Trial Title:
A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT06425991
Condition:
Relapsed or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
1-3 prior lines
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Teclistamab
Description:
Teclistamab will be administered subcutaneously.
Arm group label:
Arm A: Pre-change Teclistamab
Arm group label:
Arm B: Post-change Teclistamab
Other name:
JNJ-64007957
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Florida
Address:
City:
Weston
Zip:
33331
Country:
United States
Status:
Recruiting
Facility:
Name:
Augusta University- Georgia Cancer Center
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Facility:
Name:
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health
Address:
City:
Indianapolis
Zip:
46237
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
Baylor University Medical Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
Box Hill Hospital
Address:
City:
Box Hill
Zip:
3128
Country:
Australia
Status:
Recruiting
Facility:
Name:
Royal Prince Alfred Hospital
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Epworth Healthcare
Address:
City:
Richmond
Zip:
3121
Country:
Australia
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre University Health Network
Address:
City:
Toronto
Zip:
M5G 1X6
Country:
Canada
Status:
Recruiting
Facility:
Name:
CHRU de Lille Hopital Claude Huriez
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Nantes
Address:
City:
Nantes Cedex 1
Zip:
44093
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Bordeaux - Hospital Haut-Leveque
Address:
City:
Pessac Cedex
Zip:
33604
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Lyon Sud
Address:
City:
Pierre-Benite
Zip:
69495
Country:
France
Status:
Recruiting
Facility:
Name:
Klinikum Chemnitz gGmbH
Address:
City:
Chemnitz
Zip:
09113
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Hamburg Eppendorf
Address:
City:
Hamburg
Zip:
20251
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Wurzburg
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Facility:
Name:
Ospedali Riuniti Di Ancona
Address:
City:
Ancona
Zip:
60126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Santa Chiara AO Universitaria Pisana
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Policlinico Universitario Agostino Gemelli
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea Seoul St Mary s Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Wojewodzki Szpital Specjalistyczny
Address:
City:
Biala Podlaska
Zip:
21 500
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Facility:
Name:
Pratia Onkologia Katowice
Address:
City:
Katowice
Zip:
40 519
Country:
Poland
Status:
Recruiting
Facility:
Name:
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Address:
City:
Kielce
Zip:
25-734
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Address:
City:
Lublin
Zip:
20-090
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hosp Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
ICO L'Hospitalet - Hospital Duran i Reynals
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Univ. de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Quiron Madrid Pozuelo
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Clinico Univ de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hammersmith Hospital
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie NHS Foundation Trust Christie Hospital
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Norfolk & Norwich University Hospital
Address:
City:
Norwich
Zip:
NR4 7UY
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Derriford Hospital
Address:
City:
Plymouth
Zip:
PL6 8DH
Country:
United Kingdom
Status:
Recruiting
Start date:
June 7, 2024
Completion date:
January 2, 2027
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06425991
