years -	Massachusetts General Hospital
Covid-19 Vaccine Responsiveness in MM and Waldenstrom	NCT04830046	Multiple Myelom... Waldenstrom Mac... Immune System D... Covid19		18 Years -	Massachusetts General Hospital

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