Dienstag, 7. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
MonumenTAL-6

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

Rekrutierend

NCT-Nummer:
NCT06208150

Studienbeginn:
Januar 2024

Letztes Update:
25.04.2024

Wirkstoff:
Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone, Bortezomib

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

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

Kontakt

Studienlocations
(3 von 84)

Darmzentrum Klinikum Augsburg
Stenglinstraße 2
86156 Augsburg
DeutschlandRekrutierend» Google-Maps
Universitaetsklinikum Halle (Saale)
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Klinikum rechts der Isar der TU Muenchen
81675 München
(Bayern)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
St. Vincent's Hospital
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
St. Vincent's Hospital Melbourne
3065 Fitzroy
AustraliaRekrutierend» Google-Maps
Gold Coast University Hospital
4215 Southport
AustraliaRekrutierend» Google-Maps
Grand Hopital de Charleroi, site Notre Dame
6000 Charleroi
BelgiumRekrutierend» Google-Maps
AZ Nikolaas - Campus Sint-Niklaas Moerland
9100 Sint-Niklaas
BelgiumRekrutierend» Google-Maps
University Health Network (UHN) Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
H1T 2M4 Montreal
CanadaRekrutierend» Google-Maps
Peking University People s Hospital
100044 Beijing
ChinaRekrutierend» Google-Maps
Fakultni nemocnice Brno
625 00 Brno - Bohunice
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Hradec Kralove
500 05 Hradec Kralove
CzechiaRekrutierend» Google-Maps
CHU de Limoges Hopital Dupuytren
87042 Limoges
FranceRekrutierend» Google-Maps
CHU de Bordeaux - Hospital Haut-Leveque
33604 Pessac Cedex
FranceRekrutierend» Google-Maps
Institut Universitaire du Cancer Toulouse Oncopole
31100 Toulouse Cedex 9
FranceRekrutierend» Google-Maps
CHRU Tours Hopital Bretonneau
37044 TOURS Cedex 01
FranceRekrutierend» Google-Maps
Deenanath Mangeshkar Hospital and Research Centre
411004 Pune
IndiaRekrutierend» Google-Maps
Shamir Medical Center (Assaf Harofeh)
70300 Be'er Ya'akov
IsraelRekrutierend» Google-Maps
Rabin Medical center - Petah-Tikva
49100 Petah-Tikva
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center
64239 Tel Aviv-Yafo
IsraelRekrutierend» Google-Maps
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
15121 Alessandria
ItalyRekrutierend» Google-Maps
Asst Ovest Milanese - Ospedale Di Legnano
20025 Legnano
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Policlinico San Matteo
27100 Pavia
ItalyRekrutierend» Google-Maps
Juntendo University Hospital
113 8431 Bunkyo Ku
JapanRekrutierend» Google-Maps
Kanazawa University Hospital
920-8641 Kanazawa
JapanRekrutierend» Google-Maps
University Hospital Kyoto Prefectural University of Medicine
602-8566 Kyoto
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
Iwate Medical University Hospital
028-3695 Shiwa-gun
JapanRekrutierend» Google-Maps
Osaka University Hospital
565-0871 Suita-City
JapanRekrutierend» Google-Maps
Tottori University Hospital
683-0824 Tottori
JapanRekrutierend» Google-Maps
Kanagawa Cancer Center
241 8515 Yokohama City
JapanRekrutierend» Google-Maps
Dong-A University Hospital
49201 Busan
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Hospital
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Jeollanam-do
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ulsan University Hospital
44033 Ulsan
Korea, Republic ofRekrutierend» Google-Maps
St. Antonius Ziekenhuis Nieuwegein
3435 CM Nieuwegein
NetherlandsRekrutierend» Google-Maps
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
36-200 Brzozow
PolandRekrutierend» Google-Maps
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
25-734 Kielce
PolandRekrutierend» Google-Maps
Centrum Onkologii Ziemii Lubelskiej
20-090 Lublin
PolandRekrutierend» Google-Maps
Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
71-252 Szczecin
PolandRekrutierend» Google-Maps
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
52-007 Wroclaw
PolandRekrutierend» Google-Maps
Hosp. Univ. Virgen de Las Nieves
18014 Granada
SpainRekrutierend» Google-Maps
Hosp. Univ. Son Espases
07120 Palma de Mallorca
SpainRekrutierend» Google-Maps
Hosp. Clinico Univ. de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hosp. Clinico Univ. de Santiago
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
University Hospital of Wales
CF14 4HY Cardiff
United KingdomRekrutierend» Google-Maps
University Hospitals Plymouth NHS Trust
PL6 8DH Plymouth
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to compare the effectiveness of either talquetamab plus

pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide,

and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma

diagnosis according to the international myeloma working group (IMWG) diagnostic

criteria (b) measurable disease at screening as assessed by central laboratory,

defined by any of the following: (i) serum M-protein level greater than or equal to

(>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram

(mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein

in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10

milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio

- Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an

initial response to prior treatment, followed by confirmed progressive disease (PD) by

IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory

disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed

PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days

after cessation of treatment

- Documented evidence of PD or failure to achieve a minimal response to the last line of

therapy based on investigator's determination of response by IMWG criteria on or after

their last regimen

- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or

2 at screening and immediately prior to the start of administration of study treatment

- A participant must agree not to be pregnant, breastfeeding, or planning to become

pregnant while enrolled in this study or within 6months after the last dose of study

treatment

Exclusion Criteria:

- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to

any study drug or its excipients

- Stroke, transient ischemic attack, or seizure within 6 months prior to signing

informed consent form (ICF)

- Major surgery or had significant traumatic injury within 2 weeks prior to the start of

administration of study treatment, 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 or within 2 weeks after administration of the last dose of study treatment

- A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent

within 14-day period before the first dose of study drug

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

meningeal involvement of multiple myeloma. If either is suspected, negative whole

brain magnetic resonance imaging (MRI) and lumbar cytology are required

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) (Time Frame - Up to 6 years 5 months):
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.



Secondary outcome:

1. Overall Response Rate (ORR) (Time Frame - Up to 6 years 5 months):
ORR is defined as the percentage of participants with best overall response of partial response (PR) or better according to international myeloma working group (IMWG) response criteria.

2. Complete Response (CR) or Better Rate (Time Frame - Up to 6 years 5 months):
CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria.

3. Very Good Partial Response (VGPR) or Better Rate (Time Frame - Up to 6 years 5 months):
VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria.

4. Minimal Residual Disease (MRD)-negative CR Rate (Time Frame - Up to 6 years 5 months):
MRD-negative CR is defined as the percentage of participants who achieve both CR or better and MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy (SST).

5. Overall Survival (OS) (Time Frame - Up to 6 years 5 months):
OS is defined as the time from randomization to the date of participant's death.

6. Progression Free Survival on Next-line Therapy (PFS2) (Time Frame - Up to 6 years 5 months):
PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first.

7. Time to Next Treatment (TTNT) (Time Frame - Up to 6 years 5 months):
TTNT is defined as the time from randomization to the start of SST.

8. Serum Concentration of Talquetamab and Teclistamab (Time Frame - Up to 6 years 5 months):
Serum concentration of talquetamab and teclistamab will be reported.

9. Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab (Time Frame - Up to 6 years 5 months):
Number of participants with ADAs to talquetamab and teclistamab will be reported.

10. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) (Time Frame - Up to 6 years 5 months):
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.

11. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 (Time Frame - Up to 6 years 5 months):
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. EORTC-QLQ-C30 Version 3 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 or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("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 high scale score represents a higher response level.

12. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) (Time Frame - Up to 6 years 5 months):
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

13. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S) (Time Frame - Up to 6 years 5 months):
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."

14. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey (Time Frame - Up to 6 years 5 months):
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.

15. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q (Time Frame - Up to 6 years 5 months):
Change from baseline in symptoms, functioning, and HRQoL as assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.

16. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 (Time Frame - Up to 6 years 5 months):
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 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 or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("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 high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.

17. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L (Time Frame - Up to 6 years 5 months):
Change from baseline in symptoms, functioning, and HRQoL as assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

18. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S (Time Frame - Up to 6 years 5 months):
Change from baseline in symptoms, functioning, and HRQoL as assessed by PGI-S will be reported. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."

19. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey (Time Frame - Up to 6 years 5 months):
Change from baseline in symptoms, functioning, and HRQoL as assessed by epstein taste survey will be reported. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.

20. Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30 (Time Frame - Up to 6 years 5 months):
Percentage of participants with meaningful improvement in HRQol as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 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 or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("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 high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.

Studien-Arme

  • Experimental: Arm A: Talquetamab + Pomalidomide (Tal-P)
    Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Experimental: Arm B: Talquetamab + Teclistamab (Tal-Tec)
    Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Active Comparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)
    Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.

Geprüfte Regime

  • Talquetamab (JNJ-64407564 / Talvey / ):
    Talquetamab will be administered as a SC injection.
  • Pomalidomide (Pomalyst / Imnovid / ):
    Pomalidomide will be administered orally.
  • Teclistamab (JNJ-64007957 / Tecvayli / ):
    Teclistamab will be administered as a SC injection.
  • Elotuzumab (Empliciti):
    Elotuzumab will be administered intravenously.
  • Dexamethasone:
    Dexamethasone will be administered either orally or intravenously.
  • Bortezomib (Velcade):
    Bortezomib will be administered as a SC injection.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.