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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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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):
For WM patients receiving BTK inhibitor (Cohort 2B):
For currently or previously treated WM patients (Cohort 2C):
Exclusion Criteria:
-
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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
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Branagan, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40472329 | Derived | 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. |
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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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008258 | Waldenstrom Macroglobulinemia |
| D007154 | Immune System Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Blood drawn for routine and covid antibody testing
| Boston |
| Massachusetts |
| 02215 |
| United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |