Trial Title:
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)
NCT ID:
NCT06152575
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Bortezomib
Pomalidomide
Elotuzumab
Conditions: Keywords:
Elranatamab
B-Cell Maturation Antigen
BCMA
Bispecific antibody
BCMA-CD3 bispecific antibody
Myeloma
Multiple myeloma
Relapsed multiple myeloma
Refractory multiple myeloma
MagnetisMM
MagnetisMM-32
Pomalidomide
Elotuzumab
Bortezomib
Carfilzomib
PF-06863135
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elranatamab
Description:
Elranatamab will be administered subcutaneously
Arm group label:
Elranatamab
Intervention type:
Drug
Intervention name:
Elotuzumab
Description:
Elotuzumab will be administered intravenously
Arm group label:
Investigator's Choice
Intervention type:
Drug
Intervention name:
Pomalidomide
Description:
Pomalidomide will be administered orally
Arm group label:
Investigator's Choice
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone will be administered orally
Arm group label:
Investigator's Choice
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
Bortezomib will be administered subcutaneously or intravenously
Arm group label:
Investigator's Choice
Intervention type:
Drug
Intervention name:
Carfilzomib
Description:
Carfilzomib will be administered intravenously
Arm group label:
Investigator's Choice
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Infirmary Cancer Care
Address:
City:
Mobile
Zip:
36607
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Beverly Hills Cancer Center
Address:
City:
Beverly Hills
Zip:
90211
Country:
United States
Status:
Recruiting
Facility:
Name:
Community Cancer Institute
Address:
City:
Clovis
Zip:
93611
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of California Davis (UC Davis) Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of California
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
UCHealth Harmony
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Status:
Recruiting
Facility:
Name:
Longs Peak Hospital
Address:
City:
Longmont
Zip:
80504
Country:
United States
Status:
Recruiting
Facility:
Name:
BRCR Global
Address:
City:
Plantation
Zip:
33322
Country:
United States
Status:
Recruiting
Facility:
Name:
BRCR Global
Address:
City:
Plantation
Zip:
33322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
BRCR Global - Tamarac
Address:
City:
Tamarac
Zip:
33321
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Ascentist Doctor Hospital
Address:
City:
Leawood
Zip:
66211
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Alliance for Multispecialty Research, LLC
Address:
City:
Merriam
Zip:
66204
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
O'Brien Pharmacy
Address:
City:
Mission
Zip:
66205
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Bryan Medical Center
Address:
City:
Lincoln
Zip:
68506-1299
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
NHO Revive Research Institute, LLC
Address:
City:
Lincoln
Zip:
68506
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
WMCHealth Advanced Physician Services
Address:
City:
Hawthorne
Zip:
10532
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Westchester Medical Center
Address:
City:
Valhalla
Zip:
10595
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
TriHealth Cancer Institute-Good Samaritan Hospital
Address:
City:
Cincinnati
Zip:
45220
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
St Francis Cancer Center
Address:
City:
Greenville
Zip:
29607
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Houston Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Houston Methodist Willowbrook Hospital
Address:
City:
Houston
Zip:
77070
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Houston Methodist Sugar Land Hospital
Address:
City:
Sugar Land
Zip:
77479
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Baylor Scott & White Medical Center - Temple
Address:
City:
Temple
Zip:
76508
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Wisconsin Clinical Science Center
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Facility:
Name:
Instituto Alexander Fleming
Address:
City:
Ciudad Autónoma de Buenos Aires
Zip:
C1426ANZ
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Hospital Universitario Austral
Address:
City:
Pilar
Zip:
1629
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Hospital Italiano de Buenos Aires
Address:
City:
Ciudad de Buenos Aires
Zip:
C1199ABB
Country:
Argentina
Status:
Not yet recruiting
Facility:
Name:
UZ Brussel
Address:
City:
Brussels
Zip:
1090
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Grand Hôpital de Charleroi
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
Address:
City:
Yvoir
Zip:
5530
Country:
Belgium
Status:
Recruiting
Facility:
Name:
UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Address:
City:
Porto Alegre
Zip:
90110-270
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Centro de Pesquisa Clínica - Área Administrativa
Address:
City:
Porto Alegre
Zip:
90850-170
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Mae de Deus
Address:
City:
Porto Alegre
Zip:
90880-480
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto de Educação, Pesquisa e Gestão em Saúde
Address:
City:
Rio de Janeiro
Zip:
20775-001
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Americas Centro de Oncologia Integrado
Address:
City:
Rio de Janeiro
Zip:
22775001
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Instituto de Educação, Pesquisa e Gestão em Saúde
Address:
City:
Rio de Janeiro
Zip:
22793-080
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
HU UNIFESP / SPDM - Hospital São Paulo
Address:
City:
São Paulo
Zip:
04024-002
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Universidade Federal de Sao Paulo
Address:
City:
São Paulo
Zip:
04024-002
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
The Moncton Hospital
Address:
City:
Moncton
Zip:
E1C 6Z8
Country:
Canada
Status:
Recruiting
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
Address:
City:
Montreal
Zip:
H4J 1C5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Fakultní nemocnice Brno Bohunice
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Kralovske Vinohrady
Address:
City:
Prague
Zip:
100 34
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Vseobecna fakultni nemocnice v Praze
Address:
City:
Praha 2
Zip:
12808
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Aarhus Universitetshospital, Skejby
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Aalborg Universitetshospital, Syd
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Tampereen yliopistollinen sairaala
Address:
City:
Tampere
Zip:
33520
Country:
Finland
Status:
Not yet recruiting
Facility:
Name:
Oulun yliopistollinen sairaala
Address:
City:
Oulu
Zip:
90220
Country:
Finland
Status:
Not yet recruiting
Facility:
Name:
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Address:
City:
Helsinki
Zip:
00029
Country:
Finland
Status:
Recruiting
Facility:
Name:
Turku University Hospital
Address:
City:
Turku
Zip:
20520
Country:
Finland
Status:
Not yet recruiting
Facility:
Name:
Hôpital NOVO
Address:
City:
Cergy Pontoise
Zip:
95303
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital NOVO
Address:
City:
Pontoise
Zip:
95300
Country:
France
Status:
Not yet recruiting
Facility:
Name:
CHD Vendee
Address:
City:
La Roche-sur-Yon
Zip:
85000
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Universitaire Necker Enfants Malades
Address:
City:
Paris
Zip:
75015
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hopitaux Universitaires Paris Centre-Hopital Cochin
Address:
City:
Paris
Zip:
75679
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier de Cornouaille
Address:
City:
Quimper
Zip:
29107
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Address:
City:
Tours
Zip:
37032
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Freiburg
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Ulm
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Facility:
Name:
Vivantes Klinikum Am Urban
Address:
City:
Berlin
Zip:
10249
Country:
Germany
Status:
Recruiting
Facility:
Name:
Vivantes Klinikum Am Urban
Address:
City:
Berlin
Zip:
10967
Country:
Germany
Status:
Recruiting
Facility:
Name:
Asklepios Altona
Address:
City:
Hamburg
Zip:
22763
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
St. Barbara-Klinik Hamm-Heessen
Address:
City:
Hamm
Zip:
59073
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Hospital of Alexandroupolis
Address:
City:
Alexandroupolis
Zip:
681 00
Country:
Greece
Status:
Not yet recruiting
Facility:
Name:
Evangelismos General Hospital of Athens
Address:
City:
Athens
Zip:
106 76
Country:
Greece
Status:
Not yet recruiting
Facility:
Name:
Alexandra General Hospital of Athens
Address:
City:
Athens
Zip:
115 28
Country:
Greece
Status:
Not yet recruiting
Facility:
Name:
"Theagenio" Cancer Hospital of Thessaloniki
Address:
City:
Thessaloniki
Zip:
540 07
Country:
Greece
Status:
Not yet recruiting
Facility:
Name:
University Hospital of Ioannina
Address:
City:
Ioannina
Zip:
455 00
Country:
Greece
Status:
Not yet recruiting
Facility:
Name:
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO
Address:
City:
Milano
Zip:
20153
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O.U. Policlinico Paolo Giaccone
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Istituto Europeo di Oncologia IRCCS
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Nagoya City University Hospital
Address:
City:
Nagoya
Zip:
467-8602
Country:
Japan
Status:
Recruiting
Facility:
Name:
Toyohashi Municipal Hospital
Address:
City:
Toyohashi
Zip:
441-8570
Country:
Japan
Status:
Recruiting
Facility:
Name:
Ehime Prefectural Central Hospital
Address:
City:
Matsuyama
Zip:
790-0024
Country:
Japan
Status:
Recruiting
Facility:
Name:
Gunma University Hospital
Address:
City:
Maebashi
Zip:
371-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Shibukawa Medical Center
Address:
City:
Shibukawa
Zip:
377-0280
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kobe City Medical Center General Hospital
Address:
City:
Kobe
Zip:
650-0047
Country:
Japan
Status:
Recruiting
Facility:
Name:
Iwate Medical University Hospital
Address:
City:
Shiwa-gun Yahaba-cho
Zip:
028-3695
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Nagaizumi-cho,Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
Nippon Medical School Hospital
Address:
City:
Bunkyo-ku
Zip:
113-8603
Country:
Japan
Status:
Recruiting
Facility:
Name:
Japanese Foundation for Cancer Research
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kagoshima University Hospital
Address:
City:
Kagoshima
Zip:
890-8520
Country:
Japan
Status:
Recruiting
Facility:
Name:
University Hospital,Kyoto Prefectural University of Medicine
Address:
City:
Kyoto
Zip:
602-8566
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Okayama Medical Center
Address:
City:
Okayama
Zip:
701-1192
Country:
Japan
Status:
Recruiting
Facility:
Name:
Okayama Rosai Hospital
Address:
City:
Okayama
Zip:
702-8055
Country:
Japan
Status:
Recruiting
Facility:
Name:
Yamagata University Hospital
Address:
City:
Yamagata
Zip:
990-9585
Country:
Japan
Status:
Recruiting
Facility:
Name:
Maastricht UMC+
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Address:
City:
Dordrecht
Zip:
3318 AT
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
St. Olavs Hospital
Address:
City:
Trondheim
Zip:
7030
Country:
Norway
Status:
Recruiting
Facility:
Name:
Sykehuset i Vestfold
Address:
City:
Tønsberg
Zip:
3103
Country:
Norway
Status:
Recruiting
Facility:
Name:
Institut Català d'Oncologia (ICO) - Badalona
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Cetir-Ascires
Address:
City:
Barcelona
Zip:
08029
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Mutua Terrassa
Address:
City:
Terrassa
Zip:
08221
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clínic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Català d'Oncologia (ICO) - Girona
Address:
City:
Girona
Zip:
17007
Country:
Spain
Status:
Recruiting
Facility:
Name:
ASCIRES ECG Médica S.L
Address:
City:
València
Zip:
46004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Centro de Diagnóstico y Resonancia Magnética
Address:
City:
Salamanca
Zip:
37004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari i Politecnic La Fe
Address:
City:
València
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Falu Lasarett
Address:
City:
Falun
Zip:
791 31
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Universitetssjukhuset Örebro
Address:
City:
Örebro
Zip:
701 85
Country:
Sweden
Status:
Recruiting
Facility:
Name:
St Bartholomew's Hospital
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Churchill Hospital
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Kent and Canterbury Hospital
Address:
City:
Canterbury
Zip:
CT1 3NG
Country:
United Kingdom
Status:
Recruiting
Start date:
February 8, 2024
Completion date:
March 24, 2028
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06152575
https://pmiform.com/clinical-trial-info-request?StudyID=C1071032
