A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Running, not enrolling · Phase 1

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).

Key facts

Study ID

NCT06425991

Run by

Janssen Research & Development, LLC

People needed

108

Starts

2024-06-07

Expected to finish

2028-01-13

Last updated by the study team

2026-07-31

Who can join

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

You may qualify if…

• Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
• Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line
• Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria
• Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study

You may not qualify if…

• Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
• Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed
• Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required
• Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Augusta University- Georgia Cancer Center — Augusta, Georgia, United States
• St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health — Indianapolis, Indiana, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Flinders Medical Centre — Bedford Park, Australia
• Box Hill Hospital — Box Hill, Australia
• Royal Prince Alfred Hospital — Camperdown, Australia
• Epworth Healthcare — Richmond, Australia
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Princess Margaret Cancer Centre University Health Network — Toronto, Ontario, Canada
• CHRU de Lille Hopital Claude Huriez — Lille, France
• Hospices Civils de Lyon HCL — Lyon, France
• CHU Nantes — Nantes, France
• CHU de Bordeaux - Hospital Haut-Leveque — Pessac, France
• Klinikum Chemnitz gGmbH — Chemnitz, Germany
• Universitaetsklinikum Hamburg Eppendorf — Hamburg, Germany
• Universitaetsklinikum Heidelberg — Heidelberg, Germany
• Universitatsklinikum Wurzburg — Würzburg, Germany
• Carmel Medical Center — Haifa, Israel
• Hadassah University Hospita Ein Kerem — Jerusalem, Israel
• Sheba Medical Center — Ramat Gan, Israel
• Sourasky Medical Center — Tel Aviv, Israel
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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