NCT06465316

Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma

A Phase 1b Trial of Teclistamab in Combination With Iberdomide for Relapsed/Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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) status, responses rates and survival outcomes. II. To evaluate soluble B-cell maturation antigen (sBCMA) levels at baseline and how they correlate to response rates and survival outcomes in patients treated with teclistamab plus iberdomide. III. To identify the immunophenotypic and transcriptomic characterization of malignant plasma cells that are resistant to teclistamab and iberdomide. OUTLINE: This is a dose-escalation study of iberdomide in combination with teclistamab. Patients receive teclistamab subcutaneously (SC) on days 1, 4, 7, 15 and 22 for cycle 1 and days 1, 8, 15 and 22 for subsequent cycles. Patients also receive iberdomide orally (PO) once daily (QD) on days 1-21 for cycle 2 and beyond. Cycles repeat every 28 days for up to 4 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood and urine sample collection, bone marrow aspiration and biopsy and positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MR) throughout the trial. After completion of study treatment, patients are followed up every 3-6 months for up to 2 years.

Conditions

• Recurrent Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood and urine sample collection
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration and biopsy
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow aspiration and biopsy
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	Iberdomide	Given PO
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MR
PROCEDURE	Positron Emission Tomography	Undergo PET/CT or PET/MR
DRUG	Teclistamab	Given SC

Timeline

• Start date: 2024-12-06
• Primary completion: 2026-09-16
• Completion: 2026-09-16
• First posted: 2024-06-18
• Last updated: 2026-04-13

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study