Nctid:
NCT06223516
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009101", "term"=>"Multiple Myeloma"}, {"id"=>"D000054219", "term"=>"Neoplasms, Plasma Cell"}], "ancestors"=>[{"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000020141", "term"=>"Hemostatic Disorders"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000010265", "term"=>"Paraproteinemias"}, {"id"=>"D000001796", "term"=>"Blood Protein Disorders"}, {"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000006474", "term"=>"Hemorrhagic Disorders"}, {"id"=>"D000008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D000007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M12058", "name"=>"Multiple Myeloma", "asFound"=>"Multiple Myeloma", "relevance"=>"HIGH"}, {"id"=>"M27588", "name"=>"Neoplasms, Plasma Cell", "asFound"=>"Multiple Myeloma", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M21977", "name"=>"Hemostatic Disorders", "relevance"=>"LOW"}, {"id"=>"M5059", "name"=>"Blood Coagulation Disorders", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M13178", "name"=>"Paraproteinemias", "relevance"=>"LOW"}, {"id"=>"M5077", "name"=>"Blood Protein Disorders", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M9560", "name"=>"Hemorrhagic Disorders", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"T3947", "name"=>"Multiple Myeloma", "asFound"=>"Multiple Myeloma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>55}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-06-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2027-02-21", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-01", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-02-21", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events", "timeFrame"=>"Up to 2 cycles (56 days)", "description"=>"Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity."}, {"measure"=>"Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events", "timeFrame"=>"Up to 2 cycles (56 days)", "description"=>"ICANS events will be graded using ASTCT, with a higher grade indicating higher severity."}, {"measure"=>"Maximum Observed Concentration (Cmax) of ABBV-383", "timeFrame"=>"Up to 32 weeks", "description"=>"Cmax of ABBV-383."}, {"measure"=>"Time to Cmax (Tmax) of ABBV-383", "timeFrame"=>"Up to 32 weeks", "description"=>"Tmax of ABBV-383."}, {"measure"=>"Trough Concentration (Ctrough) of ABBV-383", "timeFrame"=>"Up to 32 weeks", "description"=>"Ctrough of ABBV-383."}, {"measure"=>"Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383", "timeFrame"=>"Up to 24 weeks", "description"=>"AUC of ABBV-383."}], "secondaryOutcomes"=>[{"measure"=>"Overall Response Rate (ORR)", "timeFrame"=>"Up to 24 months", "description"=>"The ORR is defined as the percentage of participants who achieve a best overall response of confirmed PR or better determined by international myeloma working group (IMWG) criteria, prior to the initiation of subsequent myeloma therapy."}, {"measure"=>"Percentage of Participants Achieving Stringent Complete Response (sCR),", "timeFrame"=>"Up to 24 months", "description"=>"sCR is defined as participants achieving negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, \\< 5% plasma cells in bone marrow, normal free light chain (FLC) ratio, and Absence of clonal cells in bone marrow by immunohistochemistry."}, {"measure"=>"Percentage of Participants Achieving Complete Response (CR)", "timeFrame"=>"Up to 24 months", "description"=>"CR is defined as participants achieving negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, \\< 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio."}, {"measure"=>"Percentage of Participants Achieving Very Good Partial Response (VGPR)", "timeFrame"=>"Up to 24 months", "description"=>"VGPR is defined as participants achieving serum and urine M-protein detectable by immunofixation but not on electrophoresis, \\>= 90% reduction in serum M-protein plus urine, and for participants in whom the only measurable disease is by serum FLC levels, \\>= 90% decrease in the difference between involved and uninvolved FLC levels."}, {"measure"=>"Percentage of Participants Achieving Partial Response (PR)", "timeFrame"=>"Up to 24 months", "description"=>"PR is defined as participants achieving \\>= 50% reduction of serum M-protein, reduction in 24-hour urinary M-protein by \\>= 90% as noted in the protocol, \\>= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline."}, {"measure"=>"Duration of Response (DoR)", "timeFrame"=>"Up to 24 months", "description"=>"DoR will be defined as the time from the date of first response \\[partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR)\\] to the earliest occurrence of progressive disease, or death, whatever occurs first."}, {"measure"=>"Progression Free Survival (PFS)", "timeFrame"=>"Up to 24 months", "description"=>"PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) per international myeloma working group (IMWG) criteria, or death, whichever occurs first."}, {"measure"=>"Time to Response (TTR)", "timeFrame"=>"Up to 24 months", "description"=>"TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria."}, {"measure"=>"Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)", "timeFrame"=>"Up to 27 months", "description"=>"Incidence and concentration of ADAs."}, {"measure"=>"Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)", "timeFrame"=>"Up to 27 months", "description"=>"Incidence and concentration of NAbs."}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Multiple Myeloma", "ABBV-383"], "conditions"=>["Multiple Myeloma"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://www.abbvieclinicaltrials.com/study/?id=M23-001", "label"=>"Related Info"}]}, "descriptionModule"=>{"briefSummary"=>"Multiple myeloma (MM) is a cancer of the blood's plasma cells. 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 the safety and pharmacokinetics 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 MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 25 sites across the world\n\nIn Arm A participants will receive one of two doses of ABBV-383 as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration.\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* Eastern Cooperative Oncology Group (ECOG) performance of \\<= 2.\n* Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug.\n* Must be naïve to treatment with ABBV-383.\n\nExclusion Criteria:\n\n- Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody."}, "identificationModule"=>{"nctId"=>"NCT06223516", "briefTitle"=>"Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"AbbVie"}, "officialTitle"=>"A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma", "orgStudyIdInfo"=>{"id"=>"M23-001"}, "secondaryIdInfos"=>[{"id"=>"2023-507901-32-00", "type"=>"OTHER", "domain"=>"EU CT"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"ABBV-383 Dose A", "description"=>"Participants will receive Dose A of ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.", "interventionNames"=>["Drug: Subcutaneous (SC) ABBV-383", "Drug: Intravenous (IV) ABBV-383"]}, {"type"=>"EXPERIMENTAL", "label"=>"ABBV-383 Dose B", "description"=>"Participants will receive Dose B of ABBV-383 as an SC injection and IV infusions, during the 151 week study duration.", "interventionNames"=>["Drug: Subcutaneous (SC) ABBV-383", "Drug: Intravenous (IV) ABBV-383"]}, {"type"=>"EXPERIMENTAL", "label"=>"ABBV-383 Expansion", "description"=>"Participants will receive the selected dose from Arm A of ABBV-383 as SC injections, during the 151 week study duration.", "interventionNames"=>["Drug: Subcutaneous (SC) ABBV-383"]}], "interventions"=>[{"name"=>"Subcutaneous (SC) ABBV-383", "type"=>"DRUG", "description"=>"SC Injection", "armGroupLabels"=>["ABBV-383 Dose A", "ABBV-383 Dose B", "ABBV-383 Expansion"]}, {"name"=>"Intravenous (IV) ABBV-383", "type"=>"DRUG", "description"=>"IV Infusion", "armGroupLabels"=>["ABBV-383 Dose A", "ABBV-383 Dose B"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"27157", "city"=>"Winston-Salem", "state"=>"North Carolina", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Atrium Health Wake Forest Baptist Medical Center /ID# 260807", "geoPoint"=>{"lat"=>36.09986, "lon"=>-80.24422}}, {"zip"=>"20246", "city"=>"Hamburg", "status"=>"RECRUITING", "country"=>"Germany", "facility"=>"Universitaetsklinikum Hamburg-Eppendorf /ID# 260444", "geoPoint"=>{"lat"=>53.57532, "lon"=>10.01534}}, {"zip"=>"5265601", "city"=>"Ramat Gan", "state"=>"Tel-Aviv", "status"=>"RECRUITING", "country"=>"Israel", "facility"=>"The Chaim Sheba Medical Center /ID# 261699", "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# 261525", "geoPoint"=>{"lat"=>32.08088, "lon"=>34.78057}}, {"zip"=>"91120", "city"=>"Jerusalem", "state"=>"Yerushalayim", "status"=>"RECRUITING", "country"=>"Israel", "facility"=>"Hadassah Medical Center-Hebrew University /ID# 261446", "geoPoint"=>{"lat"=>31.76904, "lon"=>35.21633}}, {"zip"=>"466-8650", "city"=>"Nagoya", "state"=>"Aichi", "status"=>"RECRUITING", "country"=>"Japan", "facility"=>"Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286", "geoPoint"=>{"lat"=>35.18147, "lon"=>136.90641}}, {"zip"=>"589-8511", "city"=>"Osakasayama-shi", "state"=>"Osaka", "status"=>"RECRUITING", "country"=>"Japan", "facility"=>"Kindai University Hospital /ID# 266016", "geoPoint"=>{"lat"=>34.69374, "lon"=>135.50218}}], "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"}}}}
