Phase 1/2 Trial of ABBV-383 for Patients With Relapsed Refractory Waldenström Macroglobulinemia
Mayo Clinic
Summary
This phase I/II trial studies the side effects and best dose of ABBV-383 and to see how well it works in treating patients with Waldenström macroglobulinemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). ABBV-383 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PRE-REGISTRATION: Age ≥ 18 years * PRE-REGISTRATION: Histological confirmation of relapsed and/or refractory Waldenstrom macroglobulinemia, with known prior exposure to a Bruton tyrosine kinase (BTK) inhibitor unless medically contraindicated. Note: although not preferred, archival bone marrow tumor tissue that was collected within 12 weeks prior to screening and without intervening anti- BCMA treatment may be used if the patient is unwilling to provide a fresh pretreatment marrow biopsy * PRE-REGISTRATION: Measurable disease as defined as serum immunoglobulin M (IgM) le…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureComputed Tomography
Undergo CT or PET/CT
- BiologicalEtentamig
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT
- OtherQuestionnaire Administration
Location
- Mayo Clinic in RochesterRochester, Minnesota