Teclistamab: Teclistamab will be administered subcutaneously.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab — Cycle 1 (28 days cycle): Predose to Day 7 postdose Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose).
Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose — Cycle 1 (28 days cycle): Predose to Day 7 postdose AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose).
Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1 — Cycle 3 (28 days cycle): Day 1 Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration.
Trial sites (53)
Facility
City
Region
Status
Banner MD Anderson Cancer Center
Gilbert
Arizona
Colorado Blood Cancer Institute
Denver
Colorado
Cleveland Clinic Florida
Weston
Florida
Augusta University- Georgia Cancer Center
Augusta
Georgia
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health
Indianapolis
Indiana
Cleveland Clinic
Cleveland
Ohio
Baylor University Medical Center
Dallas
Texas
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
Princess Margaret Cancer Centre University Health Network
Toronto
Ontario
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
Ospedali Riuniti Di Ancona
Ancona
Italy
ASST Papa Giovanni XXIII Bergamo
Bergamo
Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
Italy
Ospedale Santa Chiara AO Universitaria Pisana
Pisa
Italy
Policlinico Universitario Agostino Gemelli
Rome
Italy
Wojewodzki Szpital Specjalistyczny
Biała Podlaska
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Poland
Pratia Onkologia Katowice
Katowice
Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce
Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin
Poland
Dolnoslaskie Centrum Onkologii
Wroclaw
Poland
Seoul National University Hospital
Seoul
South Korea
Severance Hospital Yonsei University Health System
Seoul
South Korea
Asan Medical Center
Seoul
South Korea
+ 13 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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