Clinical trial NCT06425991: A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Keywords: 1-3 prior lines
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-05-23
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab
timeFrame: Cycle 1 (28 days cycle): Predose to Day 7 postdose
measure: Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose
timeFrame: Cycle 1 (28 days cycle): Predose to Day 7 postdose
measure: Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1
timeFrame: Cycle 3 (28 days cycle): Day 1
Secondary outcomes:
measure: Number of Participants with Anti-drug Antibodies (ADAs)
timeFrame: Up to approximately 3 years
measure: Percentage of Participants With Complete Response (CR) or Better Response
timeFrame: Up to approximately 3 years
measure: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: Up to approximately 3 years
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to approximately 3 years
measure: Number of Participants with Abnormal Laboratory Results
timeFrame: Up to approximately 3 years
measure: Percentage of Participants With Overall Response (Partial Response [PR] or Better)
timeFrame: Up to approximately 3 years
measure: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Augusta
country: United States
facility: Augusta University- Georgia Cancer Center
state: Georgia
city: Indianapolis
country: United States
facility: St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health
state: Indiana
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Richmond
country: Australia
facility: Epworth Healthcare
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre University Health Network
state: Ontario
city: Lille
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Nantes Cedex 1
country: France
facility: CHU Nantes
city: Pessac Cedex
country: France
facility: CHU de Bordeaux - Hospital Haut-Leveque
city: Pierre-Benite
country: France
facility: CHU Lyon Sud
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospita Ein Kerem
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Ancona
country: Italy
facility: Ospedali Riuniti Di Ancona
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII Bergamo
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Pisa
country: Italy
facility: Ospedale Santa Chiara AO Universitaria Pisana
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Biala Podlaska
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: ICO L'Hospitalet - Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Pozuelo de Alarcon
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust Christie Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: