Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-27 @ 7:54 PM
Study NCT ID:
NCT05650632
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2022-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-12-06', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm A (Part 1 and Part 2) and Arm C: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events', 'timeFrame': 'Up to Day 28', 'description': 'CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines'}, {'measure': 'Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])', 'timeFrame': 'Up to Day 28', 'description': 'AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.'}], 'secondaryOutcomes': [{'measure': 'Arm A and Arm C: Number of Cytokine Release Syndrome (CRS) Events', 'timeFrame': 'Up to 3 Years', 'description': 'CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Cancer', 'ABBV-383', 'B-Cell Maturation Antigen'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-108', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Multiple Myeloma (MM) is a cancer of the blood\'s plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.\n\nABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 3 Arms; Arm A (Parts 1 and 2), Arm B and Arm C. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. "In Arm C, the step-up dose identified in Arm A will be used followed by the target dose of ABBV-383 to investigate outpatient administration of ABBV-383. Around 180 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 40 sites across the world.\n\nParticipants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have measurable disease as outlined in the protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance of \\<= 2. Arm C only: ECOG performance of \\<= 1.\n* Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.\n* Must be naïve to treatment with ABBV-383.\n* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.\n* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \\[ADC\\] or chimeric antigen receptor T-cell \\[CAR-T\\] directed against BCMA).\n* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of ABBV-383.\n\nExclusion Criteria:\n\n* Arm A: Received BCMA-targeted therapy.\n* Arm C: Rapidly progressing disease per investigator."}, 'identificationModule': {'nctId': 'NCT05650632', 'briefTitle': 'A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects With Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'M24-108'}, 'secondaryIdInfos': [{'id': '2023-504674-38-00', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (Part 1): ABBV-383 Dose Escalation', 'description': 'B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.', 'interventionNames': ['Drug: ABBV-383']}, {'type': 'EXPERIMENTAL', 'label': 'Arm A (Part 2): ABBV-383 Dose Expansion', 'description': 'BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.', 'interventionNames': ['Drug: ABBV-383']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: ABBV-383 BCMA Exposed', 'description': 'Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.', 'interventionNames': ['Drug: ABBV-383']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: ABBV-383 Step Up', 'description': 'Participants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.', 'interventionNames': ['Drug: ABBV-383']}], 'interventions': [{'name': 'ABBV-383', 'type': 'DRUG', 'description': 'Intravenous Infusion', 'armGroupLabels': ['Arm A (Part 1): ABBV-383 Dose Escalation', 'Arm A (Part 2): ABBV-383 Dose Expansion', 'Arm B: ABBV-383 BCMA Exposed', 'Arm C: ABBV-383 Step Up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Arizona /ID# 251405', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Highlands Oncology Group - Springdale /ID# 267742', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers - Aurora /ID# 268574', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medical Oncology Hematology Consultants /ID# 268560', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hope And Healing Cancer Services /ID# 268536', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology And Hematology /ID# 268179', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Tulane University School of Medicine /ID# 251204', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester /ID# 251164', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NHO Revive Research Institute, LLC /ID# 267869', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '10029-6542', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mt Sinai /ID# 251166', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065-6007', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of North Carolina /ID# 251203', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Atrium Health Wake Forest Baptist Medical Center /ID# 251165', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University Of Cincinnati Medical Center /ID# 251746', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Willamette Valley Cancer Institute and Research Center /ID# 267088', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '37232-0021', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt Ingram Cancer Center /ID# 252470', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Texas Oncology - Central/South Texas /ID# 268563', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oncology Consultants /ID# 268323', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Texas Oncology - Northeast Texas /ID# 268877', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Virginia Cancer Specialists - Fairfax /ID# 268559', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98109-4405', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center. /ID# 267940', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwest Medical Specialties Tacoma /ID# 267117', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre /ID# 252053', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute /ID# 252151', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '5000', 'city': 'Odense', 'state': 'Region Syddanmark', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Odense University Hospital /ID# 251261', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '7100', 'city': 'Vejle', 'state': 'Region Syddanmark', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Vejle Sygehus /ID# 251260', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '13009', 'city': 'Marseille', 'state': 'Bouches-du-Rhone', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Institut Paoli-Calmettes /ID# 252100', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '94010', 'city': 'Créteil', 'state': 'Paris', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Pays de la Loire Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'state': 'Rhone', 'status': 'RECRUITING', 'country': 'France', 'facility': 'HCL - Hopital Lyon Sud /ID# 251223', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86000', 'city': 'Poitiers', 'state': 'Vienne', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Poitiers - La miletrie /ID# 251219', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '75012', 'city': 'Paris', 'status': 'COMPLETED', 'country': 'France', 'facility': 'AP-HP - Hopital Saint-Antoine /ID# 252326', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '91120', 'city': 'Jerusalem', 'state': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Hadassah Medical Center-Hebrew University /ID# 252079', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '5265601', 'city': 'Ramat Gan', 'state': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center /ID# 251329', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'state': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center /ID# 251573', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '4941492', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Rabin Medical Center /ID# 251330', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla /ID# 251528', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '37711', 'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca /ID# 251529', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'zip': 'NW1 2BU', 'city': 'London', 'state': 'Greater London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'University College London Hospital /ID# 251357', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '0161 446 3285'}], 'facility': 'The Christie Hospital /ID# 251774', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}