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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
Active, not recruiting
CT.gov ID
NCT04649359
Collaborator
(none)
188
Enrollment
76
Locations
2
Arms
35.2
Anticipated Duration (Months)
2.5
Patients Per Site
0.1
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 Disease Intervention/Treatment Phase
  • Drug: Elranatamab (PF-06863135)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
188 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
Actual Primary Completion Date :
Jun 17, 2022
Anticipated Study Completion Date :
Jan 9, 2024

Arms and Interventions

Arm Intervention/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. complete response rate [assessed approximately every 4 weeks [up to approximately 2 years]]

    complete response rate (IMWG response criteria)

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

    duration of 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

Site City State Country Postal Code
1 Beverly Hills Cancer Center Beverly Hills California United States 90211
2 UCLA Hematology/Oncology Clinic Los Angeles California United States 90095
3 UCLA Ronald Reagan Medical Center Los Angeles California United States 90095
4 UC Irvine Health - Chao Family Comprehensive Cancer Center Orange California United States 92868-3201
5 Baptist Hospital of Miami Miami Florida United States 33176
6 Miami Cancer Institute Miami Florida United States 33176
7 Winship Cancer Institute @ Emory University Hospital Midtown Atlanta Georgia United States 30308
8 Emory University Hospital Atlanta Georgia United States 30322
9 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
10 Blood and Marrow Transplant Group of Georgia Atlanta Georgia United States 30342
11 Northside Hospital Atlanta Georgia United States 30342
12 Northwestern Medical Group Chicago Illinois United States 60611
13 Northwestern Memorial Hospital Chicago Illinois United States 60611
14 Loyola University Chicago performing research at Loyola University Medical Center Maywood Illinois United States 60153
15 Indiana Blood and Marrow Transplantation-Administrative Offices Indianapolis Indiana United States 46237
16 Indiana Blood and Marrow Transplantation-Clinic Indianapolis Indiana United States 46237
17 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
18 Norton Cancer Institute, St. Matthews Campus Louisville Kentucky United States 40207
19 Norton Women's and Children's Hospital Louisville Kentucky United States 40207
20 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
21 Massachusetts General Hospital Boston Massachusetts United States 02114
22 Hackensack University Medical Center Hackensack New Jersey United States 07601
23 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
24 Roswell Park Cancer Institute Buffalo New York United States 14263
25 Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care New York New York United States 10021
26 Weill Cornell Medical College - New York Presbyterian Hospital New York New York United States 10021
27 Weill Cornell Medical College - New York-Presbyterian Hospital New York New York United States 10021
28 Memorial Sloan Kettering Cancer Center New York New York United States 10065
29 Weill Cornell Medical College - New York Presbyterian Hospital New York New York United States 10065
30 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
31 St. Francis Hospital Greenville South Carolina United States 29601
32 Saint Francis Hospital Cancer Center Greenville South Carolina United States 29607
33 St Francis Eastside Greenville South Carolina United States 29615
34 Baylor University Medical Center Dallas Texas United States 75246
35 Epworth Healthcare East Melbourne Victoria Australia 3002
36 St Vincent's Hospital (Melbourne) Fitzroy Victoria Australia 3065
37 The Alfred Hospital Melbourne Victoria Australia 3004
38 Epworth Healthcare Richmond Victoria Australia 3050
39 ZNA-Middelheim Antwerpen Belgium 2020
40 ZNA Stuivenberg Antwerpen Belgium 2060
41 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
42 CHU UCL Namur site Godinne Yvoir Belgium 5530
43 Foothills Medical Centre Calgary Alberta Canada T2N 2T9
44 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
45 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
46 CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont Montreal Quebec Canada H1T 2M4
47 Jewish General Hospital Montreal Quebec Canada H3T 1E2
48 McGill University Health Centre - Glen Site Montreal Quebec Canada H4A 3J1
49 CHU de Lille - Hopital Claude Huriez Lille France 59037
50 CHU de Nantes - Hôtel Dieu Nantes Cedex 1 France 44093
51 Hôpital Saint-Antoine Paris Cedex 12 France 75571
52 Hopital Saint-Louis Paris France 75010
53 Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique Pierre Benite Cedex France 69495
54 CHU de Poitiers, Pôle Régional de Cancérologie Poitiers Cedex France 86021
55 Klinikum Chemnitz gGmbH Chemnitz Germany 09113
56 Universitätsklinikum Hamburg - Eppendorf Hamburg Germany 20246
57 Universitätsklinikum Heidelberg Heidelberg Germany 69120
58 Universitätsklinik Schleswig-Holstein Kiel Germany 24105
59 Nagoya City University Hospital Nagoya Aichi Japan 467-8602
60 Gunma University Hospital Maebashi Gunma Japan 371-8511
61 Kobe City Medical Center General Hospital Kobe-city Hyogo Japan 650-0047
62 Iwate Medical University Hospital Yahaba-cho, Shiwa-gun Iwate Japan 028-3695
63 Tohoku University Hospital Sendai Miyagi Japan 980-8574
64 Japanese Red Cross Medical Center Shibuya-ku Tokyo Japan 150-8935
65 Yamagata University Hospital Yamagata Japan 990-9585
66 Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Bydgoszcz Poland 85-168
67 Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu Poznan Poland 60-569
68 Uniwersytecki Szpital Kliniczny im.Jana Mikulicza -Radeckiego we Wroclawiu Wroclaw Poland 50-367
69 Complejo Hospitalario Universitario de Santiago Santiago de Compostela A Coruna Spain 15706
70 Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol Badalona Barcelona Spain 08916
71 Clinica Universitaria de Navarra Pamplona Navarra Spain 31008
72 Hospital Clinic de Barcelona Barcelona Spain 08036
73 Clinica Universitaria de Navarra Madrid Spain 28027
74 Hospital Universitario 12 de Octubre Madrid Spain 28041
75 Hospital Universitario Doctor Peset Valencia Spain 46017
76 The Christie NHS Foundation Trust Manchester United Kingdom M20 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:
Aug 4, 2022
Last Verified:
Aug 1, 2022
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
Myeloma
Multiple Myeloma
relapsed Multiple Myeloma
refractory Multiple Myeloma
PF-06863135
BCMA
bispecific
bispecific antibody
BCMA-CD3 bispecific
Elranatamab
MagnetisMM-3
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 4, 2022