A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by Pfizer
Sponsor
Pfizer
Information Provided by (Responsible Party)
Pfizer
Clinicaltrials.gov Identifier
NCT05020236
Other Study ID Numbers:
C1071005
First Submitted
August 10, 2021
First Posted
August 24, 2021
Last Update Posted
May 4, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Multiple Myeloma
Drug: ElranatamabDrug: ElranatamabDrug: ElranatamabDrug: DaratumumabDrug: ElranatamabDrug: Elranatamab

Study Design

Study TypeInterventional
Actual Enrollment944 participants
Design AllocationRandomized
Interventional ModelFactorial Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
Study Start DateOctober 3, 2021
Actual Primary Completion DateApril 26, 2026
Actual Study Completion Date1yr 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
Drug: Elranatamab
subcutaneous
Part 2 Randomized Arm A: Elranatamab
Drug: Elranatamab
subcutaneous
Part 2 Randomized Arm B: Elranatamab + Daratumumab
Drug: Elranatamab
subcutaneous
Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
Drug: Daratumumab
Daratumumab / hyaluronidase, subcutaneous
Part 3 Arm D: Elranatamab
Drug: Elranatamab
subcutaneous
Part 3 Arm E: Elranatamab + Daratumumab
Drug: Elranatamab
subcutaneous

Outcome Measures

Primary Outcome Measures
  1. Part 1 Safety Lead-In: Incidence of dose limiting toxicities
  2. Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
  3. Part 3: Frequency of treatment-emergent adverse events
Secondary Outcome Measures
  1. Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria
  2. Overall survival
  3. Objective response rate per International Myeloma Working Group criteria
  4. Duration of response per International Myeloma Working Group criteria
  5. Time to response per International Myeloma Working Group criteria
  6. Complete response rate per International Myeloma Working Group criteria
  7. Duration of complete response per International Myeloma Working Group criteria
  8. Minimal residual disease negativity rate per International Myeloma Working Group criteria
  9. Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
  10. Progression free survival on next-line treatment per International Myeloma Working Group criteria
  11. Frequency of treatment-emergent adverse events
  12. Frequency of abnormal laboratory results
  13. Rate of Grade ≥2 cytokine release syndrome
  14. Elranatamab pharmacokinetics by pre- and post-dose concentrations
  15. Elranatamab immunogenicity by anti-drug antibodies against elranatamab
  16. Daratumumab pharmacokinetics by pre-dose concentrations
  17. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
  18. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Prior diagnosis of multiple myeloma 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.
Urinary M-protein excretion ≥200 mg/24 hours.
Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
Prior anti-multiple myeloma therapy including treatment with lenalidomide.
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.
Plasma cell leukemia.
Amyloidosis.
POEMS Syndrome.
Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
Previous treatment with a BCMA-directed therapy.
Live attenuated vaccine within 4 weeks of the first dose of study intervention.
Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Contacts and Locations

Sponsors and CollaboratorsPfizer
Locations
Clovis Community Medical Center | Clovis California, United States, 93611Community Regional Medical Center | Fresno California, United States, 93721UCHealth Poudre Valley Hospital | Fort Collins Colorado, United States, 80524UCHealth Greeley Hospital | Greeley Colorado, United States, 80634Sylvester Comprehensive Cancer Center - Aventura | Aventura Florida, United States, 33180Sylvester Comprehensive Cancer Center - Coral Springs | Coral Springs Florida, United States, 33065University of Miami Hospital and Clinics - Deerfield Beach | Deerfield Beach Florida, United States, 33442Sylvester Comprehensive Cancer Center - Hollywood | Hollywood Florida, United States, 33021University of Miami Hospital and Clinics | Miami Florida, United States, 33136Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | New York New York, United States, 10021Memorial Sloan Kettering Cancer Center - Main Campus | New York New York, United States, 10065Hospital Universitario Austral | Presidente Derqui Buenos Aires, Argentina, B1629AHJPindara Private Hospital | Benowa Queensland, Australia, 4217QScan Radiology Clinics | Clayfield Queensland, Australia, 4011Gallipoli Medical Research Foundation | Greenslopes Queensland, Australia, 4120Slade Pharmacy | Richmond Victoria, Australia, 3121Linear Clinical Research | Perth Western Australia, Australia, 6009Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador | Salvador Estado de Bahia, Brazil, 41253-190Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa | Porto Alegre Rio Grande do Sul, Brazil, 90110-270Hospital Mae de Deus | Porto Alegre Rio Grande do Sul, Brazil, 90880-480Clínica Médica São Germano LTDA | SP São Paulo, Brazil, 04537-080Instituto de Educação, Pesquisa e Gestão em Saúde | Rio de Janeiro , Brazil, 22793-080HU UNIFESP / SPDM - Hospital São Paulo | São Paulo , Brazil, 04024-002Clínica Médica São Germano S/S Ltda | São Paulo , Brazil, 04537-080Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo , Brazil, 04543-000Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo , Brazil, 04544-000CIUSSS de l'Est-de-l'Île-de-Montréal | Montreal Quebec, Canada, H1T2M4Saskatoon Cancer Center | Saskatoon Saskatchewan, Canada, S7N4H4Fujian Medical University Union Hospital | Fuzhou Fujian, China, 350001Nanfang Hospital of Southern Medical University | Guangzhou Guangdong, China, 510515Sun Yat-sen University Cancer Center | Guangzhou Guangdong, China, 510555Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan Hubei, China, 430030Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School | Nanjing Jiangsu, China, 210008The Affiliated Hospital of Xuzhou Medical University | Xuzhou Jiangsu, China, 221006Shandong Provincial Hospital | Jinan Shandong, China, 250021Institute of hematology&blood disease hospital | Tianjin Tianjin Municipality, China, 301636Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing , China, 100730Chongqing University Cancer Hospital | Chongqing , China, 400030Fakultní nemocnice Brno Bohunice | Brno Brno-m?sto, Czechia, 625 00Fakultni Nemocnice Plzen | Plzen - Lochotin Plzeň Region, Czechia, 304 60Fakultni poliklinika | Prague Praha 2, Czechia, 120 00Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) | Helsinki , Finland, 00029Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren | Limoges Limousin, France, 87042Hôpital Saint Antoine | Paris , France, 75571Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique | Pierre-Bénite , France, 69495Charité Universitätsmedizin Berlin | Berlin , Germany, 12203Universitätsklinikum rechts der Isar, Technische Universität München (TUM) | München , Germany, 81675Alexandra General Hospital of Athens | Athens Attikí, Greece, 115 28Theageneio Cancer Hospital of Thessaloniki | Thessaloniki Kentrikí Makedonía, Greece, 546 39Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan Lombardy, Italy, 20122IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Bologna , Italy, 40138National Hospital Organization Shibukawa Medical Center | Shibukawa Gunma, Japan, 377-0280Tohoku University Hospital | Sendai Miyagi, Japan, 980-8574Akita University Hospital | Akita , Japan, 010-8543National Hospital Organization Kumamoto Medical Center | Kumamoto , Japan, 860-0008Nagasaki University Hospital | Nagasaki , Japan, 852-8501National Hospital Organization Okayama Medical Center | Okayama , Japan, 701-1192Yamagata University Hospital | Yamagata , Japan, 990-9585Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey Nuevo León, Mexico, 66460North Shore Hospital | Auckland , New Zealand, 0622Labtests Auckland Ltd. | Auckland , New Zealand, 1060Aotearoa Clinical Trials | Auckland , New Zealand, 2025Waikato District Health Board, Waikato Hospital | Hamilton , New Zealand, 3204Palmerston North Hospital | Roslyn , New Zealand, 4414Oslo Universitetssykehus Ullevål | Oslo , Norway, 0450St Olavs Hospital | Trondheim , Norway, 7030Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii | Bydgoszcz , Poland, 85-168Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan , Poland, 60-569Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw , Poland, 50-367Institut Català d'Oncologia - L'Hospitalet | L'Hospitalet Del Llobregat Barcelona [barcelona], Spain, 08908Hospital Universitari Mutua Terrassa | Terrassa Barcelona, Spain, 08221Clinica Universidad de Navarra | Pamplona Navarre, Spain, 31008Hospital Universitario de Toledo | Toledo Other, Spain, 45007Hospital Universitari Vall d'Hebron | Barcelona , Spain, 08035Hospital Universitari De Girona Doctor Josep Trueta | Girona , Spain, 17007Hospital Universitario La Princesa | Madrid , Spain, 28006Hospital Universitario Madrid Sanchinarro | Madrid , Spain, 28050Hospital Universitario de Salamanca | Salamanca , Spain, 37007Hospital Universitario Virgen Del Rocio | Seville , Spain, 41013Skånes Universitetssjukhus Lund | Lund Skåne LÄN [se-12], Sweden, 22185Falu Lasarett | Falun , Sweden, 791 82Sahlgrenska Universitetssjukhuset | Gothenburg , Sweden, 41345Universitetssjukhuset Örebro | Örebro Örebro LÄN [se-18], Sweden, 701 85China Medical University Hospital | Taichung , Taiwan, 40447National Cheng Kung University Hospital | Tainan , Taiwan, 704National Taiwan University Hospital | Taipei , Taiwan, 10002Ege Universitesi Hastanesi | Izmir İ̇zmir, Turkey (Türkiye), 35100Dokuz Eylul Universitesi Hastanesi | Izmir İ̇zmir, Turkey (Türkiye), 35340Akdeniz Universitesi Hastanesi | Antalya , Turkey (Türkiye), 07070University Hospital of Wales | Cardiff South Glamorgan, United Kingdom, CF14 4XW
Investigators
Study Director: Pfizer CT.gov Call Center, Pfizer