MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04649359
Collaborator
(none)
150
Enrollment
97
Locations
2
Arms
35.2
Anticipated Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Elranatamab (PF-06863135)
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
Actual Study Start Date :
Feb 2, 2021
Anticipated Primary Completion Date :
Sep 16, 2022
Anticipated Study Completion Date :
Jan 9, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Elranatamab (cohort A)

BCMA-CD3 bispecific antibody

Drug: Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody

Experimental: Elranatamab (cohort B)

BCMA-CD3 bispecific antibody

Drug: Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody

Outcome Measures

Primary Outcome Measures

  1. objective response rate [assessed approximately every 4 weeks [up to approximately 2 years]]

    objective response rate (IMWG response criteria)

Secondary Outcome Measures

  1. duration of response [assessed approximately every 4 weeks [up to approximately 2 years]]

    duration of response (IMWG response criteria)

  2. cumulative complete response rate [assessed approximately every 4 weeks [up to approximately 2 years]]

    cumulative complete response rate (IMWG response criteria)

  3. duration of cumulative complete response [assessed approximately every 4 weeks [up to approximately 2 years]]

    duration of cumulative complete response (IMWG response criteria)

  4. progression free survival [assessed approximately every 4 weeks [up to approximately 2 years]]

    progression free survival (IMWG response criteria)

  5. time to response [assessed approximately every 4 weeks [up to approximately 2 years]]

    time to response (IMWG response criteria)

  6. minimal residual disease negativity rate [assessed approximately every 12 months [up to approximately 2 years]]

    minimal residual disease negativity rate (IMWG response criteria)

  7. frequency of treatment-emergent adverse events [up to approximately 2 years]

    type and severity (including severity per NCI CTCAE v5)

  8. frequency of laboratory abnormalities [assessed at least approximately every cycle [each cycle approximately 28 days]]

    complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)

  9. concentrations of elranatamab (PF-06863135) [assessed approximately every 1 to 3 cycles [each cycle approximately 28 days]]

    pharmacokinetics of elranatamab

  10. immunogenicity of elranatamab (PF-06863135) [assessed approximately every 1 to 3 cycles [each cycle approximately 28 days]]

    immunogenicity of elranatamab (anti-drug antibodies against elranatamab)

  11. overall survival [at least approximately 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

  • Measurable disease, as defined by at least 1 of the following:

  1. Serum M-protein >0.5 g/dL by SPEP

  2. Urinary M-protein excretion >200 mg/24 hours by UPEP

  3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio

  • Refractory to at least one IMiD

  • Refractory to at least one PI

  • Refractory to at least one anti-CD38 antibody

  • Relapsed/refractory to last anti-myeloma regimen

  • Cohort A: has not received prior BCMA-directed therapy

  • Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)

  • ECOG performance status ≤2

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

  • Not pregnant and willing to use contraception

Exclusion Criteria:
  • Smoldering multiple myeloma

  • Active Plasma cell leukemia

  • Amyloidosis

  • POEMS syndrome

  • Stem cell transplant within 12 weeks prior to enrollment

  • Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection

  • 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.

  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Beverly Hills Cancer CenterBeverly HillsCaliforniaUnited States90211
2UCSD Medical Center - EncinitasEncinitasCaliforniaUnited States92024
3UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)La JollaCaliforniaUnited States92037
4UC San Diego Moores Cancer CenterLa JollaCaliforniaUnited States92093
5UCLA Hematology/Oncology ClinicLos AngelesCaliforniaUnited States90095
6UCLA Ronald Reagan Medical CenterLos AngelesCaliforniaUnited States90095
7UC Irvine Health - Chao Family Comprehensive Cancer CenterOrangeCaliforniaUnited States92868-3201
8UC San Diego Medical Center - HillcrestSan DiegoCaliforniaUnited States92103
9UCSD Medical Center - VistaVistaCaliforniaUnited States92081
10Baptist Hospital of MiamiMiamiFloridaUnited States33176
11Miami Cancer InstituteMiamiFloridaUnited States33176
12Winship Cancer Institute @ Emory University Hospital MidtownAtlantaGeorgiaUnited States30308
13Emory University HospitalAtlantaGeorgiaUnited States30322
14Winship Cancer Institute, Emory UniversityAtlantaGeorgiaUnited States30322
15Blood and Marrow Transplant Group of GeorgiaAtlantaGeorgiaUnited States30342
16Northside HospitalAtlantaGeorgiaUnited States30342
17Northwestern Medical GroupChicagoIllinoisUnited States60611
18Northwestern Memorial HospitalChicagoIllinoisUnited States60611
19Loyola University Chicago performing research at Loyola University Medical CenterMaywoodIllinoisUnited States60153
20Indiana Blood and Marrow Transplantation-Administrative OfficesIndianapolisIndianaUnited States46237
21Indiana Blood and Marrow Transplantation-ClinicIndianapolisIndianaUnited States46237
22University of Iowa Hospitals and ClinicsIowa CityIowaUnited States52242
23Norton Cancer Institute, St. Matthews CampusLouisvilleKentuckyUnited States40207
24Norton Women's and Children's HospitalLouisvilleKentuckyUnited States40207
25Ochsner Medical Center - Jefferson HighwayNew OrleansLouisianaUnited States70121
26Massachusetts General HospitalBostonMassachusettsUnited States02114
27Hackensack University Medical CenterHackensackNew JerseyUnited States07601
28John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew JerseyUnited States07601
29Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263
30Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer CareNew YorkNew YorkUnited States10021
31Weill Cornell Medical College - New York Presbyterian HospitalNew YorkNew YorkUnited States10021
32Weill Cornell Medical College - New York-Presbyterian HospitalNew YorkNew YorkUnited States10021
33Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
34Weill Cornell Medical College - New York Presbyterian HospitalNew YorkNew YorkUnited States10065
35Fox Chase Cancer CenterPhiladelphiaPennsylvaniaUnited States19111
36Prisma Health Cancer InstituteBoiling SpringsSouth CarolinaUnited States29316
37Prisma Health Cancer InstituteEasleySouth CarolinaUnited States29640
38St. Francis HospitalGreenvilleSouth CarolinaUnited States29601
39Prisma Health Cancer InstituteGreenvilleSouth CarolinaUnited States29605
40Saint Francis Hospital Cancer CenterGreenvilleSouth CarolinaUnited States29607
41Prisma Health Cancer InstituteGreenvilleSouth CarolinaUnited States29615
42St Francis EastsideGreenvilleSouth CarolinaUnited States29615
43Prisma Health Cancer InstituteGreerSouth CarolinaUnited States29650
44Prisma Health Cancer InstituteSenecaSouth CarolinaUnited States29672
45Baylor University Medical Center, Baylor Scott & WhiteDallasTexasUnited States75246
46Baylor University Medical CenterDallasTexasUnited States75246
47Epworth HealthcareEast MelbourneVictoriaAustralia3002
48St Vincent's Hospital (Melbourne)FitzroyVictoriaAustralia3065
49Barwon Health, University Hospital GeelongGeelongVictoriaAustralia3220
50The Alfred HospitalMelbourneVictoriaAustralia3004
51Epworth HealthcareRichmondVictoriaAustralia3050
52ZNA-MiddelheimAntwerpenBelgium2020
53ZNA StuivenbergAntwerpenBelgium2060
54Universitair Ziekenhuis AntwerpenEdegemBelgium2650
55CHU UCL Namur site GodinneYvoirBelgium5530
56Foothills Medical CentreCalgaryAlbertaCanadaT2N 2T9
57Tom Baker Cancer CentreCalgaryAlbertaCanadaT2N 4N2
58Cross Cancer InstituteEdmontonAlbertaCanadaT6G 1Z2
59University Health Network - Princess Margaret Cancer CentreTorontoOntarioCanadaM5G 2M9
60CIUSSS-EMTL, Installation Hopital Maisonneuve-RosemontMontrealQuebecCanadaH1T 2M4
61Jewish General HospitalMontrealQuebecCanadaH3T 1E2
62McGill University Health Centre - Glen SiteMontrealQuebecCanadaH4A 3J1
63CHU de Quebec - Université Laval - Hotel Dieu de QuebecQuébecQuebecCanadaG1R 2J6
64CHU de Lille - Hopital Claude HuriezLilleFrance59037
65CHU de Nantes - Hôtel DieuNantes Cedex 1France44093
66Hôpital Saint-AntoineParis Cedex 12France75571
67Hopital Saint-LouisParisFrance75010
68Centre Hospitalier Lyon Sud - Service d'Hematologie CliniquePierre Benite CedexFrance69495
69CHU de Poitiers, Pôle Régional de CancérologiePoitiers CedexFrance86021
70Klinikum Chemnitz gGmbHChemnitzGermany09113
71Universitätsklinikum Hamburg - EppendorfHamburgGermany20246
72Universitätsklinikum HeidelbergHeidelbergGermany69120
73Universitätsklinik Schleswig-HolsteinKielGermany24105
74Universitätsklinikum WürzburgWuerzburgGermany97080
75Universitätsklinikum WürzburgWürzburgGermany97080
76Nagoya City University HospitalNagoyaAichiJapan467-8602
77Gunma University HospitalMaebashiGunmaJapan371-8511
78Kobe City Medical Center General HospitalKobe-cityHyogoJapan650-0047
79Iwate Medical University HospitalYahaba-cho, Shiwa-gunIwateJapan028-3695
80Tohoku University HospitalSendaiMiyagiJapan980-8574
81Japanese Red Cross Medical CenterShibuya-kuTokyoJapan150-8935
82Yamagata University HospitalYamagataJapan990-9585
83Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyBydgoszczPoland85-168
84Szpital Kliniczny Przemienienia Pańskiego UM w PoznaniuPoznanPoland60-569
85Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we WroclawiuWroclawPoland50-367
86Complejo Hospitalario Universitario de SantiagoSantiago de CompostelaA CorunaSpain15706
87Institut Catala d' Oncologia. Hospital Universitari Germans Trias i PujolBadalonaBarcelonaSpain08916
88Hospital Universitario Quironsalud MadridPozuelo de AlarconMadridSpain28223
89Clinica Universitaria de NavarraPamplonaNavarraSpain31008
90Hospital Clinic de BarcelonaBarcelonaSpain08036
91Clinica Universitaria de NavarraMadridSpain28027
92Hospital Universitario 12 de OctubreMadridSpain28041
93Hospital Universitario de Salamanca - Complejo Asistencial Universitario de SalamancaSalamancaSpain37007
94Hospital Universitario Doctor PesetValenciaSpain46017
95Oxford University Hospitals NHS Foundation TrustOxfordOxfordshireUnited KingdomOX3 7LE
96The Royal Marsden NHS Foundation TrustSuttonSurreyUnited KingdomSM2 5PT
97The Christie NHS Foundation TrustManchesterUnited KingdomM20 4BX

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04649359
Other Study ID Numbers:
  • C1071003
  • 2020-004533-21
  • MagnetisMM-3
First Posted:
Dec 2, 2020
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021