A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

Last updated: January 30, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Myeloma

Bone Neoplasm

Lymphoproliferative Disorders

Treatment

Lenalidomide

Daratumumab

Elranatamab

Clinical Study ID

NCT05623020
C1071006
MAGNETISMM-6
2021-000803-20
2024-514139-50-00
  • Ages > 18
  • All Genders

Study Summary

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. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide or Elranatamab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with multiple myeloma.

There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide or elranatamab and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed transplant-ineligible multiple myeloma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al.,
  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:

  • Serum M-protein ≥0.5 g/dL;

  • Urinary M-protein excretion ≥200 mg/24 hours;

  • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa tolambda FLC ratio (<0.26 or >1.65).

  • Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who havereceived 1-2 prior lines of therapy including at least one immunomodulatory drug andone proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years ortransplant-ineligible as defined by age <65 years with comorbidities impacting thepossibility of transplant.

  • Part 2: participants with newly-diagnosed multiple myeloma that aretransplant-ineligible as defined by age ≥65 years or transplant-ineligible asdefined by age <65 years with comorbidities impacting the possibility of transplant

  • ECOG performance status ≤2.

  • Not pregnant and willing to use contraception

  • For participants with RRMM: Resolved acute effects of any prior therapy to baselineseverity or CTCAE Grade ≤1.

Exclusion

Exclusion Criteria:

  • Smoldering Multiple Myeloma.

  • Monoclonal gammopathy of undetermined significance.

  • Waldenströms Macroglobulinemia

  • Plasma cell leukemia.

  • Active, uncontrolled bacterial, fungal, or viral infection, including (but notlimited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.

  • Any other active malignancy within 3 years prior to enrollment, except foradequately treated basal cell or squamous cell skin cancer, carcinoma in situ, orStage 0/1 with minimal risk of recurrence per investigator.

  • For participants with RRMM: Previous treatment with a BCMA-directed therapy oranti-CD38-directed therapy within 6 months preceding the first dose of studyintervention in this study. Stem cell transplant ≤3 months prior to first dose ofstudy intervention or active GVHD.

  • For participants with NDMM: Previous systemic treatment for MM except for a shortcourse of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalentbefore the first dose of study intervention).

  • Live attenuated vaccine administered within 4 weeks of the first dose of studyintervention.

  • Administration of investigational product (eg, drug or vaccine) concurrent withstudy intervention or within 30 days (or as determined by the local requirement)preceding the first dose of study intervention used in this study.

Study Design

Total Participants: 966
Treatment Group(s): 4
Primary Treatment: Lenalidomide
Phase: 3
Study Start date:
November 10, 2022
Estimated Completion Date:
November 29, 2031

Connect with a study center

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Epworth Freemasons

    Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Epworth Hospital

    Richmond, Victoria 3121
    Australia

    Site Not Available

  • QEII Health Sciences Centre

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-město 625 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava, Moravskoslezský KRAJ 708 52
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12808
    Czechia

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

    Toulouse, Haute-garonne 31100
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne 86021
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, 44093 Cedex 1
    France

    Active - Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-württemberg 72076
    Germany

    Site Not Available

  • Klinikum Chemnitz

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Alexandra General Hospital of Athens

    Athens, Attikí 115 28
    Greece

    Active - Recruiting

  • Evangelismos General Hospital of Athens

    Athens, Attikí 106 76
    Greece

    Active - Recruiting

  • University Hospital of Ioannina

    Ioannina, Ípeiros 455 00
    Greece

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, Hadarom 8410101
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah-Tikva, Hamerkaz 4910021
    Israel

    Site Not Available

  • The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric

    Ramat Gan, Hamerkaz 5265601
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb 6423906
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, Yerushalayim 9112001
    Israel

    Active - Recruiting

  • AUSL di Piacenza

    Piacenza, Emilia-romagna 29121
    Italy

    Active - Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, Emilia-romagna 48121
    Italy

    Active - Recruiting

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, FG 71013
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardia 20900
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicilia 90127
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Toscana 56126
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia IRCCS

    Milano, 20141
    Italy

    Active - Recruiting

  • ASL PESCARA-Presidio Ospedaliero Pescara

    Pescara, 65124
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Site Not Available

  • University of Fukui Hospital

    Eiheiji-cho,Yoshida-gun, Fukui 910-1193
    Japan

    Site Not Available

  • University of Fukui Hospital

    Yoshida-gun, Fukui 910-1193
    Japan

    Site Not Available

  • Gunma University Hospital

    Maebashi, Gunma 371-8511
    Japan

    Site Not Available

  • Iwate Medical University Hospital

    Shiwa-gun Yahaba-cho, Iwate 028-3695
    Japan

    Site Not Available

  • Iwate Medical University Hospital

    Yahaba-cho, Iwate 028-3695
    Japan

    Active - Recruiting

  • Iwate Medical University Hospital

    Yahaba-cho, Shiwa-gun, Iwate 028-3695
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, Miyagi 980-8574
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo 150-8935
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, 545-0051
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Active - Recruiting

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    Korea, Republic of

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    Dordrecht, Zuid-holland 3318 AT
    Netherlands

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, Dolnośląskie 50-367
    Poland

    Site Not Available

  • MTZ Clinical Research Powered by Pratia

    Warszawa, Mazowieckie 02-127
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, Pomorskie 80-214
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Poznań

    Skorzewo, Wielkopolskie 60-185
    Poland

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice, Śląskie 40-519
    Poland

    Site Not Available

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [barcelona] 08916
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña] 08036
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - Girona

    Girona, Girona [gerona] 17007
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Madrid, Madrid, Comunidad DE 28027
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia, València 46017
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres, 10003
    Spain

    Active - Recruiting

  • Hospital La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 404332
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

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