ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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 criteria
Qualifiers
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) levels ≥ 0.5 g/dL (500 mg/dL)
PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Disqualifiers
Pregnant persons
Nursing persons
Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
PRE-REGISTRATION: Subject has known allergic reaction, significant sensitivity, or intolerance to constituents of the study drugs (and excipients) and/or other products in the same class
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Marrow Aspiration
- Bone Marrow Biopsy
- Computed Tomography
- Etentamig
- Positron Emission Tomography
- Questionnaire Administration
Treatment groups
38 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov