protocolSection identificationModule nctId: NCT06292780, orgStudyIdInfo id: R5458-ONC-2274, secondaryIdInfos id: 2023-507809-34-00, type: OTHER, domain: EUCT Number, briefTitle: A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis), acronym: LINKER-AL2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2028-08-26, completionDateStruct date: 2035-02-26, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching an experimental drug called linvoseltamab ("study drug").This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.The study consists of 2 phases (Phase 1 and Phase 2):* In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.* In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.The study is looking at several other research questions, including:* How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long* How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long* What the right dosing regimen is for linvoseltamab* What side effects may happen from taking linvoseltamab* How much linvoseltamab is in your blood at different times* Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects), conditionsModule conditions: Relapsed/Refractory Systemic Light Chain Amyloidosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Note: Participants enrolled in Phase 2 will be randomized 1:1, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Linvoseltamab, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicity (DLTs), primaryOutcomes measure: Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC), secondaryOutcomes measure: Achievement of hematologic CR, as determined by the IRC, secondaryOutcomes measure: Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC, secondaryOutcomes measure: Achievement of overall hematologic response (PR or better), as determined by the IRC, secondaryOutcomes measure: Time to initial hematologic response, secondaryOutcomes measure: Time to best hematologic response, secondaryOutcomes measure: Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC, secondaryOutcomes measure: Hematologic progression-free survival (PFS), secondaryOutcomes measure: Incidence of death, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Severity of TEAEs, secondaryOutcomes measure: Incidence of serious adverse events (SAEs), secondaryOutcomes measure: Severity of SAEs, secondaryOutcomes measure: Incidence of adverse events of special interest (AESIs), secondaryOutcomes measure: Severity of AESIs, secondaryOutcomes measure: Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2, secondaryOutcomes measure: Incidence of TEAEs in dose regimen 1 vs 2, secondaryOutcomes measure: Severity of TEAEs in dose regimen 1 vs 2, secondaryOutcomes measure: Incidence of SAEs in dose regimen 1 vs 2, secondaryOutcomes measure: Severity of SAEs in dose regimen 1 vs 2, secondaryOutcomes measure: Incidence of AESIs in dose regimen 1 vs 2, secondaryOutcomes measure: Severity of AESIs in dose regimen 1 vs 2, secondaryOutcomes measure: Time from treatment initiation to hematologic disease progression as determined by the IRC, secondaryOutcomes measure: Time from treatment initiation to cardiac deterioration, as determined by the IRC, secondaryOutcomes measure: Time from treatment initiation to kidney deterioration as determined by the IRC, secondaryOutcomes measure: Time from treatment initiation to death as determined by the IRC, secondaryOutcomes measure: Time from initiation of treatment to date of death from any cause, secondaryOutcomes measure: Achievement of renal response in participants with renal involvement at baseline, as determined by IRC, secondaryOutcomes measure: Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC, secondaryOutcomes measure: Time to first renal response in participants with renal involvement at baseline, secondaryOutcomes measure: Time to first cardiac response in participants with cardiac involvement at baseline, secondaryOutcomes measure: Linvoseltamab concentration in serum over time, secondaryOutcomes measure: Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time, secondaryOutcomes measure: Titers of ADAs to linvoseltamab over time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False