protocolSection identificationModule nctId: NCT06282978, orgStudyIdInfo id: GEM-RANTAB, secondaryIdInfos id: 2023-504273-21, type: EUDRACT_NUMBER, briefTitle: Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: PETHEMA Foundation, class: OTHER, descriptionModule briefSummary: The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.Safety refers to the measurement of:i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests).ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infectionsThe study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study., conditionsModule conditions: Multiple Myeloma in Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an open label, multicenter, phase II study of Elranatamab as single agent. The primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy as evaluated with the rate of complete Response and Undetectable Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: None (Open Label), enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Elranatamab (PF-06863135), outcomesModule primaryOutcomes measure: To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate annually by NGF until loss of response, the rate of Undetectable Measurable Residual Disease (% of patients with MRD negative by NGF method and with a sensitivity level of 10-5) of elranatamab in patients with R/R multiple myeloma., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in physical examination and ECOG performance status scale (0-5)., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in 12-lead ECG., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in Echocardiogram / MUGA., secondaryOutcomes measure: To determine Circulating Tumor Cells (CTC) at baseline to evaluate its prognostic value., secondaryOutcomes measure: To determine serum BCMA levels and its correlation with response., secondaryOutcomes measure: To do gene expression techniques (RNA sequencing and single cell sequencing studies) coupled with intelligent clinical and molecular data analysis (i.e. machine learning) to identify factors that could predict response to elranatamab., secondaryOutcomes measure: To determine MRD value with alternative methods, secondaryOutcomes measure: To characterize patients' immune system, secondaryOutcomes measure: To define genomic determinants of response/resistance, secondaryOutcomes measure: To evaluate Overall Response Rate of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate Duration of Response of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate Time to first and best response of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate Progression-free survival (PFS) of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate Overall survival (OS) of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate PFS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate OS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate the Incidence of neurologic effects related to elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate the Incidence of cytopenias and infections related to elranatamab in patients with relapsed/refractory multiple myeloma., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínico Universitario de Santiago ~ CHUS, status: NOT_YET_RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: Marta Sonia Gonzalez Perez, MD, role: CONTACT, contacts name: Marta Sonia Gonzalez Perez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol, status: NOT_YET_RECRUITING, city: Badalona, state: Barcelona, zip: 08916, country: Spain, contacts name: Albert Oriol Rocafiguera, MD, role: CONTACT, contacts name: Albert Oriol Rocafiguera, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals, status: NOT_YET_RECRUITING, city: L'Hospitalet De Llobregat, state: Barcelona, zip: 08908, country: Spain, contacts name: Ana Sureda, MD, role: CONTACT, contacts name: Ana Sureda, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, locations facility: Hospital Universitario Marqués de Valdecilla, status: NOT_YET_RECRUITING, city: Santander, state: Cantabria, zip: 39008, country: Spain, contacts name: Enrique M Ocio San Miguel, MD, role: CONTACT, contacts name: Enrique M Ocio San Miguel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46472, lon: -3.80444, locations facility: Hospital Universitario de Jerez de la Frontera, status: NOT_YET_RECRUITING, city: Jerez De La Frontera, state: Cádiz, zip: 11407, country: Spain, contacts name: Sebastian Garzon Lopez, MD, role: CONTACT, contacts name: Sebastian Garzon Lopez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.68645, lon: -6.13606, locations facility: Hospital Son Llàtzer, status: NOT_YET_RECRUITING, city: Palma De Mallorca, state: Illes Balears, zip: 07198, country: Spain, contacts name: Joan LL Bargay, MD, role: CONTACT, contacts name: Joan LL Bargay, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.56939, lon: 2.65024, locations facility: CHU de Gran Canaria Doctor Negrín, status: NOT_YET_RECRUITING, city: Las Palmas De Gran Canaria, state: Las Palmas, zip: 35010, country: Spain, contacts name: Alexia T Suarez Cabrera, MD, role: CONTACT, contacts name: Alexia T Suarez Cabrera, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.09973, lon: -15.41343, locations facility: Hospital HM Sanchinarro, status: NOT_YET_RECRUITING, city: Sanchinarro, state: Madrid, zip: 28050, country: Spain, contacts name: Jaime Perez de Oteysa, MD, role: CONTACT, contacts name: Jaime Perez de Oteysa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Clínico Universitario Virgen de la Arrixaca, status: NOT_YET_RECRUITING, city: El Palmar, state: Murcia, zip: 30120, country: Spain, contacts name: Begoña Navarro de Almenzar, MD, role: CONTACT, contacts name: Begoña Navarro de Almenzar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.93939, lon: -1.16095, locations facility: Clinica Universidad Navarra (CUN), status: NOT_YET_RECRUITING, city: Pamplona, state: Navarra, zip: 31008, country: Spain, contacts name: Jesus San Miguel Izquierdo, MD, role: CONTACT, phone: +34 948 296 296, email: sanmiguel@unav.es, contacts name: Paula Rodriguez Otero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.81687, lon: -1.64323, locations facility: H. Clínic i Provincial de Barcelona, status: NOT_YET_RECRUITING, city: Barcelona, zip: 08036, country: Spain, contacts name: Joan Bladé, MD, role: CONTACT, phone: +34 932275428, email: jblade@clinic.cat, contacts name: Laura Rossiñol, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital de Cabueñes, status: RECRUITING, city: Gijón, zip: 33394, country: Spain, contacts name: María Esther González García, MD, role: CONTACT, phone: + 34 985 18 50 00, contacts name: María Esther González García, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.53573, lon: -5.66152, locations facility: Instituto de Investigación Sanitaria Hospital 12 de Octubre, status: NOT_YET_RECRUITING, city: Madrid, zip: 28041, country: Spain, contacts name: Juan Jose Lahuerta, MD, role: CONTACT, phone: +34 91 779 28 39, email: jjlahuerta@telefonica.net, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Clínico Universitario Salamanca, status: RECRUITING, city: Salamanca, zip: 37007, country: Spain, contacts name: Mª Victoria Mateos, MD, role: CONTACT, phone: +34 923 291 100, phoneExt: 55384, email: mvmateos@usal.es, contacts name: Verónica González de la Calle, MD, role: CONTACT, phone: +34 923 291 100, phoneExt: 55629, email: vgcalle@saludcastillayleon.es, contacts name: Mª Victoria Mateos, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.96882, lon: -5.66388, locations facility: C.H. de Toledo (Virgen de la Salud), status: NOT_YET_RECRUITING, city: Toledo, zip: 45005, country: Spain, contacts name: Luis Felipe Casado Montero, MD, role: CONTACT, contacts name: Luis Felipe Casado Montero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.8581, lon: -4.02263, hasResults: False