JOURNAL ONKOLOGIE – STUDIE
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell, Hematologic Neoplasms
Janssen Research & Development, LLC
Janssen Research & Development, LLC
E-Mail: JNJ.CT@sylogent.com» Kontaktdaten anzeigen
Studienlocations (3 von 71)
Germany» Google-MapsUniversitatsklinikum Freiburg
Germany» Google-MapsUniversitaetsklinikum Heidelberg
Germany» Google-MapsKlinikum Großhadern der Ludwig-Maximilians-Universität
Germany» Google-MapsOnkologisches Zentrum Universitätsklinikum Würzburg
Deutschland» Google-MapsUniversity of Alabama Birmingham
United States» Google-MapsThe University of Arizona Cancer Center
United States» Google-MapsUniversity of Arkansas for Medical Sciences
72205 Little Rock
United States» Google-MapsCity of Hope
United States» Google-MapsScripps Clinic
92037 La Jolla
United States» Google-MapsYale University School Of Medicine
06510 New Haven
United States» Google-MapsEmory University - Winship Cancer Institute
United States» Google-MapsUniversity of Chicago
United States» Google-MapsNorton Cancer Institute
United States» Google-MapsCenter for Cancer and Blood Disorders
United States» Google-MapsUniversity of Michigan Health System
48109 Ann Arbor
United States» Google-MapsHenry Ford Cancer Institute
United States» Google-MapsWashington University School of Medicine
63110 Saint Louis
United States» Google-MapsNorthwell Health
11042 Lake Success
United States» Google-MapsNYU Langone Health
10016 New York
United States» Google-MapsMount Sinai Medical Center
10023 New York
United States» Google-MapsUniversity of Rochester Medical Center
United States» Google-MapsMayo Clinic Rochester
United States» Google-MapsLevine Cancer Institute
United States» Google-MapsThe Ohio State University Wexner Medical Center - James Cancer Hospital
United States» Google-MapsProvidence Portland Medical Center
United States» Google-MapsSarah Cannon Research Institute
United States» Google-MapsUniversity of Texas, MD Anderson Cancer Center
United States» Google-MapsHuntsman Cancer Institute
84112 Salt Lake City
United States» Google-MapsSeattle Cancer Care Alliance
United States» Google-MapsUniversity of Wisconsin Carbone Cancer Center
United States» Google-MapsUCL - Saint Luc
Belgium» Google-MapsUZ Antwerpen
Belgium» Google-MapsUZ Leuven
Belgium» Google-MapsCHU de Liège - Domaine Universitaire du Sart Tilman
Belgium» Google-MapsCHU Henri Mondor
France» Google-MapsCHU de Montpellier, Hopital Saint-Eloi
France» Google-MapsC.H.U. Hotel Dieu - France
France» Google-MapsCHU de Bordeaux - Hôpital Haut-Lévêque
33604 Pessac cedex
France» Google-MapsCentre hospitalier Lyon-Sud
69495 Pierre Benite cedex
France» Google-MapsPôle IUC Oncopole CHU
31059 Toulouse cedex 9
France» Google-MapsRambam Medical Center
Israel» Google-MapsCarmel Medical Center
Israel» Google-MapsHadassah Medical Center
Israel» Google-MapsSheba Medical Center
52621 Ramat Gan
Israel» Google-MapsTel Aviv Sourasky Medical Center
64239 Tel Aviv
Israel» Google-MapsChonnam National University Hwasun Hospital
58128 Hwasun Gun
Korea, Republic of» Google-MapsSeverance Hospital, Yonsei University Health System
Korea, Republic of» Google-MapsSamsung Medical Center
Korea, Republic of» Google-MapsThe Catholic University of Korea Seoul St. Mary's Hospital
Korea, Republic of» Google-MapsSeoul National University Hospital
Korea, Republic of» Google-MapsAsan Medical Center
Korea, Republic of» Google-MapsVU Medisch Centrum
1081 HV Amsterdam
3584 CX Utrecht
Netherlands» Google-MapsUniwersyteckie Centrum Kliniczne
Poland» Google-MapsNarodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach
Poland» Google-MapsSzpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poland» Google-MapsNarodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Poland» Google-MapsUniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Poland» Google-MapsHosp. Univ. Germans Trias I Pujol
Spain» Google-MapsHosp. Univ. Vall D'Hebron
Spain» Google-MapsInst. Cat. Doncologia-H Duran I Reynals
Spain» Google-MapsHosp. Univ. Fund. Jimenez Diaz
Spain» Google-MapsHosp. Univ. 12 de Octubre
Spain» Google-MapsHosp. Univ. Virgen de La Arrixaca
Spain» Google-MapsClinica Univ. de Navarra
Spain» Google-MapsHosp. Quiron Madrid Pozuelo
28223 Pozuelo de Alarcon
Spain» Google-MapsHosp. Clinico Univ. de Salamanca
Spain» Google-MapsHosp. Univ. Marques de Valdecilla
Spain» Google-MapsHosp. Virgen Del Rocio
Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions,
increased susceptibility to infections, hypercalcemia, and renal failure. Talquetamab is a
humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed
to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule
found on T lymphocytes (T cell). This study consists 3 periods: screening phase (up to 28
days), treatment phase (start of study drug administration and continues until the completion
of the end of treatment [EOT (30 days (+ 7 days)] visit); and a post-treatment follow-up
phase (until the end of study unless the participant has died, is lost to follow up or has
withdrawn consent). Total duration of study is up to 2 years (after the last participant
receives their first dose). Safety, pharmacokinetics (PK), laboratory tests, and
questionnaire will be assessed at specified time points during this study. Participants
safety and study conduct will be monitored throughout the study. The corresponding study
(NCT03399799) is the Phase 1 part of the study and TALMMY1001- Part 3 is the Phase 2 part of
- Documented initial diagnosis of multiple myeloma according to international myeloma
working group (IMWG) diagnostic criteria
- Part 3: Measurable disease cohort A and cohort B: multiple myeloma must be measurable
by central laboratory assessment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Women of childbearing potential must have a negative pregnancy test at screening and
prior to the first dose of study drug using a highly sensitive pregnancy test either
serum (beta human chorionic gonadotropin [hCG]) or urine
- Willing and able to adhere to the prohibitions and restrictions specified in this
- Part 3 only: Cohort A only: exposed to a CAR-T or T cell redirection therapy at any
time. Cohort B: T cell redirection therapy within 3 months
- Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the
product manufacturer prior to the first dose, during treatment, or within 100 days of
the last dose of talquetamab
- Toxicities from previous anticancer therapies should have resolved to baseline levels
or to Grade 1 or less except for alopecia or peripheral neuropathy
- Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of
prednisone within the 14-day period before the first dose of study drug (does not
include pretreatment medication)
- Stroke or seizure within 6 months prior to signing the informed consent form (ICF)
1. Overall Response Rate (ORR) (Time Frame - Up to 15 months):
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.
1. Duration of Response (DOR) (Time Frame - Up to 2 years and 10 months):
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria.
2. Very Good Partial Response (VGPR) or Better Rate (Time Frame - Up to 2 years and 10 months):
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 years and 10 months):
CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.
4. Stringent Complete Response (sCR) Rate (Time Frame - Up to 2 years and 10 months):
sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.
5. Time to Response (TTR) (Time Frame - Up to 2 years and 10 months):
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 years and 10 months):
PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.
7. Overall Survival (OS) (Time Frame - Up to 2 years and 10 months):
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 years and 10 months):
MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on (intent to treat) ITT similar to the other response data.
9. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Time Frame - Up to 2 years and 10 months):
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 years and 10 months):
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, 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 years and 10 months):
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 Abnormalities in Clinical Laboratory Values (Time Frame - Up to 2 years and 10 months):
Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.
13. Serum Concentration of Talquetamab (Time Frame - Up to 2 years and 10 months):
Serum samples will be analyzed to determine concentrations of talquetamab.
14. Number of Participants with Talquetamab Antibodies (Time Frame - Up to 2 years and 10 months):
Antibodies to talquetamab 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 years and 10 months):
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 years and 10 months):
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 years and 10 months):
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 years and 10 months):
ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes.
- Experimental: Part 3: Cohort A (Talquetamab)
Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
- Experimental: Part 3: Cohort B (Talquetamab)
Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
- Talquetamab (JNJ-64407564):
Talquetamab will be administered SC until disease progression.