A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- Registration Number
- NCT06425991
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Post-change Teclistamab Teclistamab Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Arm A: Pre-change Teclistamab Teclistamab Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.
- Primary Outcome Measures
Name Time Method 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.
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).
- Secondary Outcome Measures
Name Time Method Number of Participants with Anti-drug Antibodies (ADAs) Up to approximately 3 years Number of participants with ADAs to teclistamab will be reported.
Percentage of Participants With Complete Response (CR) or Better Response Up to approximately 3 years Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.
Number of Participants with Adverse Events (AEs) by Severity Up to approximately 3 years An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.
Number of Participants with Serious Adverse Events (SAEs) Up to approximately 3 years SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.
Number of Participants with Abnormal Laboratory Results Up to approximately 3 years Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.
Percentage of Participants With Overall Response (Partial Response [PR] or Better) Up to approximately 3 years Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria.
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response Up to approximately 3 years Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.
Trial Locations
- Locations (53)
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
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
CHU Nantes
🇫🇷Nantes Cedex 1, France
CHU de Bordeaux - Hospital Haut-Leveque
🇫🇷Pessac Cedex, France
CHU Lyon Sud
🇫🇷Pierre-Benite, 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
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Mary s Hospital
🇰🇷Seoul, Korea, Republic of
Wojewodzki Szpital Specjalistyczny
🇵🇱Biala 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
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
ICO L'Hospitalet - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Hosp. Quiron Madrid Pozuelo
🇪🇸Pozuelo de Alarcon, Spain
Hosp Clinico Univ de Salamanca
🇪🇸Salamanca, Spain
Hosp. Univ. Marques de Valdecilla
🇪🇸Santander, Spain
Hammersmith Hospital
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
🇬🇧Manchester, United Kingdom
Norfolk & Norwich University Hospital
🇬🇧Norwich, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom