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JOURNAL ONKOLOGIE – STUDIE

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Rekrutierend

NCT-Nummer:
NCT06152575

Studienbeginn:
Februar 2024

Letztes Update:
08.08.2024

Wirkstoff:
Elranatamab, Elotuzumab, Pomalidomide, Dexamethasone, Bortezomib, Carfilzomib

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Pfizer

Collaborator:
-

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com» Kontaktdaten anzeigen

Studienlocations
(3 von 74)

Universitaetsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Ulm
89081 Ulm
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Vivantes Klinikum Am Urban
10249 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Vivantes Klinikum Am Urban
10967 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
St. Barbara-Klinik Hamm-Heessen
59073 Hamm
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Beverly Hills Cancer Center
90211 Beverly Hills
United StatesRekrutierend» Google-Maps
Ascentist Doctor Hospital
66211 Leawood
United StatesNoch nicht rekrutierend» Google-Maps
Alliance for Multispecialty Research, LLC
66204 Merriam
United StatesNoch nicht rekrutierend» Google-Maps
O'Brien Pharmacy
66205 Mission
United StatesNoch nicht rekrutierend» Google-Maps
TriHealth Cancer Institute-Good Samaritan Hospital
45220 Cincinnati
United StatesNoch nicht rekrutierend» Google-Maps
Cleveland Clinic
44195 Cleveland
United StatesNoch nicht rekrutierend» Google-Maps
Instituto Alexander Fleming
C1426ANZ Ciudad Autónoma de Buenos Aires
ArgentinaNoch nicht rekrutierend» Google-Maps
Hospital Universitario Austral
1629 Pilar
ArgentinaNoch nicht rekrutierend» Google-Maps
Grand Hôpital de Charleroi
6000 Charleroi
BelgiumNoch nicht rekrutierend» Google-Maps
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
5530 Yvoir
BelgiumNoch nicht rekrutierend» Google-Maps
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
90110-270 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Centro de Pesquisa Clínica - Área Administrativa
90850-170 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Mae de Deus
90880-480 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
The Moncton Hospital
E1C 6Z8 Moncton
CanadaNoch nicht rekrutierend» Google-Maps
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
H4J 1C5 Montreal
CanadaRekrutierend» Google-Maps
Fakultni nemocnice Kralovske Vinohrady
100 34 Prague
CzechiaRekrutierend» Google-Maps
Tampereen yliopistollinen sairaala
33520 Tampere
FinlandNoch nicht rekrutierend» Google-Maps
Oulun yliopistollinen sairaala
90220 Oulu
FinlandNoch nicht rekrutierend» Google-Maps
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
00029 Helsinki
FinlandRekrutierend» Google-Maps
Hôpital NOVO
95303 Cergy Pontoise
FranceNoch nicht rekrutierend» Google-Maps
CHD Vendee
85000 La Roche-sur-Yon
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier de Cornouaille
29107 Quimper
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
37032 Tours
FranceNoch nicht rekrutierend» Google-Maps
University Hospital of Alexandroupolis
681 00 Alexandroupolis
GreeceNoch nicht rekrutierend» Google-Maps
Alexandra General Hospital of Athens
115 28 Athens
GreeceNoch nicht rekrutierend» Google-Maps
"Theagenio" Cancer Hospital of Thessaloniki
540 07 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
University Hospital of Ioannina
455 00 Ioannina
GreeceNoch nicht rekrutierend» Google-Maps
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
47014 Meldola
ItalyNoch nicht rekrutierend» Google-Maps
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO
20153 Milano
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. Policlinico Paolo Giaccone
90127 Palermo
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Careggi
50134 Firenze
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Europeo di Oncologia IRCCS
20141 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Nagoya City University Hospital
467-8602 Nagoya
JapanRekrutierend» Google-Maps
Toyohashi Municipal Hospital
441-8570 Toyohashi
JapanNoch nicht rekrutierend» Google-Maps
Ehime Prefectural Central Hospital
790-0024 Matsuyama
JapanRekrutierend» Google-Maps
Gunma University Hospital
371-8511 Maebashi
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Shibukawa Medical Center
377-0280 Shibukawa
JapanRekrutierend» Google-Maps
Kobe City Medical Center General Hospital
650-0047 Kobe
JapanNoch nicht rekrutierend» Google-Maps
Iwate Medical University Hospital
028-3695 Shiwa-gun Yahaba-cho
JapanNoch nicht rekrutierend» Google-Maps
Shizuoka Cancer Center
411-8777 Nagaizumi-cho,Sunto-gun
JapanNoch nicht rekrutierend» Google-Maps
Nippon Medical School Hospital
113-8603 Bunkyo-ku
JapanRekrutierend» Google-Maps
Japanese Foundation for Cancer Research
135-8550 Koto
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Koto
JapanRekrutierend» Google-Maps
Kagoshima University Hospital
890-8520 Kagoshima
JapanRekrutierend» Google-Maps
University Hospital,Kyoto Prefectural University of Medicine
602-8566 Kyoto
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Okayama Medical Center
701-1192 Okayama
JapanNoch nicht rekrutierend» Google-Maps
Okayama Rosai Hospital
702-8055 Okayama
JapanNoch nicht rekrutierend» Google-Maps
Yamagata University Hospital
990-9585 Yamagata
JapanRekrutierend» Google-Maps
Sykehuset i Vestfold
3103 Tønsberg
NorwayNoch nicht rekrutierend» Google-Maps
Institut Català d'Oncologia (ICO) - Badalona
08916 Badalona
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitari Mutua Terrassa
08221 Terrassa
SpainRekrutierend» Google-Maps
Hospital Clínic de Barcelona
08036 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
Institut Català d'Oncologia (ICO) - Girona
17007 Girona
SpainRekrutierend» Google-Maps
ASCIRES ECG Médica S.L
46004 València
SpainNoch nicht rekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon
28007 Madrid
SpainRekrutierend» Google-Maps
Centro de Diagnóstico y Resonancia Magnética
37004 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe
46026 València
SpainNoch nicht rekrutierend» Google-Maps
Universitetssjukhuset Örebro
701 85 Örebro
SwedenNoch nicht rekrutierend» Google-Maps
Churchill Hospital
OX3 7LE Oxford
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to learn about the study medicine called elranatamab.This

study aims to compare elranatamab to other medicines for the treatment of MM (a type of

cancer).

This study is seeking participants who:

- Are 18 years of age or older and have MM.

- Have received treatments before for MM.

- Have MM that has returned or not responded to their most recent treatment.

Half of the participants will receive elranatamab. The other half of participants will

receive a combination therapy selected by the study doctor. The selected combination

therapy will include 2 to 3 different medicines commonly used to treat MM.

Elranatamab will be given as a shot under the skin at the study clinic about once a week.

This may change to a smaller number of shots later in the study.

The medicines in the combination therapy will be taken by mouth (at home or at the study

clinic) AND will be given either as:

- a shot under the skin at the study clinic

- through a needle in the vein at the study clinic The number of times these medicines

will be taken depends on what combination therapy the study doctor selects.

Participants may continue to receive elranatamab or a combination therapy until their MM

is no longer responding. The study team will see how each participant is doing with the

study treatment during regular visits at the study clinic. The study team will continue

to follow-up with participants after study treatment with telephone contacts (or visits).

The study will compare the experiences of people receiving elranatamab to those people

receiving a combination therapy. This will help learn about the safety and how effective

elranatamab is.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Prior diagnosis of multiple myeloma as defined by International Myeloma Working

Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy

including prior anti-cluster of differentiation 38 (CD38) antibody and prior

lenalidomide.

- Documented evidence of progressive disease or failure to achieve a response to last

line of therapy per IMWG criteria.

- Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5

g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved

immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC

ratio (<0.26 or >1.65).

- Have clinical laboratory values within the specified range.

- ECOG (Eastern Cooperative Oncology Group) performance status ≤2.

- Not pregnant or breastfeeding and willing to use contraception.

Exclusion Criteria:

- Smoldering multiple myeloma.

- Plasma cell leukemia.

- Amyloidosis.

- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin

abnormalities (POEMS) syndrome.

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

meningeal involvement.

- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host

disease.

- Any active, uncontrolled bacterial, fungal, or viral infection.

- Any other active malignancy within 3 years prior to enrolment (exceptions include,

adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)

- Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or

CD3-redirecting therapy.

- Unable to receive investigator's choice therapy.

- Live attenuated vaccine within 4 weeks of the first dose of study intervention.

- Administration with an investigational product (e.g. drug or vaccine) within 30 days

preceding the first dose of study intervention used in this study.

Studien-Rationale

Primary outcome:

1. Progression free survival per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first



Secondary outcome:

1. Overall survival (Time Frame - Up to approximately 5 years):
From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first

2. Progression free survival on next-line treatment per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first

3. Objective response rate per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy

4. Duration of response per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first

5. Very good partial response or better response rate per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first

6. Complete response rate per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first

7. Duration of complete response per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first

8. Time to response per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of randomization to date of confirmed objective response

9. Minimal residual disease negativity rate per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first

10. Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first

11. Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria (Time Frame - Up to approximately 5 years):
From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first

12. Frequency of treatment-emergent adverse events (Time Frame - From date of first dose of study intervention up to 90 days after last study intervention administration)

13. Frequency of abnormal laboratory results (Time Frame - From date of first dose of study intervention up to 90 days after last study intervention administration)

14. Free elranatamab serum trough concentration [Ctrough] (Time Frame - From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab)

15. Elranatamab immunogenicity by anti-drug antibodies against elranatamab (Time Frame - From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab)

16. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (Time Frame - From date of informed consent up to approximately 35 days after last administration of study intervention):
Change from baseline scores

17. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 (Time Frame - From date of informed consent up to approximately 35 days after last administration of study intervention):
Change from baseline scores

Studien-Arme

  • Experimental: Elranatamab
    Participants will receive elranatamab monotherapy
  • Active Comparator: Investigator's Choice
    Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)

Geprüfte Regime

  • Elranatamab:
    Elranatamab will be administered subcutaneously
  • Elotuzumab:
    Elotuzumab will be administered intravenously
  • Pomalidomide:
    Pomalidomide will be administered orally
  • Dexamethasone:
    Dexamethasone will be administered orally
  • Bortezomib:
    Bortezomib will be administered subcutaneously or intravenously
  • Carfilzomib:
    Carfilzomib will be administered intravenously

Quelle: ClinicalTrials.gov


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