A Phase 1b Trial of Teclistamab in Combination With Iberdomide for Relapsed/Refractory Multiple Myeloma
National Cancer Institute (NCI)
Summary
This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. 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). Immunotherapy with monoclonal antibodies, such as teclistamab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving iberdomide in combination with teclistamab may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma.
Description
PRIMARY OBJECTIVE: I. Estimate the recommended phase 2 dose (RP2D) of iberdomide in combination with teclistamab. SECONDARY OBJECTIVES: I. To evaluate the safety and toxicity profile of iberdomide in combination with teclistamab. II. To observe and record antitumor activity. CORRELATIVE OBJECTIVES: I. To evaluate the changes in the tumor immune microenvironment (exhausted T-cell phenotypes, percent T regulatory cells \[T regs\], T-cell activation) in peripheral blood and bone marrow caused by the addition of iberdomide to teclistamab and how they relate to minimal residual disease (MRD)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically or cytologically confirmed multiple myeloma (MM), as defined in the International Myeloma Working Group (IMWG) criteria * If patients have undergone autologous stem cell transplant (SCT), day 0 of SCT must be \> 100 days to be eligible for the study * Patients must have had disease progression after ≥ 4 prior lines of anti-myeloma treatments including one proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), one immunomodulatory imide drug (ImiD) (e.g., thalidomide, lenalidomide, pomalidomide \[POM\]), and one anti-CD38 monoclo…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
- ProcedureBone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
- ProcedureComputed Tomography
Undergo PET/CT
- DrugIberdomide
Given PO
- ProcedureMagnetic Resonance Imaging
Undergo PET/MR
- ProcedurePositron Emission Tomography
Locations (14)
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Smilow Cancer Hospital-Derby Care CenterDerby, Connecticut
- Smilow Cancer Hospital Care Center - GuilfordGuilford, Connecticut
- Yale UniversityNew Haven, Connecticut
- Yale-New Haven Hospital North Haven Medical CenterNorth Haven, Connecticut
- Mayo Clinic in FloridaJacksonville, Florida