Study Details

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Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

This study is being done to answer the following questions: 1) Can the study drug iberdomide be given after idecabtagene vicleucel (ide-cel (Abecma)) CAR-T in multiple myeloma safely and with acceptably few and mild side effects? 2) For how long does multiple myeloma stay under control (in remission) if patients receive the study drug iberdomide after they have received ide-cel (Abecma) CAR-T? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.

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

The following tests and procedures will be done on this study: medical history review, full or symptom-directed physical, pulse, blood pressure, weight, adverse event assessment, patient medication diary review, pregnancy prevention counseling, Iberdomide dispensing, complete blood count (CBC) with differential, complete metabolic profile, blood lactate dehydrogenase and beta-2-microglobulin, serum HCG, serum protein electrophoresis, serum immunofixation quantitative immunoglobulins, serum free light chains, 24 hour urine protein electrophoresis and immunofixation, bone marrow biopsy and aspirate, CT/MRI/PET scans, tissue and blood samples for correlative studies.

Incentives

You or your insurance provider will not have to pay for the iberdomide while you take part in this study.

In-person visits:
At least 10, depending on length of treatment

Phone or online visits:
On survival follow-up, every six months up to four years post registration

Total length of participation:
four years

Looking for Specific Volunteers

Able to participate:

You have diagnostically confirmed Multiple Myeloma in response status of stable disease or better.
You have recieved ide-cel CAR-T within 80-110 days of registration.
You have had greater than or equal to four lines of therapy for Multiple Myeloma.
You have an ECOG Performance Status less than or equal to two.
You have adequate bone marrow and liver function per protocol required lab values.

Not eligible if:

You have received Multiple Myeloma-directed therapy since ide-cel CAR-T infusion.
You have previously taken iberdomide and your Multiple Myeloma came back while you were taking it.
You have POEMS syndrome or amyloidosis involving any vital organ.
You have a prior or current malignancy whose natural history or treatment would interfere with the safety or efficacy of the study treatment.
You currently have an active infection. (Some exceptions are acceptable.)

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
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

Sascha Tuchman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Multiple Myeloma)

IRB Number

24-1088

ClinicalTrials.gov

NCT06179888