A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma

Recruiting now · Phase 1

Conditions studied: Multiple Myeloma

In brief

The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed/refractory multiple myeloma (MM).

Key facts

Study ID

NCT07105059

Run by

Memorial Sloan Kettering Cancer Center

People needed

18

Starts

2025-08-08

Expected to finish

2028-08-08

Last updated by the study team

2026-02-09

Who can join

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

You may qualify if…

• Patients with relapsed or refractory multiple myeloma who have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Patients who have been treated with at least 2 prior lines of therapy are eligible. Multiple myeloma is defined by the International Myeloma Working Group (IMWG) updated criteria.
• Patients need to have measurable disease defined by one or more of the following:
• Serum myeloma (M)-protein greater than or equal to 0.5 g/dL (5 g/L).
• Urine M-protein greater or equal to 200 mg/24 h.
• Involved light chain (either kappa or lambda) >10 mg/dL with an abnormal kappa: lambda ratio
• Plasmacytoma(s) that is new or definitely increased verified by imaging or biopsy.
• Increase is defined as a 50% and at least 1 cm increase as measured serially by the sum of the products of the cross-diameters of the measurable lesion.
• A bone marrow biopsy demonstrating >30% infiltration of clonal plasma cells.
• Patients who have received prior BCMA-directed therapy > 90 days prior including antibody drug conjugates or chimeric antigen receptor T-cell [CAR T] are eligible. BCMA presence on the cell surface should be confirmed in patients who have been treated with prior BCMA targeted therapies. Prior treatment with BCMA targeted bispecific antibodies is not allowed.
• Patients who have received bispecific antibodies >60 days prior with targets other than BCMA are eligible.
• Patients who have received allogeneic stem cell transplantation >6 months prior are eligible.
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. PS-2 is permitted if PS is due solely to bone pain.
• Fulfil the criteria for Adequate Organ System Function Based on Safety Assessments:
• Hematologic:
• Hemoglobin ≥8 g/dL (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted)
• Absolute neutrophil count (ANC) ≥1.0 × 109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated-G-CSF) before the screening and laboratory test
• Platelets ≥75 × 10\^9/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥50×109 /L in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the screening laboratory test)
• Chemistry:
• Total bilirubin ≤2 × ULN; except in subjects with congenital bilirubinemia, such as Gilbert syndrome (in which case if total bilirubin is >2×ULN, then direct bilirubin ≤1.5×ULN is required)
• AST and ALT ≤2.5 × ULN
• eGFR ≥30 mL/min Calculated by CKD-EPI formula adjusted for body surface area (BSA): (mL/min/1.73 m2) x BSA/1.73)
• Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6. mg/dL (≤1.6 mmol/L)
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1, with the exception of peripheral neuropathy attributable to bortezomib.
• Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

You may not qualify if…

• Prior treatment with a BCMA targeted bispecific antibody
• Prior treatment with mezigdomide
• Systemic anti-myeloma therapy (including systemic steroids) within ≤14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
• Use of an investigational drug within 21 days or five half-lives (whichever is longer) preceding the first dose of study drug.
• Radiation therapy within ≤14 days prior to study entry (bone lesions requiring radiation may be treated with limited [i.e., ≤ 25% of bone marrow in field] radiation therapy during this period).
• Live, attenuated vaccine or investigational vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed
• Patients with a history of autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 6 months prior to study enrollment.
• Patients who received CAR T therapy within 90 days prior to study enrollment
• Patients with primary AL amyloidosis will be excluded.
• Participant must not have had major surgery ≤4 weeks prior to initiating study treatment.
• Evidence of active internal bleeding.
• Presence of active renal condition. Participants with isolated proteinuria resulting from multiple myeloma are eligible, provided they fulfill criteria given
• Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
• Subject has active or prior history of malignancy, other than multiple myeloma, unless the subject has been free of the disease or medically stable for ≥ 2 years. The only allowed exceptions are the below listed malignancies treated within the last 24 months and that are considered cured:
• Non-muscle invasive bladder cancer
• Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment) The participant must not be receiving active therapy, other than hormonal therapy for this disease. Presence of low risk prostate cancer per NCCN on active surveillance is permitted.
• Evidence of cardiovascular risk including any of the following:
• Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
• History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening
• Stroke, transient ischemic attack, or seizure within 6 months prior to randomization
• Class III or IV heart failure as defined by the New York Heart Association functional classification system.
• Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to teclistamab or mezigdomide, or any of the components of the study treatment.

Where it is running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.