A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant (MagnetisMM-6)

AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED 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. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed 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 rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab; Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Bortezomib

• Study Type: Interventional
• Enrollment (Estimated): 1116
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Australia
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Recruiting
      • Pindara Private Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Recruiting
      • St Vincent's Hospital Melbourne
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, 3002
      • Recruiting
      • Epworth Freemasons
    • Richmond, Victoria, Australia, 3121
      • Recruiting
      • Epworth Healthcare
• Austria
  • Salzburg, Austria, 5020
    • Not yet recruiting
    • Uniklinikum Salzburg
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Not yet recruiting
      • Cross Cancer Institute
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Not yet recruiting
      • Dr. Everett Chalmers Regional Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • QEII Health Sciences Centre
    • Halifax, Nova Scotia, Canada, B3S 0H6
      • Recruiting
      • Nova Scotia Health Authority
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100091
      • Recruiting
      • Peking University Third Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Southern medical university Nanfang hospital
    • Guangzhou, Guangdong, China, 510555
      • Recruiting
      • Sun yat-sen University Cancer Center
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • the First Affiliated Hospital of Soochow University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200434
      • Recruiting
      • Tongji University - Shanghai Fourth People's Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Recruiting
      • Institute of hematology&blood disease hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• Czechia
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Fakultni nemocnice Olomouc
  • Prague, Czechia, 12808
    • Recruiting
    • Vseobecna fakultni nemocnice v Praze
  • Brno-město
    • Brno, Brno-město, Czechia, 625 00
      • Recruiting
      • Fakultní nemocnice Brno Bohunice
• Finland
  • Helsinki, Finland, 00029
    • Recruiting
    • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
  • Oulu, Finland, 90220
    • Recruiting
    • Oulu University Hospital
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Recruiting
      • Turku University Hospital
• France
  • Nantes, France, 44093 Cedex 1
    • Recruiting
    • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
  • Paris, France, 75012
    • Not yet recruiting
    • Hôpital Saint Antoine
  • Alpes-maritimes
    • Nice, Alpes-maritimes, France, 06200
      • Not yet recruiting
      • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
  • Haute-garonne
    • Toulouse, Haute-garonne, France, 31100
      • Recruiting
      • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
  • Vienne
    • Poitiers, Vienne, France, 86021
      • Recruiting
      • Centre Hospitalier Universitaire de Poitiers
• Germany
  • Chemnitz, Germany, 09116
    • Recruiting
    • Klinikum Chemnitz
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Recruiting
      • Universitaetsklinikum Tuebingen
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Not yet recruiting
      • Universitätsmedizin Johannes Gutenberg Universität Mainz
• Greece
  • Athens, Greece, 10676
    • Recruiting
    • Evangelismos General Hospital of Athens
  • Attikí
    • Athens, Attikí, Greece, 106 76
      • Recruiting
      • Evangelismos General Hospital of Athens
    • Athens, Attikí, Greece, 115 28
      • Recruiting
      • Alexandra General Hospital of Athens
  • Kentrikí Makedonía
    • Thessaloniki, Kentrikí Makedonía, Greece, 540 07
      • Recruiting
      • "Theagenio" Cancer Hospital of Thessaloniki
  • Ípeiros
    • Ioannina, Ípeiros, Greece, 455 00
      • Recruiting
      • University Hospital of Ioannina
• Israel
  • Central District
    • Petah Tikva, Central District, Israel, 4910021
      • Recruiting
      • Rabin Medical Center
    • Ramat Gan, Central District, Israel, 5265601
      • Recruiting
      • The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9112001
      • Recruiting
      • Hadassah Medical Center
  • Southern District
    • Beersheba, Southern District, Israel, 8410101
      • Recruiting
      • Soroka Medical Center
  • TELL ABĪB
    • Tel Aviv, TELL ABĪB, Israel, 6423906
      • Recruiting
      • Sourasky Medical Center
• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • Milan, Italy, 20141
    • Recruiting
    • Istituto Europeo di Oncologia IRCCS
  • Pescara, Italy, 65124
    • Recruiting
    • ASL PESCARA-Presidio Ospedaliero Pescara
  • Pescara, Italy, 65124
    • Recruiting
    • Azienda Sanitaria Locale di Pescara
  • Roma, Italy, 00161
    • Recruiting
    • AOU Policlinico Umberto I
  • Emilia-Romagna
    • Meldola (Fc), Emilia-Romagna, Italy, 47014
      • Recruiting
      • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
    • Piacenza, Emilia-Romagna, Italy, 29121
      • Recruiting
      • AUSL di Piacenza
    • Ravenna, Emilia-Romagna, Italy, 48121
      • Recruiting
      • Ospedale Santa Maria delle Croci
  • FG
    • San Giovanni Rotondo, FG, Italy, 71013
      • Recruiting
      • IRCCS Casa Sollievo della Sofferenza
  • Friuli Venezia Giulia
    • Aviano, Friuli Venezia Giulia, Italy, 33081
      • Recruiting
      • Cro-Irccs
  • Lombardy
    • Monza, Lombardy, Italy, 20900
      • Recruiting
      • Fondazione IRCCS San Gerardo dei Tintori
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • Recruiting
      • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
  • Sicily
    • Palermo, Sicily, Italy, 90127
      • Recruiting
      • A.O.U. Policlinico Paolo Giaccone
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • Recruiting
      • Azienda Ospedaliero Universitaria Pisana
• Japan
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Kyushu University Hospital
  • Okayama, Japan, 701-1192
    • Recruiting
    • National Hospital Organization Okayama Medical Center
  • Osaka, Japan, 545-0051
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Yamagata, Japan, 990-9585
    • Recruiting
    • Yamagata University Hospital
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1193
      • Recruiting
      • University of Fukui Hospital
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Recruiting
      • Gunma University Hospital
  • Iwate
    • Yahaba-cho, Iwate, Japan, 028-3695
      • Recruiting
      • Iwate Medical University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
  • Shizuoka
    • Nagaizumi-cho, Shizuoka, Japan, 411-8777
      • Recruiting
      • Shizuoka Cancer Center
  • Tokyo
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Recruiting
      • Japanese Red Cross Medical Center
• Netherlands
  • South Holland
    • Dordrecht, South Holland, Netherlands, 3318 AT
      • Recruiting
      • Albert Schweitzer Ziekenhuis, Locatie Dordwijk
• Poland
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
      • Active, not recruiting
      • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-214
      • Recruiting
      • Uniwersyteckie Centrum Kliniczne
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-519
      • Active, not recruiting
      • Pratia Onkologia Katowice
• South Korea
  • Jeonranamdo
    • Hwasun-gun, Jeonranamdo, South Korea, 58128
      • Recruiting
      • Chonnam National University Hwasun Hospital
  • Kyǒnggi-do
    • Seongnam, Kyǒnggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06591
      • Recruiting
      • The Catholic Univ. of Korea Seoul St. Mary's Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06591
      • Recruiting
      • The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
• Spain
  • Cáceres, Spain, 10003
    • Recruiting
    • Hospital San Pedro de Alcantara
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundación Jimenez Díaz
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital La Princesa
  • Málaga, Spain, 29010
    • Not yet recruiting
    • H.R.U Málaga - Hospital General
  • Valencia, Spain, 46026
    • Not yet recruiting
    • Hospital Universitari i Politecnic La Fe
  • A Coruña [LA Coruña]
    • Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
      • Recruiting
      • CHUS - Hospital Clinico Universitario
  • Barcelona [barcelona]
    • Badalona, Barcelona [barcelona], Spain, 08916
      • Recruiting
      • Institut Català d'Oncologia (ICO) - Badalona
    • L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain, 08908
      • Recruiting
      • Institut Català d'Oncologia - L'Hospitalet
    • Terrassa, Barcelona [barcelona], Spain, 08221
      • Not yet recruiting
      • Hospital Universitari Mutua Terrassa
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Not yet recruiting
      • Hospital Universitario Marqués de Valdecilla
  • Catalunya [cataluña]
    • Barcelona, Catalunya [cataluña], Spain, 08036
      • Recruiting
      • Hospital Clinic De Barcelona
  • Girona [gerona]
    • Girona, Girona [gerona], Spain, 17007
      • Recruiting
      • Institut Català d'Oncologia (ICO) - Girona
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28027
      • Recruiting
      • Clinica Universidad de Navarra
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Clinica Universidad de Navarra
  • València
    • Valencia, València, Spain, 46017
      • Recruiting
      • Hospital Universitario Doctor Peset
• Switzerland
  • Winterthur, Switzerland, 8401
    • Not yet recruiting
    • Kantonsspital Winterthur
• Taiwan
  • Taichung, Taiwan, 407
    • Recruiting
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 404332
    • Recruiting
    • China Medical University Hospital
  • Taipei, Taiwan, 10002
    • Active, not recruiting
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Medical Foundation-Linkou Branch
• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • MSK Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • MSK Monmouth
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • MSK Bergen
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • MSK Commack
    • Harrison, New York, United States, 10604
      • Recruiting
      • MSK Westchester
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center - Main Campus
    • New York, New York, United States, 10021
      • Recruiting
      • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center-Main Campus
    • Uniondale, New York, United States, 11553
      • Recruiting
      • MSK Nassau
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)

• Measurable disease based on IMWG criteria as defined by at least 1 of the following:

  • Serum M-protein ≥0.5 g/dL (Part 1) and ≥1 g/dL (Part 2);
  • Urinary M-protein excretion ≥200 mg/24 hours;
  • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
• Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.

• Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:

  • Participants not considered candidates for high-dose chemotherapy and ASCT due to age or
  • Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.
• ECOG performance status ≤2.
• Not pregnant and willing to use contraception
• For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.

Exclusion Criteria:

• Smoldering Multiple Myeloma.
• Monoclonal gammopathy of undetermined significance.
• Waldenströms Macroglobulinemia
• Plasma cell leukemia.
• Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited 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 for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
• For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
• For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening.
• Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
• Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide	Drug: Elranatamab; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Daratumumab; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Lenalidomide; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Experimental: Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide	Drug: Elranatamab; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Daratumumab; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Lenalidomide; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Experimental: Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide	Drug: Elranatamab; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Daratumumab; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Lenalidomide; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Experimental: Part 1: Elranatamab + Lenalidomide	Drug: Elranatamab; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Lenalidomide; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Active Comparator: Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + Dexamethasone	Drug: Daratumumab; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Lenalidomide; Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.; Drug: Dexamethasone; Randomized; Drug: Bortezomib; Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1 Dose Limiting Toxicity	From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide
Part 2: Progression free survival per IMWG	From randomization up to 97 months.
Part 2: Minimal Residual Disease negative CR rate	At 12 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		From date of randomization up to 97 months
PFS by investigator		From date of randomization up to 97 months
PFS2 by investigator (Part 2)		From the date of randomization up to 97 months
Objective Response Rate		From the date of randomization up to 97 months
Complete Response Rate		From the date of randomization up to 97 months
Time to Response		From the date of randomization to date of confirmed objective response up to 97 months
Duration of Response		From the date of confirmed objective response up to 97 months
Duration of Complete Response		From the date of confirmed complete response up to 97 months
Frequency of treatment-emergent adverse events		From the date of first dose of study intervention up to 97 months
Frequency of abnormal laboratory results		From the date of first dose of study intervention up to 97 months
Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations	Predose and post dose concentrations of elranatamab	From date of first dose of study intervention up to 97 months
Incidence of Anti-Drug Antibody against elranatamab	Immunogenicity of elranatamab	From date of first dose of study intervention up to 97 months
Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1)	Predose concentrations of daratumumab and lenalidomide	From date of first dose of study intervention up to 97 months
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2)	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 the symptom scales/items represent a greater presence of symptoms.	From date the informed consent is signed up to 97 months
Overall minimal residual disease negative CR rate		From date of randomization up to 97 months
Sustained MRD negative CR rate (Part 2)		From date of randomization up to 97 months
Duration of minimal residual disease negative CR (Part 2)		From date of minimal residual disease negative CR status up to 97 months
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma 20 (Part 2)	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	From date the informed consent is signed up to 97 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): October 18, 2030
• Study Completion (Estimated): October 3, 2033

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Multiple myeloma; Daratumumab; Lenalidomide; Bortezomib; PF-06863135; Elranatamab; B-Cell Maturation Antigen; MagnetisMM-6
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Polycyclic Compounds; Piperidines; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Bortezomib; Dexamethasone; daratumumab
• Other Study ID Numbers: C1071006; 2024-514139-50-00 (Registry Identifier: CTIS (EU)); MAGNETISMM-6 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes