Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-08 @ 12:05 AM
Study NCT ID:
NCT04649060
Status:
TERMINATED
Last Update Posted:
2023-06-08
First Post:
2020-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Slovakia', 'United States'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585069', 'term': 'melflufen'}, {'id': 'C482580', 'term': 'L-melphalanyl-p-L-fluorophenylalanine ethyl ester'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C556306', 'term': 'daratumumab'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trials@oncopeptides.com', 'phone': '+46 8 615 20 40', 'title': 'VP Chief Operating Officer', 'organization': 'Oncopeptides AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was put on clinical hold and later discontinued prematurely. Due to this, there is limited data available, and data cleaning was not done according to the original plan. Due to the early termination, the response assessments were done by investigators, not by an independent review committee.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from the start of study treatment until 30 days after the last dose of study drug or initiation of subsequent therapy whichever occurred first. Serious AEs (SAEs) were collected from signing of the informed consent form (ICF) until 30 days after the last dose of study treatment or initiation of subsequent therapy whichever occurred first. The maximum duration of treatment was 48 weeks, and the maximum duration of AEs/SAEs collection was 48 weeks + 30 days.', 'description': 'AE definition: An AE is any untoward medical occurrence in a patient or clinical study patient, temporally associated with the use of study treatment, whether or not considered related to the study treatment.\n\nAEs are grouped by MedDRA system organ class (SOC) and preferred term (PT).', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'deathsNumAffected': 2, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 22, 'seriousNumAtRisk': 26, 'deathsNumAffected': 3, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Crossover (From Arm B to the Same Treatment as Arm A)', 'description': 'Patients in Arm B were allowed to crossover and receive the same treatment as Arm A after a confirmed disease progression (2 patients crossed over).', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asymptomatic COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median PFS was not reached in Arm A. There were insufficient numbers of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.86', 'comment': 'The upper confidence limit was not available due to insufficient numbers of participants with events.', 'groupId': 'OG001', 'lowerLimit': '3.38', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '=0.0032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.184', 'ciLowerLimit': '0.052', 'ciUpperLimit': '0.650', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from the date of randomization to the date of first documentation of confirmed progressive disease (PD) or death due to any cause, whichever occurred first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000', 'lowerLimit': '38.8', 'upperLimit': '77.6'}, {'value': '29.6', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '50.2'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Proportion of patients who achieve a best-confirmed response of stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median DOR was not reached in Arm A and the 95% CI was not available due to insufficient numbers of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median DOR was not reached in Arm B and the upper confidence limit was not available due to insufficient numbers of participants with events.', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.525', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.418', 'ciLowerLimit': '0.026', 'ciUpperLimit': '6.693', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from the first evidence of confirmed assessment of sCR, CR, VGPR or PR to first confirmed disease progression, or death due to any cause. DOR is defined only for patients with a confirmed PR or better.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'title': 'Complete Response (CR)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very Good Partial Response (VGPR)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Partial Response (PR)', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Minimal Response (MR)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Stable Disease (SD)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Progressive Disease (PD)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Not Evaluable (NE)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Proportion of patients with sCR, CR, VGPR, PR, Minimal Response (MR), Stable Disease (SD), PD, or non-evaluable (NE).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': '70.4', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '86.2'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '68.1'}]}]}], 'analyses': [{'pValue': '0.0997', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'The proportion of patients who achieve a best confirmed response of sCR, CR, VGPR, PR, or MR.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Duration of Clinical Benefit (DOCB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median DOCB was not reached in Arm A and the 95% CI was not available due to insufficient numbers of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median DOCB was not reached in Arm B and the upper confidence limit was not available due to insufficient numbers of participants with events.', 'groupId': 'OG001', 'lowerLimit': '3.38', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.111', 'ciLowerLimit': '0.013', 'ciUpperLimit': '0.960', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from first evidence of confirmed assessment of sCR, CR, VGPR, PR, or MR to first confirmed disease progression, or to death due to any cause. DOCB is defined only for patients with a confirmed MR or better.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from randomization to the date of the first documented confirmed response in a patient who has responded with ≥PR.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median TTP was not reached in Arm A and the 95% CI was not available due to insufficient numbers of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median TTP was not reached in Arm B and the upper confidence limit was not available due to insufficient numbers of participants with events.', 'groupId': 'OG001', 'lowerLimit': '4.70', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0187', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.231', 'ciLowerLimit': '0.063', 'ciUpperLimit': '0.846', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from randomization to the date of the first documented confirmed PD', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Time to Next Treatment (TTNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': '11.04', 'comment': 'The 95% CI was not available due to insufficient numbers of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median TTNT was not reached in Arm B and the upper confidence limit was not available due to insufficient numbers of participants with events.', 'groupId': 'OG001', 'lowerLimit': '4.40', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.224', 'ciLowerLimit': '0.047', 'ciUpperLimit': '1.056', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from randomization to the date of next anti-myeloma treatment or until death.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'OG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'classes': [{'categories': [{'measurements': [{'value': '11.04', 'comment': 'The 95% CI is not available due to insufficient numbers of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median OS was not reached in Arm B and the 95% CI was not available due to insufficient numbers of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3721', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.086', 'ciUpperLimit': '2.569', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from randomization to death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed using the Full Analysis Set (FAS).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'FG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}], 'periods': [{'title': 'Arm A/Arm B Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Treated', 'comment': 'There were 6 randomized patients (5 in Arm A and 1 in Arm B) who never received treatment due to failure to meet treatment initiation criteria and/or consent withdrawal.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Patient Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Failed Criteria for Treatment Initiation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Crossover (Arm B)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'There were 2 patients in Arm B who crossed over and received Melflufen+Dexamethasone+Daratumumab after a confirmed disease progression and received at least one dose of treatment.', 'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (Melflufen+Dexamethasone+Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'BG001', 'title': 'Arm B (Daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '80'}, {'value': '66.7', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '83'}, {'value': '65.6', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<65', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '65 - ≤75', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': '>75', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.46', 'groupId': 'BG000', 'lowerLimit': '61.0', 'upperLimit': '103.8'}, {'value': '78.75', 'groupId': 'BG001', 'lowerLimit': '56.3', 'upperLimit': '107.6'}, {'value': '79.1', 'groupId': 'BG002', 'lowerLimit': '56.3', 'upperLimit': '107.6'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.4', 'groupId': 'BG000', 'lowerLimit': '151', 'upperLimit': '195'}, {'value': '167.0', 'groupId': 'BG001', 'lowerLimit': '150', 'upperLimit': '188'}, {'value': '168.7', 'groupId': 'BG002', 'lowerLimit': '150', 'upperLimit': '195'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) score', 'classes': [{'categories': [{'title': 'score = 0', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'score = 1', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'score = 2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '0=Normal activity, fully active, able to carry on all pre-disease performance without restriction. 1=Symptoms, but fully ambulatory, restricted in physically strenuous but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-25', 'size': 5082254, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-06T13:19', 'hasProtocol': True}, {'date': '2022-05-11', 'size': 984405, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-06T13:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Independent Review Committee was planned to be blinded to treatment assignment. Due to the early termination, the response assessments were only done by investigators, not by an independent review committee.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'The sponsor decided to terminate the study due to financial issues following an FDA request for a partial clinical hold.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2020-11-24', 'resultsFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-12', 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from the date of randomization to the date of first documentation of confirmed progressive disease (PD) or death due to any cause, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Proportion of patients who achieve a best-confirmed response of stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR).'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from the first evidence of confirmed assessment of sCR, CR, VGPR or PR to first confirmed disease progression, or death due to any cause. DOR is defined only for patients with a confirmed PR or better.'}, {'measure': 'Best Response', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Proportion of patients with sCR, CR, VGPR, PR, Minimal Response (MR), Stable Disease (SD), PD, or non-evaluable (NE).'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'The proportion of patients who achieve a best confirmed response of sCR, CR, VGPR, PR, or MR.'}, {'measure': 'Duration of Clinical Benefit (DOCB)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from first evidence of confirmed assessment of sCR, CR, VGPR, PR, or MR to first confirmed disease progression, or to death due to any cause. DOCB is defined only for patients with a confirmed MR or better.'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from randomization to the date of the first documented confirmed response in a patient who has responded with ≥PR.'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from randomization to the date of the first documented confirmed PD'}, {'measure': 'Time to Next Treatment (TTNT)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from randomization to the date of next anti-myeloma treatment or until death.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization until the end of study (approximately 12 months).', 'description': 'Time from randomization to death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed Multiple Myeloma', 'Relapsed-Refractory Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '37646660', 'type': 'DERIVED', 'citation': 'Pour L, Szarejko M, Bila J, Schjesvold FH, Spicka I, Maisnar V, Jurczyszyn A, Grudeva-Popova Z, Hajek R, Usenko G, Thuresson M, Norin S, Jarefors S, Bakker NA, Richardson PG, Mateos MV. Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study. Haematologica. 2024 Mar 1;109(3):895-905. doi: 10.3324/haematol.2023.283509.'}, {'pmid': '37646657', 'type': 'DERIVED', 'citation': 'Ocio EM, Efebera YA, Hajek R, Straub J, Maisnar V, Eveillard JR, Karlin L, Mateos MV, Oriol A, Ribrag V, Richardson PG, Norin S, Obermuller J, Bakker NA, Pour L. ANCHOR: melflufen plus dexamethasone and daratumumab or bortezomib in relapsed/refractory multiple myeloma: final results of a phase I/IIa study. Haematologica. 2024 Mar 1;109(3):867-876. doi: 10.3324/haematol.2023.283490.'}]}, 'descriptionModule': {'briefSummary': 'This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with Relapsed-Refractory Multiple Myeloma (RRMM) who were either double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or had received at least 3 prior lines of therapy including an IMiD and a PI.\n\nPatients received treatment with melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity, or patient/treating physician decision. Patients in the daratumumab treatment arm had the option to receive treatment with melflufen+dexamethasone+daratumumab after confirmed progressive disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A prior diagnosis of multiple myeloma with documented disease progression after the last line of therapy\n* Double refractory to an IMiD and a PI (regardless of the number of prior lines of therapy) or have received at least 3 prior lines of therapy including an IMiD and a PI\n* Prior treatment with daratumumab or another anti-CD38 antibody may be allowed under certain circumstances:\n\n * Achieved at least partial response (PR) and not refractory to an anti-CD38 antibody\n * At least 6 months since the last dose of anti-CD38 antibody\n * Not discontinued anti-CD38 antibody treatment due to related Grade ≥ 3 toxicity\n* Male and female of childbearing potential agree to use contraception during the treatment period and at least 3 months after the last dose\n\nExclusion Criteria:\n\n* Primary refractory disease (i.e., never responded with at least Minimal Response to any prior therapy for multiple myeloma)\n* Prior treatment with CD38 CAR-T cell therapy or CD38/CD3 bispecific antibodies\n* Any medical condition that may interfere with safety or participation in this study\n* Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast, or very low and low-risk prostate cancer in active surveillance\n* Known or suspected amyloidosis, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n* Known central nervous system (CNS) or meningeal involvement of myeloma\n* Prior stem cell transplant (autologous and/or allogenic) within 6 months of initiation of therapy or prior allogeneic stem cell transplantation with active graft-versus-host-disease\n* Prior treatment with melflufen'}, 'identificationModule': {'nctId': 'NCT04649060', 'acronym': 'LIGHTHOUSE', 'briefTitle': 'Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oncopeptides AB'}, 'officialTitle': 'A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'OP-108'}, 'secondaryIdInfos': [{'id': '2019-002161-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (melflufen+dexamethasone+daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7', 'interventionNames': ['Drug: Melflufen', 'Drug: Dexamethasone', 'Drug: Daratumumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B (daratumumab)', 'description': 'Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7', 'interventionNames': ['Drug: Daratumumab']}], 'interventions': [{'name': 'Melflufen', 'type': 'DRUG', 'otherNames': ['Melphalan Flufenamide', 'Pepaxto', 'Pepaxti'], 'description': 'Powder for solution for i.v. infusion', 'armGroupLabels': ['Arm A (melflufen+dexamethasone+daratumumab)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Dex'], 'description': 'Oral tablets', 'armGroupLabels': ['Arm A (melflufen+dexamethasone+daratumumab)']}, {'name': 'Daratumumab', 'type': 'DRUG', 'otherNames': ['Darzalex FASPRO'], 'description': 'Solution for s.c. injection', 'armGroupLabels': ['Arm A (melflufen+dexamethasone+daratumumab)', 'Arm B (daratumumab)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinical Hematology Clinic', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Specialized Hospital for Active Treatment of Hematological Diseases, Clinical Hematology Clinic', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Kralovice', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove, 4th Internal Clinic of Hematology', 'geoPoint': {'lat': 49.98192, 'lon': 13.48747}}, {'city': 'Ostrava-Poruba', 'country': 'Czechia', 'facility': 'University Hospital Ostrava, Clinic of Hematooncology'}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'General University Hospital in Prague, 1st Internal Clinic - Clinic of Hematology', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'JSC K. Eristavi National Center of Experimental and Clinical Surgery', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Malkhaz Katsiashvili Multiprofile EMC LTD', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Siegen', 'country': 'Germany', 'facility': 'St. Marien-Hospital Siegen gem. GmbH, Clinic for Hematology, Medical Oncology and Palliative Medicine', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Alexandra General Hospital, Therapeutic Clinic', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Ulleval University Hospital, Oslo Myeloma Center', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Chorzów', 'country': 'Poland', 'facility': 'Independent Public Healthcare Facility Municipal Hospitals, Teaching Department of Hematology And Prevention of Neoplastic Diseases', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'University Clinical Center, Teaching Department of Hematology and Transplantology', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Independent Public Healthcare Facility University Hospital in Krakow, Teaching Unit of the Hematology Department', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'St. John of Dukla Oncology Center of Lublin Region, Department of Hematology and Bone Marrow Transplantation', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Leningrad Regional Clinical Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'V.D. Seredavin Samara Regional Clinical Hospital', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic of Barcelona, Department of Hematology', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cherkasy', 'country': 'Ukraine', 'facility': 'Cherkasy Regional Oncology Dispensary, Regional Treatment and Diagnostic Hematology Center', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'city': 'Chernihiv', 'country': 'Ukraine', 'facility': 'Chernihiv Medical Center of Modern Oncology, Hematology Department', 'geoPoint': {'lat': 51.50541, 'lon': 31.28656}}, {'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'City Clinical Hospital No. 4 City Hematology Center', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Kyiv City Clinical Hospital No. 9, Hematology Department No. 1', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'National Institute of Cancer, Research Department of Hemoblastosis Chemotherapy and Adjuvant Treatment Methods, Department of Oncohematology with Adjuvant Treatment Methods Group', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Maria-Victorìa Mateos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complejo Hospitalario de Salamanca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oncopeptides AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}