Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment

Recruiting now · Phase 1/Phase 2

Conditions studied: Recurrent Multiple Myeloma, Refractory Multiple Myeloma

In brief

This phase Ib/II trial compares the effect of teclistamab and pomalidomide to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Carfilzomib blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. It is a type of proteasome inhibitor. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving teclistamab and pomalidomide may be safe, tolerable and improve response by lowering myeloma cells to undetectable levels when compared to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with relapsed multiple myeloma.

Key facts

Study ID: NCT07463807
Run by: National Cancer Institute (NCI)
People needed: 162
Starts: 2027-04-12
Expected to finish: 2029-03-31
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must be ≥ 18 years of age
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patient must have an identifiable dominant sequence (clonotype) established based on Adaptive Biotechnologies clonoSEQ® assay for Phase II only
Patient must have multiple myeloma and meet both of the following criteria for the original diagnosis of myeloma following the International Myeloma Working Group (IMWG) myeloma diagnostic criteria:
Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma.
Tissue biopsy of any bone lesion or extramedullary plasmacytoma if applicable (positive/negative for clonal plasma cells)
Any one or more of the following symptomatic myeloma-defining events that prompted initiation of therapy as well as end-organ damage:
Anemia (hemoglobin value of > 2 g/dL below the lower limit of normal, or a hemoglobin value < 10 g/dL)
Hypercalcemia (serum calcium > 1 mg/dL higher than the upper limit of normal or > 11 mg/dL)
Bone disease (one or more osteolytic lesions on skeletal radiography, CT, or FDG-PET/CT)
Renal dysfunction (creatinine clearance < 40 mL/min or serum creatinine > 2 mg/dL).
Clonal bone marrow plasma cells (BMPCs) ≥ 60%
Involved/uninvolved serum free light chain ratio ≥ 100
> 1 focal lesions on magnetic resonance imaging (MRI) studies ≥ 5 mm
NOTE: Patients with smoldering myeloma (serum m protein ≥ 3 gm/dL or bone marrow plasma cells ≥ 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal gammopathy of undetermined significance (serum m protein < 3 gm/dL and bone marrow plasma cells < 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) are not eligible
Patient must have experienced relapse disease defined as relapse after one line of lenalidomide therapy including single agent lenalidomide or lenalidomide/dexamethasone or CD38 antibody/lenalidomide +/- dexamethasone. The relapse can be progressive disease as determined by the treating clinician and meeting measurable disease criteria
Patient must have received no more than two lines of IMWG defined therapy (induction +/- transplant + maintenance is considered a single line of therapy)
Patient must not receive non-protocol concurrent chemotherapy for the study disease, or any ancillary therapy considered investigational while participating in the study
Patient must have received an immunomodulatory drug (lenalidomide) and a CD38 antibody (daratumumab or isatuximab)
Patient must have measurable disease as defined by having one or more of the following, obtained within 28 days prior to registration/randomization:
≥ 0.5 g/dL monoclonal protein (M-protein) on serum protein electrophoresis
≥ 200 mg/24 hrs of monoclonal protein (M-protein) on a 24-hour urine protein electrophoresis
Involved free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65)
Exception: patients without measurable disease in the serum or urine, but with bone or soft tissue plasmacytoma(s) ≥ 2 cm or who have bone marrow plasma cells ≥ 30% are eligible on study
NOTE: Urine protein electrophoresis (UPEP) (on a 24 hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg/24 hr. Please note that if both serum and urine m-components are present, both must be followed in order to evaluate response

Where it is running

ECOG-ACRIN Cancer Research Group — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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