Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Hard-to-Treat Multiple Myeloma
NCT Number: NCT06465316
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Multiple Myeloma
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Bone Marrow Aspiration|PROCEDURE: Bone Marrow Biopsy|PROCEDURE: Computed Tomography|DRUG: Iberdomide|PROCEDURE: Magnetic Resonance Imaging|PROCEDURE: Positron Emission Tomography|DRUG: Teclistamab
Sponsor: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-16
Completion Date: 2027-01-30

Summary:
This phase Ib trial tests the safety, side effects, and best dose of iberdomide in combination with teclistamab in treating hard-to-treat multiple myeloma. 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 multiple myeloma.

Primary Outcome Measures: Recommended phase 2 dose (RP2D) of iberdomide when combined with teclistamab, The RP2D will be defined as the maximum tolerated dose (MTD), or as the highest dose level safely tested if the MTD is not reached., At 28 days
Secondary Outcome Measures: Incidence of adverse events (AEs), AEs will be described and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The relationship of the AEs to the study treatment will be taken into consideration., Up to 4 weeks after last dose of study treatment|Incidence of grade 3 or higher AE, AEs will be described and graded using the NCI CTCAE v5.0. The overall AE rate for grade 3 or higher hematologic and non-hematologic AEs at least possibly related to treatment will be evaluated using the chi-square test (or Fisher's exact test if the data in the contingency table is sparse)., Up to 4 weeks after last dose of study treatment|Overall response rate (ORR), The ORR will be estimated by the total number of patients who achieve a stringent complete response, complete response, very good partial response, or partial response divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate will be calculated., Up to 2 years after last dose of study treatment|Minimal residual disease (MRD) negativity, MRD negativity will be summarized descriptively at each specified timepoint., Up to 2 years after last dose of study treatment|Progression-free survival (PFS), The distribution of PFS will be estimated using the method of Kaplan-Meier and will be evaluated using log-rank statistics., From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 years after last dose of study treatment|Time to progression, The distribution of time to progression will be estimated using the method of Kaplan-Meier and will be evaluated using log-rank statistics., From registration to the earliest date of documentation of disease progression, assessed up to 2 years after last dose of study treatment|Duration of response (DOR), The distribution of DOR will be estimated using the method of Kaplan-Meier and will be evaluated using log-rank statistics., From earliest documentation of disease response to disease progression, assessed up to 2 years after last dose of study treatment|Overall survival (OS), The distribution of OS will be estimated using the method of Kaplan-Meier and will be evaluated using log-rank statistics., From registration to death due to any cause, assessed up to 2 years after last dose of study treatment
Other Outcome Measures: Tumor immune microenvironment, Flow cytometry will be utilized to assess the tumor immune microenvironment in the bone marrow and peripheral blood at baseline and during active treatment at specified time points. Values over time will be summarized graphically and descriptively. Paired sample approaches (Wilcoxon signed rank test) will be used to assess differences over time. The relationship between changes over time in each measure with response outcome measures will be explored using Wilcoxon's rank sum test., Up to 2 years after last dose of study treatment|Soluble B-cell maturation antigen levels, Values over time will be summarized graphically and descriptively. Paired sample approaches (Wilcoxon signed rank test) for these types of quantitative measures will be used to assess differences over time. The relationship between changes over time in each measure with response outcome measures will be explored using Wilcoxon's rank sum test., At baseline