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JOURNAL ONKOLOGIE – STUDIE
MagnetisMM-7

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Rekrutierend

NCT-Nummer:
NCT05317416

Studienbeginn:
März 2022

Letztes Update:
30.04.2024

Wirkstoff:
Elranatamab, Lenalidomide

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 215)

Onkologisches Zentrum Universitätsklinikum Würzburg
Josef-Schneider-Straße 6
97080 Würzburg
DeutschlandRekrutierend» Google-Maps
Universitaetsklinikum Koeln
50937 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitätsmedizin Johannes Gutenberg Universität Mainz
55131 Mainz
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps
Gynäkologisches Tumorzentrum am Universitätsklinikum Leipzig
4103 Leipzig
DeutschlandNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Schleswig-Holstein Campus Kiel
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
12200 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
12203 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Chemnitz gGMbH
09116 Chemnitz
(Sachsen)
GermanyRekrutierend» Google-Maps
Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
DeutschlandRekrutierend» Google-Maps
Klinikum rechts der Isar der Technischen Universität München
81675 München
(Bayern)
GermanyRekrutierend» Google-Maps
Banner Gateway Medical Center
85234 Gilbert
United StatesNoch nicht rekrutierend» Google-Maps
Banner MD Anderson Cancer Center
85234 Gilbert
United StatesNoch nicht rekrutierend» Google-Maps
Ronald Reagan UCLA Medical Center
90095 Los Angeles
United StatesRekrutierend» Google-Maps
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
90095 Los Angeles
United StatesRekrutierend» Google-Maps
Georgetown University Medical Center
20007 Washington
United StatesNoch nicht rekrutierend» Google-Maps
Miami Cancer Institute at Baptist Health, Inc.
33176 Miami
United StatesNoch nicht rekrutierend» Google-Maps
Emory University Hospital Midtown
30308 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Emory University Hospital
30322 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Investigational Drug Service, Emory University Clinic
30322 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Winship Cancer Institute, Emory University
30322 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Alliance for Multispecialty Research, LLC
66204 Merriam
United StatesNoch nicht rekrutierend» Google-Maps
University of Michigan
48109 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
University Of Mississippi Medical Center
39213 Jackson
United StatesRekrutierend» Google-Maps
University of Mississippi Medical Center
39216 Jackson
United StatesRekrutierend» Google-Maps
OhioHealth Arthur G.H. Bing, MD, Cancer Center
43214 Columbus
United StatesRekrutierend» Google-Maps
OhioHealth Research Institute
43214 Columbus
United StatesRekrutierend» Google-Maps
OhioHealth Riverside Methodist Hospital
43214 Columbus
United StatesNoch nicht rekrutierend» Google-Maps
OhioHealth Riverside Methodist Hospital
43214 Columbus
United StatesRekrutierend» Google-Maps
Baylor University Medical Center
75246 Dallas
United StatesNoch nicht rekrutierend» Google-Maps
Baylor Scott & White Medical Center - Temple
76508 Temple
United StatesNoch nicht rekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Precision Haematology
3002 East Melbourne
AustraliaRekrutierend» Google-Maps
St Vincent's Hospital (Melbourne)
3065 Fitzroy
AustraliaRekrutierend» Google-Maps
Medizinische Universität Wien
1090 Vienna
AustriaRekrutierend» Google-Maps
Institut Jules Bordet
1070 Anderlecht
BelgiumNoch nicht rekrutierend» Google-Maps
Grand Hôpital de Charleroi
6000 Charleroi
BelgiumRekrutierend» Google-Maps
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
5530 Yvoir
BelgiumRekrutierend» Google-Maps
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
41253-190 Salvador,
BrazilRekrutierend» Google-Maps
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
90110-270 Porto Alegre
BrazilRekrutierend» Google-Maps
Centro de Pesquisa Clínica - Área Administrativa
90850-170 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital Mae de Deus
90880-480 Porto Alegre
BrazilRekrutierend» Google-Maps
Ambulatório de QT Convênio
17210-120 Jaú
BrazilRekrutierend» Google-Maps
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP
14051-140 Ribeirão Preto
BrazilRekrutierend» Google-Maps
BP - A Beneficencia Portuguesa de São Paulo
01321-001 Sao Paulo
BrazilRekrutierend» Google-Maps
Clínica Médica São Germano LTDA
04537-080 SP
BrazilRekrutierend» Google-Maps
Fundação Doutor Amaral Carvalho
17210-080 Jaú
BrazilRekrutierend» Google-Maps
Américas Medical City
22775-001 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Instituto de Educação, Pesquisa e Gestão em Saúde
22775001 Rio de Janeiro
BrazilRekrutierend» Google-Maps
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
01232-010 São Paulo
BrazilRekrutierend» Google-Maps
HU UNIFESP / SPDM - Hospital São Paulo
04024-002 São Paulo
BrazilRekrutierend» Google-Maps
Universidade Federal de Sao Paulo
04024-002 São Paulo
BrazilRekrutierend» Google-Maps
Hospital Japonês Santa Cruz
04122-000 São Paulo
BrazilRekrutierend» Google-Maps
Clínica Médica São Germano S/S Ltda
04537-080 São Paulo
BrazilRekrutierend» Google-Maps
Dr. Everett Chalmers Regional Hospital
E3B 5N5 Fredericton
CanadaRekrutierend» Google-Maps
Saint John Regional Hospital
E2L 4L2 Saint John
CanadaRekrutierend» Google-Maps
Hamilton Health Sciences Corporation
L8L 8E7 Hamilton
CanadaRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Windsor Regional Hospital Cancer Program
N8W 1L9 Windsor
CanadaNoch nicht rekrutierend» Google-Maps
Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
H1T 2M4 Montreal
CanadaRekrutierend» Google-Maps
McGill University Health Centre
H4A 3J1 Montreal
CanadaRekrutierend» Google-Maps
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSS
H4J 1C5 Montreal
CanadaRekrutierend» Google-Maps
Sun Yat-sen University Cancer Center
510060 Guangzhou
ChinaRekrutierend» Google-Maps
Tongji Hospital; Tongji Medical college; Huazhong University of Science and Technonogy
430030 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Institute of hematology&blood disease hospital
300020 Tianjin
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Wenzhou Medical University
325000 Wenzhou
ChinaRekrutierend» Google-Maps
Shanghai Fourth People's Hospital
200434 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Fakultní nemocnice Brno Bohunice
625 00 Brno
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Hradec Kralove
500 05 Hradec Kralove
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Ostrava
708 52 Ostrava-Poruba
CzechiaRekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze
12808 Praha 2
CzechiaRekrutierend» Google-Maps
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
00029 Helsinki
FinlandRekrutierend» Google-Maps
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
31100 Toulouse
FranceRekrutierend» Google-Maps
Hopital Claude Huriez - CHU de Lille
59000 Lille
FranceNoch nicht rekrutierend» Google-Maps
Pitie Salpetriere University Hospital
75013 Paris
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Poitiers
86021 Poitiers
FranceRekrutierend» Google-Maps
Chu Grenoble Alpes
38700 La Tronche
FranceNoch nicht rekrutierend» Google-Maps
Hopital Claude Huriez - CHU de Lille
59037 Lille
FranceRekrutierend» Google-Maps
Hôpital Saint Antoine
75571 Paris Cedex 12
FranceRekrutierend» Google-Maps
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
37032 Tours
FranceRekrutierend» Google-Maps
Hôpital Saint Antoine
75571 Paris
FranceNoch nicht rekrutierend» Google-Maps
Evangelismos General Hospital of Athens
106 76 Athens
GreeceRekrutierend» Google-Maps
Alexandra General Hospital of Athens
115 28 Athens
GreeceRekrutierend» Google-Maps
Theageneio Cancer Hospital of Thessaloniki
546 39 Thessaloniki
GreeceRekrutierend» Google-Maps
University Hospital of Ioannina
455 00 Ioannina
GreeceRekrutierend» Google-Maps
Somogy Megyei Kaposi Mór Oktató Kórház
7400 Kaposvár
HungaryAktiv, nicht rekrutierend» Google-Maps
Semmelweis University
1088 Budapest
HungaryAktiv, nicht rekrutierend» Google-Maps
Dél-Pesti Centrumkórház
1097 Budapest
HungaryAktiv, nicht rekrutierend» Google-Maps
Debreceni Egyetem Klinikai Kozpont
4032 Debrecen
HungaryAbgebrochen» Google-Maps
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
4400 Nyíregyháza
HungaryAktiv, nicht rekrutierend» Google-Maps
Medanta-The Medicity
122001 Gurugram
IndiaAktiv, nicht rekrutierend» Google-Maps
Fortis Memorial Research Institute
122002 Gurugram
IndiaAbgebrochen» Google-Maps
Christian Medical College Vellore
632517 Ranipet
IndiaRekrutierend» Google-Maps
Himalayan Institute Hospital Trust University
248140 Dehradun
IndiaAktiv, nicht rekrutierend» Google-Maps
Rajiv Gandhi Cancer Institute And Research Centre
110085 Delhi
IndiaAbgebrochen» Google-Maps
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Shaare Zedek Medical Center
9013102 Jerusalem
IsraelRekrutierend» Google-Maps
Hadassah Mount Scopus Medical Center
9124001 Jerusalem
IsraelRekrutierend» Google-Maps
Shaare Zedek Medical Center
9013102 Jerusalem
IsraelRekrutierend» Google-Maps
Shaare Zedek Medical Center
9103102 Jerusalem
IsraelRekrutierend» Google-Maps
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
47014 Meldola
ItalyRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli
00168 Roma
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
20122 Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Senese
53100 Siena
ItalyRekrutierend» Google-Maps
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
53100 Siena
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
60126 Ancona
ItalyRekrutierend» Google-Maps
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
40138 Bologna
ItalyRekrutierend» Google-Maps
Nagoya City University Hospital
467-8602 Nagoya
JapanRekrutierend» Google-Maps
Iwate Medical University Hospital
028-3695 Yahaba-cho, Shiwa-gun
JapanRekrutierend» Google-Maps
University Hospital,Kyoto Prefectural University of Medicine
602-8566 Kyoto-shi
JapanRekrutierend» Google-Maps
Hamamatsu University Hospital
431-3192 Hamamatsu-shi
JapanRekrutierend» Google-Maps
National Hospital Organization Kumamoto Medical Center
860-0008 Kumamoto
JapanRekrutierend» Google-Maps
University Hospital,Kyoto Prefectural University of Medicine
602-8566 Kyoto
JapanRekrutierend» Google-Maps
National Hospital Organization Okayama Medical Center
701-1192 Okayama
JapanRekrutierend» Google-Maps
Osaka Metropolitan University Hospital
545-8586 Osaka
JapanRekrutierend» Google-Maps
Japanese Red Cross Medical Center
150-8935 Tokyo
JapanRekrutierend» Google-Maps
Yamagata University Hospital
990-9585 Yamagata
JapanRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Namdong-gu
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Hwasun Gun
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Hospital
49241 Busan
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 Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic Univ. of Korea Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Kyungpook National University
41944 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Kyungpook National University Hospital
41944 Jung-gu
Korea, Republic ofRekrutierend» Google-Maps
Maastricht Universitair Medisch Centrum
6229 HX Maastricht
NetherlandsRekrutierend» Google-Maps
Oslo Universitetssykehus Ullevål
0450 Oslo
NorwayRekrutierend» Google-Maps
Stavanger Universitetssykehus
4011 Stavanger
NorwayRekrutierend» Google-Maps
Centrum Medyczne Pratia Poznań
60-185 Skorzewo
PolandAktiv, nicht rekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne,
80-214 Gdansk
PolandAktiv, nicht rekrutierend» Google-Maps
Uniwersytecki Szpital Kliniczny w Poznaniu
60-569 Poznan
PolandAktiv, nicht rekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
02-097 Warszawa
PolandAktiv, nicht rekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
02-781 Warszawa
PolandAktiv, nicht rekrutierend» Google-Maps
Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
50-367 Wroclaw
PolandAktiv, nicht rekrutierend» Google-Maps
Pratia Onkologia Katowice
40-519 Katowice
PolandAktiv, nicht rekrutierend» Google-Maps
Complejo Hospitalario Universitario de Santiago
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Institut Català d'Oncologia - L'Hospitalet
08908 L'Hospitalet Del Llobregat
SpainRekrutierend» Google-Maps
Hospital Universitari Mutua Terrassa
08221 Terrassa
SpainRekrutierend» Google-Maps
Institut Catala d' Oncologia. Hospital Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-Maps
Hospital Universitari Mutua Terrassa
08221 Terrassa
SpainRekrutierend» Google-Maps
Hospital Universitario de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Clínic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Quironsalud Madrid
28223 Pozuelo de Alarcon
SpainRekrutierend» Google-Maps
Clinica Universidad de Navarra
31008 Pamplona
SpainNoch nicht rekrutierend» Google-Maps
Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
17007 Gerona
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon
28007 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario HM Sanchinarro
28050 Madrid
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
SpainRekrutierend» Google-Maps
Karolinska Universitetssjukhuset Huddinge
141 86 Stockholm
SwedenRekrutierend» Google-Maps
Södra Älvsborgs Sjukhus Borås
501 82 Borås
SwedenRekrutierend» Google-Maps
Universitetssjukhuset Örebro
701 85 Örebro
SwedenRekrutierend» Google-Maps
Universitetssjukhuset i Linköping
581 85 Linköping
SwedenRekrutierend» Google-Maps
China Medical University Hospital
40447 Taichung
TaiwanRekrutierend» Google-Maps
Taichung Veterans General Hospital
407 Taichung
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital
11217 Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Medical Foundation-Linkou Branch
333 Taoyuan
TaiwanRekrutierend» Google-Maps
Medipol Mega Universite Hastanesi
34214 İstanbul
TurkeyAktiv, nicht rekrutierend» Google-Maps
Sisli Florence Nightingale Hastanesi
34381 İstanbul
TurkeyAbgebrochen» Google-Maps
Ege Universitesi Hastanesi
35100 Izmir
TurkeyAktiv, nicht rekrutierend» Google-Maps
Dokuz Eylul Universitesi Hastanesi
35340 İzmir
TurkeyRekrutierend» Google-Maps
Dokuz Eylul Universitesi Hastanesi
35340 İzmir
TurkeyAktiv, nicht rekrutierend» Google-Maps
Ankara Universitesi Tip Fakultesi Hastanesi
06100 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
06200 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Akdeniz Universitesi Hastanesi
07070 Antalya
TurkeyRekrutierend» Google-Maps
Aydın Adnan Menderes Universitesi Hastanesi
09100 Aydin
TurkeyAbgebrochen» Google-Maps
Erciyes Universitesi Tıp Fakultesi Hastaneleri
38030 Kayseri
TurkeyAbgebrochen» Google-Maps
Özel Anadolu Sağlık Merkezi
41400 Kocaeli
TurkeyAktiv, nicht rekrutierend» Google-Maps
The Beatson West of Scotland Cancer Centre
G12 0YN Glasgow
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and

BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable

disease at diagnosis

- Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD

positive

- History of induction therapy for newly diagnosed MM, followed by high dose therapy and

autologous stem cell transplant. Randomization must occur within 120 days from the

stem cell transplant. For participants who receive consolidation therapy after ASCT,

randomization must occur within 60 days of consolidation and within 7 months from

ASCT.

- Partial Response or better according to IMWG criteria at the time of randomization

- Must have an archival bone marrow aspirate sample(s) to identify the dominant

malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used

to track MRD status. This sample should preferably be collected before induction

treatment (eg, at diagnosis) or before transplant.

- ECOG performance status ≤1

- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1

- Not pregnant and willing to use contraception

Exclusion Criteria:

- Plasma cell leukemia

- Amyloidosis, Waldenström's macroglobulinemia

- POEMS syndrome

- Known active CNS involvement or clinical signs of myelomatous meningeal involvement

- Previous MM maintenance treatment

- Prior treatment with BCMA targeted therapy

- Any other active malignancy within 3 years prior to enrollment, except for adequately

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

- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited

to) HBV, HCV, and known HIV or AIDS-related illness

- Previous administration with an investigational drug or vaccine within 30 days (or as

determined by the local requirement) or 5 half-lives preceding the first dose of study

intervention used in this study (whichever is longer)

Studien-Rationale

Primary outcome:

1. Progression Free Survival (Time Frame - Assessed for up to approximately 5 years):
Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria



Secondary outcome:

1. Overall Survival (Time Frame - Assessed for up to approximately 5 years):
Defined as the time from randomization until death due to any cause

2. Minimal Residual Disease negativity rate (Time Frame - 12 months after randomization):
Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing

3. Sustained MRD negativity rate (Time Frame - 24 months after randomization):
Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing

4. Progression Free Survival (Time Frame - Assessed for up to approximately 5 years):
Progression Free Survival by investigator per IMWG response criteria

5. Overall minimal residual disease negativity rate (Time Frame - Assessed for up to approximately 5 years):
Minimal residual disease negativity rate per IMWG criteria

6. Duration of minimal residual disease negativity (Time Frame - Assessed for up to approximately 5 years):
Minimal residual disease negativity per IMWG criteria

7. Sustained minimal residual disease negativity rate (Time Frame - Assessed for up to approximately 5 years):
Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months

8. Complete response rate (Time Frame - Assessed for up to approximately 5 years):
Complete response rate by blinded independent central review and by investigator per IMWG criteria

9. Duration of complete response (Time Frame - Assessed for up to approximately 5 years):
Duration of complete response by blinded independent central review and by investigator per IMWG criteria

10. Frequency of adverse events (Time Frame - Up to 90 days after last dose):
Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention

11. Frequency of laboratory abnormalities (Time Frame - Assessed for up to approximately 5 years)

12. Pre-dose concentrations of elranatamab (Time Frame - Assessed for up to approximately 5 years):
Pharmacokinetics of elranatamab (trough concentrations of elranatamab)

13. Post-dose concentrations of elranatamab (Time Frame - Assessed for up to approximately 5 years):
Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"

14. Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab (Time Frame - Assessed for up to approximately 5 years):
Immunogenicity of elranatamab

15. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (Time Frame - Assessed for up to approximately 5 years):
Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms

16. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 (Time Frame - Assessed for up to approximately 5 years):
Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms

17. Progression Free Survival 2 (Time Frame - Assessed for up to approximately 5 years):
Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria

Studien-Arme

  • Experimental: Arm A - Part 1
    Elranatamab
  • Active Comparator: Arm B - Part 1
    Lenalidomide
  • Active Comparator: Arm B - Part 2
    Lenalidomide
  • Experimental: Arm C - Part 2
    Elranatamab

Geprüfte Regime

  • Elranatamab:
    BCMA-CD3 bispecific antibody
  • Lenalidomide:
    Immunomodulatory drug
  • Lenalidomide:
    Immunomodulatory drug
  • Elranatamab:
    BCMA-CD3 bispecific antibody

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant"

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