Covid-19 Vaccine Responsiveness in MM and Waldenstrom
1 other identifier
observational
146
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 2, 2021
CompletedStudy Start
First participant enrolled
April 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2022
CompletedNovember 26, 2025
November 1, 2025
5 months
March 31, 2021
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Eligibility Criteria
People with Multiple Myeloma-MM and Waldenstrom's macroglobulinemia-WM receiving covid 19 vaccine. People with Waldenstrom's macroglobulinemia-WM are categorized by treatment naïve, actively receiving BTK inhibitor,currently or previously treated
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (1)
Branagan AR, Mo C, Lei M, Gustine JN, Yee AJ, O'Donnell E, Castillo JJ, Nadeem O, Flynn C, Bernstein Z, Nakamoto-Matsubara R, Meid K, Verma R, Hunter ZR, Guerrera ML, Alter G, Burke J, Harrington C, Agyemang E, Gammon M, Lively K, Packer L, Horick N, Laubach J, Mitsiades CS, Munshi N, Anderson KC, Treon SP, Richardson PG, Raje NS, Sarosiek SR. Prospective study of immunogenicity to SARS-CoV-2 booster vaccines in multiple myeloma and Waldenstrom macroglobulinemia. Blood Adv. 2025 Sep 23;9(18):4568-4579. doi: 10.1182/bloodadvances.2025016513.
PMID: 40472329DERIVED
Biospecimen
Blood drawn for routine and covid antibody testing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Branagan, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 31, 2021
First Posted
April 2, 2021
Study Start
April 15, 2021
Primary Completion
September 14, 2021
Study Completion
September 14, 2022
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.