Study Details

Open

Relapsed or Refractory Multiple Myeloma: Safety and Dose Optimization of ABBV-383

The purpose of this study is to see if ABBV-383 administered alone in increasing doses is tolerated and safe for people with relapsed/refractory multiple myeloma (MM). This is a phase 1b study.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

To figure out if you are good candidate for this study, we will explain the study in detail and do some assessments. Those include questionnaires, a physical exam, an evaluation to determine how you are able to complete daily activities, an EKG, blood and urine tests, a bone marrow biopsy and bone marrow aspirate, a skeletal survey (X-ray, CT, PET-CT, or MRI), and a plasmacytoma evaluation. If you are a good fit, you will move into the treatment phase of the study. where you will receive IV infusions of ABBV-383 in cycles and according to the dose group that you are randomly assigned to. During this phase, we'll monitor you closely to reduce the risk of infusion-related reaction (IRR) or immune-mediated toxicity (IMIT). We'll also repeat many of the same evaluations listed above, Safety follow-up and assessments will be done regularly throughout your time in the study.

Incentives

You or your insurance provider will not have to pay for ABBV-383 or study-related procedures while you take part in this study.

In-person visits:
Screening visit, hospital admissions for inpatient administration of study drug on days 1 and 4 of the first cycle, three subsequent outpatient visits during cycle 1, one visit for each additional cycle, end of treatment visit, safety follow-up visit 90 days after last dose

Total length of participation:
You may continue treatment until disease progression, withdrawal, or discontinuation.

Looking for Specific Volunteers

Able to participate:

You have a confirmed diagnosis of multiple myeloma that has not responded to treatment or has come back after your last treatment.
You have received at least three prior lines (combinations) of chemotherapy, including each of the following: proteasome inhibitor, immunomodulatory agent, anti-CD38 monoclonal antibody.
You have not received any prior treatment targeting BCMA (e.g. teclistamab, Idecabtagene vicleucel [ide-cel], ciltacabtagene autoleucel [cilta-cel], or prior treatment with ABBV-383).
Your laboratory test results (e.g. blood counts, liver function tests, kidney function tests, and calcium level) must meet certain criteria.
You have "measurable" disease at screening, i.e. your involved serum free light chain, serum M-protein, and/or urine M-protein must be above a certain threshold.

Not eligible if:

You have received an autologous stem cell transplant within the past 12 weeks or an allogeneic stem cell transplant within the past year.
You have a history of other cancers within the past three years, with some exceptions.
You have an active infection with HIV, hepatitis B, or hepatitis C.
You have active plasma cell leukemia and/or multiple myeloma that has affected your central nervous system.
You are pregnant or are planning to become pregnant (female patients), or you are considering fathering a child or donating sperm (male patients).

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Eben Lichtman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Phase 1 Trials (all cancers), Multiple Myeloma)

IRB Number

23-0285

ClinicalTrials.gov

NCT05650632