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JOURNAL ONKOLOGIE – STUDIE

A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma

Rekrutierend

NCT-Nummer:
NCT04557098

Studienbeginn:
September 2020

Letztes Update:
21.05.2021

Wirkstoff:
Teclistamab

Indikation (Clinical Trials):
Multiple Myeloma, Hematologic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Kontakt

Studienlocations
(3 von 65)

Universitätsklinikum Carl-Gustav-Carus Dresden
01307 Dresden
(Sachsen)
GermanyZurückgezogen» Google-Maps
Universitaetsklinikum Hamburg Eppendorf
20246 Hamburg
(Hamburg)
GermanyZurückgezogen» Google-Maps
Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Koeln
50937 Koeln
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Universitatsklinikum Leipzig
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Onkologisches Zentrum Universitätsklinikum Würzburg
Josef-Schneider-Straße 6
97080 Würzburg
DeutschlandRekrutierend» Google-Maps
University of Alabama at Birmingham
35294 Birmingham
United StatesRekrutierend» Google-Maps
Mayo Clinic Cancer Center-Scottsdale
85054 Phoenix
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University of California, San Francisco
94143 San Francisco
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Stanford University Medical Center
94305-5623 Stanford
United StatesRekrutierend» Google-Maps
Mayo Clinic in Florida
32224 Jacksonville
United StatesZurückgezogen» Google-Maps
Winship Cancer Institute Emory University
30322 Atlanta
United StatesRekrutierend» Google-Maps
University of Kansas
66205 Westwood
United StatesZurückgezogen» Google-Maps
Dana-Farber Cancer Institute
02215-5418 Boston
United StatesZurückgezogen» Google-Maps
University of Michigan Comprehensive Cancer Center
48109 Ann Arbor
United StatesZurückgezogen» Google-Maps
Barbara Ann Karmanos Cancer Institute
48201 Detroit
United StatesRekrutierend» Google-Maps
Hackensack University Medical Center
07601 Hackensack
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Icahn School of Medicine at Mount Sinai
10029 New York
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Memorial Sloan-Kettering Cancer Center
10065 New York
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Mayo Clinic Cancer Center
55905 Rochester
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Levine Cancer Institute
28204 Charlotte
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Duke University Medical Center
27710 Durham
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The Ohio State University Wexner Medical Center - James Cancer Hospital
43210 Columbus
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University of Pennsylvania
19104 Philadelphia
United StatesRekrutierend» Google-Maps
University of Pittsburgh Medical Center
15232 Pittsburgh
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Vanderbilt - Ingram Cancer Center
37212 Nashville
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University of Texas Southwestern Medical Center
75390 Dallas
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Huntsman Cancer Institute
84112 Salt Lake City
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Fred Hutchinson Cancer Research Center
98109 Seattle
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Medical College Of Wisconsin
53226 Milwaukee
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Universitair Ziekenhuis Gent - UZ GENT
9000 Gent
BelgiumRekrutierend» Google-Maps
Universitaire Ziekenhuizen Leuven
3000 Leuven
BelgiumRekrutierend» Google-Maps
University Health Network (UHN) Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
McGill University Health Centre
H4A 3J1 Montreal
CanadaRekrutierend» Google-Maps
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
59000 Lille Cedex
FranceRekrutierend» Google-Maps
Centre Hospitalier Lyon Sud
69495 Pierre Benite
FranceRekrutierend» Google-Maps
Pôle IUC Oncopole CHU
31059 Toulouse cedex 9
FranceRekrutierend» Google-Maps
Azienda Ospedaliera Papa Giovanni XXIII
24127 Bergamo
ItalyRekrutierend» Google-Maps
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
10126 Turin
ItalyZurückgezogen» Google-Maps
Universitair Medisch Centrum Groningen
9713 GZ Groningen
NetherlandsZurückgezogen» Google-Maps
Hosp. Univ. Germans Trias I Pujol
08916 Badalona
SpainRekrutierend» Google-Maps
Hosp. Clinic I Provincial de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hosp. Quiron Madrid Pozuelo
28223 Pozuelo de Alarcon
SpainRekrutierend» Google-Maps
Hosp. Clinico Univ. de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hosp. Univ. Marques de Valdecilla
39008 Santander
SpainRekrutierend» Google-Maps
Sahlgrenska University Hospital
413 45 Göteborg
SwedenRekrutierend» Google-Maps
Haematology Centre, R 51
SE-141 86 Stockholm
SwedenRekrutierend» Google-Maps
University College Hospital
NW1 2PG London
United KingdomRekrutierend» Google-Maps
University Hospital Southampton
SO16 6YD Sothampton
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase

2 part of this study.

Ein-/Ausschlusskriterien

Inclusion Criteria: -

- Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

- Measurable disease: Multiple myeloma must be measurable by central laboratory

assessment

- Women of childbearing potential must have a negative pregnancy test at screening

- Willing and able to adhere to the prohibitions and restrictions specified in this

protocol

- Cohort A: received at least 3 prior MM treatment lines of therapy Prior therapy must

include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort B: received at least 4

prior MM treatment lines of therapies and whose disease is penta-refractory to at

least 2 PIs, at least 2 IMiDs, and an anti-CD38 monoclonal antibody; Cohort C:

received >= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38

monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with

CART-T cells or an antibody drug conjugate (ADC)

Exclusion Criteria:

- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary

amyloid light-chain amyloidosis

- The following medical conditions: Pulmonary compromise requiring supplemental oxygen

use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection,

hepatitis B or C infection, stroke or seizure less than or equal to (<=) 6 m,

autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial

Infarction <= 6 m, stage III-IV congestive heart failure, etc)

- Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part

3

- Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs

within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first

dose of study drug

- Toxicities from previous anticancer therapies that have not resolved to baseline or to

<= grade 1 (except for alopecia or peripheral neuropathy)

- Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone

within the 14-day period before the first dose of study drug (does not include

pretreatment medication)

- Known active central nervous system (CNS) involvement or exhibits clinical signs of

meningeal involvement of multiple myeloma (MM)

- Active malignancies with exceptions are: 1) Non-muscle invasive bladder cancer. 2)

Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is

considered completely cured. 3) Noninvasive cervical cancer treated within the last 24

months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5)

Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in

situ, or history of localized breast cancer and receiving antihormonal agents and

considered to have a very low risk of recurrence. 6) Malignancy that is considered

cured with minimal risk of recurrence

- Prior allogenic stem cell transplant <=6 months

- Prior autologous stem cell transplant <=12 weeks

- Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab

Studien-Rationale

Primary outcome:

1. Overall Response Rate (ORR) (Time Frame - Up to 2.9 years):
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.



Secondary outcome:

1. Duration of Response (DOR) (Time Frame - Up to 2.9 years):
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to PD, whichever occurs first.

2. Very Good Partial Response (VGPR) or Better Rate (Time Frame - Up to 2.9 years):
VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.

3. Complete Response (CR) or Better Rate (Time Frame - Up to 2.9 years):
CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.

4. Stringent Complete Response (sCR) Rate (Time Frame - Up to 2.9 years):
sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.

5. Time to Response (TTR) (Time Frame - Up to 2.9 years):
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.

6. Progression-free Survival (PFS) (Time Frame - Up to 2.9 years):
PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

7. Overall Survival (OS) (Time Frame - Up to 2.9 years):
OS is defined as the time from the date of first dose of study drug to the date of the participant's death.

8. Minimal Residual Disease (MRD) Negative Rate (Time Frame - Up to 2.9 years):
MRD-negative rate is defined as the proportion of participants who achieved MRD-negative status to a threshold of 10^-5 at any timepoint after initial dose of teclistamab and before disease progression or starting subsequent therapy

9. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Time Frame - Up to 2.9 years):
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

10. Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability (Time Frame - Up to 2.9 years):
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

11. Number of Participants with AEs by Severity (Time Frame - Up to 2.9 years):
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

12. Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values (Time Frame - Up to 2.9 years):
Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.

13. Serum Concentration of Teclistamab (Time Frame - Up to 3 months):
Serum concentrations of teclistamab will be reported.

14. Number of Participants with Teclistamab Antibodies (Time Frame - Up to 2.9 years):
Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.

15. Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30) (Time Frame - Baseline, up to 2.9 years):
The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

16. Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) (Time Frame - Baseline, up to 2.9 years):
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.

17. Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS) (Time Frame - Baseline, up to 2.9 years):
The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).

18. Overall Response Rate (ORR) in Participants with High-risk Molecular Features (Time Frame - Up to 2.9 years):
ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups (del17p, t(4;14), t(14;16), or other high-risk molecular subtypes).

Geprüfte Regime

  • Teclistamab (JNJ-64007957):
    Teclistamab will be administered SC.

Quelle: ClinicalTrials.gov


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