Clinical trial · Observational
Covid-19 Vaccine Responsiveness in MM and Waldenstrom
Covid-19 Vaccine Responsiveness in Patients With Multiple Myeloma and Waldenstrom's Macroglobulinemia
NCT04830046CI-TRIAL-00097969completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Covid19 | — | UNRESOLVED | — |
| Immune System Disorder | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Waldenstrom Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Multiple Myeloma-MM patients
- description
- People with Multiple Myeloma-MM receiving covid 19 vaccine
- label
- Waldenstrom's macroglobulinemia-WM patients
- description
- People with Waldenstrom's macroglobulinemia-WM receiving covid 19 vaccine categorized by treatment naïve, actively receiving BTK inhibitor,currently or previously treated.
Primary outcomes (1)
- measure
- Effective immune response (EIR) rate at 28 days
- timeFrame
- 28 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (1)
- DERIVEDBranagan 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 40472329