Recruiting NCT05020236
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elranatamab, Daratumumab, Pomalidomide, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Brazil, Canada +17
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
AN 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
Overview
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
Interventions
- Drug Elranatamab
subcutaneous - Drug Daratumumab
Daratumumab / hyaluronidase, subcutaneous - Drug Pomalidomide
oral - Drug Dexamethasone
oral
Primary outcome measures
- Part 1 Safety Lead-In: Incidence of dose limiting toxicities [Time frame: First 42 days after first elranatamab dose]
- Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria [Time frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months]
- Part 3: Frequency of treatment-emergent adverse events [Time frame: First 84 days after first elranatamab dose]
Secondary outcome measures (12)
- Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria [Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months]
- Overall survival [Time frame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months]
- Objective response rate per International Myeloma Working Group criteria [Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months]
- Duration of response per International Myeloma Working Group criteria [Time frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months]
- Time to response per International Myeloma Working Group criteria [Time frame: From date of randomization to date of confirmed objective response, assessed up to 51 months]
- Complete response rate per International Myeloma Working Group criteria [Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months]
- Duration of complete response per International Myeloma Working Group criteria [Time frame: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months]
- Minimal residual disease negativity rate per International Myeloma Working Group criteria [Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months]
- Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria [Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months]
- Progression free survival on next-line treatment per International Myeloma Working Group criteria [Time frame: From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months]
- Frequency of treatment-emergent adverse events [Time frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.]
- Frequency of abnormal laboratory results [Time frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Clovis Community Medical Center — Clovis
- Community Regional Medical Center — Fresno
- UCHealth Poudre Valley Hospital — Fort Collins
- UCHealth Greeley Hospital — Greeley
- Sylvester Comprehensive Cancer Center - Aventura — Aventura
- Sylvester Comprehensive Cancer Center - Coral Springs — Coral Springs
- University of Miami Hospital and Clinics - Deerfield Beach — Deerfield Beach
- Sylvester Comprehensive Cancer Center - Hollywood — Hollywood
- … and 3 more centers
China · 10 centers
- Fujian Medical University Union Hospital — Fuzhou
- Nanfang Hospital of Southern Medical University — Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School — Nanjing
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou
- Shandong Provincial Hospital — Jinan
- Institute of hematology&blood disease hospital — Tianjin
- … and 2 more centers
Spain · 10 centers
- Institut Català d'Oncologia - L'Hospitalet — L'Hospitalet Del Llobregat
- Hospital Universitari Mutua Terrassa — Terrassa
- Clinica Universidad de Navarra — Pamplona
- Hospital Universitario de Toledo — Toledo
- Hospital Universitari Vall d'Hebron — Barcelona
- Hospital Universitari De Girona Doctor Josep Trueta — Girona
- Hospital Universitario La Princesa — Madrid
- Hospital Universitario Madrid Sanchinarro — Madrid
- … and 2 more centers
Brazil · 9 centers
- Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador — Salvador
- Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa — Porto Alegre
- Hospital Mae de Deus — Porto Alegre
- Clínica Médica São Germano LTDA — SP
- Instituto de Educação, Pesquisa e Gestão em Saúde — Rio de Janeiro
- HU UNIFESP / SPDM - Hospital São Paulo — São Paulo
- Clínica Médica São Germano S/S Ltda — São Paulo
- Instituto D'Or de Pesquisa e Ensino (IDOR) — São Paulo
- … and 1 more center
Japan · 7 centers
- National Hospital Organization Shibukawa Medical Center — Shibukawa
- Tohoku University Hospital — Sendai
- Akita University Hospital — Akita
- National Hospital Organization Kumamoto Medical Center — Kumamoto
- Nagasaki University Hospital — Nagasaki
- National Hospital Organization Okayama Medical Center — Okayama
- Yamagata University Hospital — Yamagata
Australia · 5 centers
- Pindara Private Hospital — Benowa
- QScan Radiology Clinics — Clayfield
- Gallipoli Medical Research Foundation — Greenslopes
- Slade Pharmacy — Richmond
- Linear Clinical Research — Perth
New Zealand · 5 centers
- North Shore Hospital — Auckland
- Labtests Auckland Ltd. — Auckland
- Aotearoa Clinical Trials — Auckland
- Waikato District Health Board, Waikato Hospital — Hamilton
- Palmerston North Hospital — Roslyn
Sweden · 4 centers
- Skånes Universitetssjukhus Lund — Lund
- … and 3 more centers
Czechia · 3 centers
- Fakultní nemocnice Brno Bohunice — Brno
- Fakultni Nemocnice Plzen — Plzen - Lochotin
- Fakultni poliklinika — Prague
France · 3 centers
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren — Limoges
- Hôpital Saint Antoine — Paris
- Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique — Pierre-Bénite
Poland · 3 centers
- Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii — Bydgoszcz
- Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw
Taiwan · 3 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 3 centers
Center list to be confirmed — check the primary protocol.
Canada · 2 centers
- CIUSSS de l'Est-de-l'Île-de-Montréal — Montreal
- Saskatoon Cancer Center — Saskatoon
Germany · 2 centers
- Charité Universitätsmedizin Berlin — Berlin
- Universitätsklinikum rechts der Isar, Technische Universität München (TUM) — München
Greece · 2 centers
- Alexandra General Hospital of Athens — Athens
- Theageneio Cancer Hospital of Thessaloniki — Thessaloniki
Italy · 2 centers
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola — Bologna
Norway · 2 centers
- Oslo Universitetssykehus Ullevål — Oslo
- St Olavs Hospital — Trondheim
Argentina · 1 center
- Hospital Universitario Austral — Presidente Derqui
Finland · 1 center
- Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) — Helsinki
Mexico · 1 center
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey
United Kingdom · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05020236 · C1071005 · MAGNETISMM-5 · 2023-509208-14-00