{"preliminary_commentary":{"by_channel":{"x_thread":72},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT06022939\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"SWOG S2213","nct_id":"NCT06022939","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=swog-s2213-nct06022939. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes on days 1 and 15 as well as bortezomib SC over 3-5 minutes, cyclophosphamide PO or IV, and dexamethasone PO or IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening and at progression. Patients undergo bone marrow aspiration and biopsy within14-28 days post consolidation treatment and at progression. Patients undergo blood and urine sample collection at screening, at the start of each cycle, and the end of treatment and during follow up or at progression.","label":"Consolidation Arm I (Chemotherapy)","type":"ACTIVE_COMPARATOR"},{"description":"Patients undergo collection of peripheral blood stem cells. Patients receive melphalan IV for 1 cycle and then 2 days later receive the stem cell transplant IV in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening and at progression. Patients undergo bone marrow aspiration and biopsy within 60-90 days post initiation of stem cell transplant. Patients undergo blood and urine sample collection at screening, during treatment, and the end of treatment and during follow up or at progression.","label":"Consolidation Arm II (Chemotherapy, ASCT)","type":"EXPERIMENTAL"},{"description":"Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes on days 1, 8, 15 and 22 for 2 cycles and then days 1 and 15 for cycle 3. Patients receive bortezomib SC over 3-5 minutes, cyclophosphamide PO or IV, and dexamethasone PO or IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI or PET-CT and fat pad aspiration at screening. Patients undergo echocardiography at screening, the completion of induction, and at progression. Patients undergo bone marrow aspiration and biopsy at screening, post induction treatment and at progression. Patients undergo blood and urine sample collection at screening, at the start of each cycle, and the end of treatment and during follow up or at progression.","label":"Induction (Chemotherapy)","type":"EXPERIMENTAL"},{"description":"Patients receive maintenance daratumumab and hyaluronidase-fihj SC over 3-5 minutes on day 1 of each cycle. Cycles repeat every 28 days for up 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening, 12 months post consolidation treatment and at progression. Patients undergo bone marrow aspiration and biopsy 12 months post consolidation treatment and at progression. Patients undergo blood and urine sample collection at screening, during treatment, 12 months post consolidation treatment and during follow up or at progression.","label":"Maintenance (daratumumab and hyaluronidase-fihj)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2030-10-29","type":"ESTIMATED"},"conditions":["AL Amyloidosis"],"enrollment":{"count":338,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Autologous Hematopoietic Stem Cell Transplantation","otherNames":["AHSCT","Autologous","Autologous Hematopoietic Cell Transplantation","Autologous Stem Cell Transplant","Autologous Stem Cell Transplantation","Stem Cell Transplantation, Autologous"],"type":"PROCEDURE"},{"name":"Biopsy","otherNames":["BIOPSY_TYPE","Bx"],"type":"PROCEDURE"},{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Specimen Collection"],"type":"PROCEDURE"},{"name":"Bone Marrow Aspiration","otherNames":[],"type":"PROCEDURE"},{"name":"Bone Marrow Biopsy","otherNames":["Biopsy of Bone Marrow","Biopsy, Bone Marrow"],"type":"PROCEDURE"},{"name":"Bortezomib","otherNames":["[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid","LDP 341","MLN341","PS-341","PS341","Velcade"],"type":"DRUG"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","CT","CT Scan","tomography"],"type":"PROCEDURE"},{"name":"Cyclophosphamide","otherNames":["(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamide Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR- 138719"],"type":"DRUG"},{"name":"Daratumumab and Hyaluronidase-fihj","otherNames":["DARA Co-formulated with rHuPH20","DARA/rHuPH20","Daratumumab + rHuPH20","Daratumumab with rHuPH20","Daratumumab-rHuPH20","Daratumumab/Hyaluronidase-fihj","Daratumumab/rHuPH20 Co-formulation","Darzalex Faspro","Darzalex/rHuPH20","HuMax-CD38-rHuPH20","Recombinant Human Hyaluronidase Mixed with Daratumumab"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":["Aacidexam","Adexone","Aknichthol Dexa","Alba-Dex","Alin","Alin Depot","Alin Oftalmico","Amplidermis","Anemul mono","Auricularum","Auxiloson","Baycadron","Baycuten","Baycuten N","Cortidexason","Cortisumman","Decacort","Decadrol","Decadron","Decadron DP","Decalix","Decameth","Decasone R.p.","Dectancyl","Dekacort","Deltafluorene","Deronil","Desamethasone","Desameton","Dexa-Mamallet","Dexa-Rhinosan","Dexa-Scheroson","Dexa-sine","Dexacortal","Dexacortin","Dexafarma","Dexafluorene","Dexalocal","Dexamecortin","Dexameth","Dexamethasone Intensol","Dexamethasonum","Dexamonozon","Dexapos","Dexinoral","Dexone","Dinormon","Dxevo","Fluorodelta","Fortecortin","Gammacorten","Hemady","Hexadecadrol","Hexadrol","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","TaperDex","Visumetazone","ZoDex"],"type":"DRUG"},{"name":"Echocardiography","otherNames":["EC"],"type":"PROCEDURE"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging"],"type":"PROCEDURE"},{"name":"Melphalan","otherNames":["Alanine Nitrogen Mustard","CB-3025","L-PAM","L-Phenylalanine Mustard","L-Sarcolysin","L-Sarcolysin Phenylalanine mustard","L-Sarcolysine","Melphalanum","Phenylalanine Mustard","Phenylalanine Nitrogen Mustard","Sarcoclorin","Sarkolysin","WR-19813"],"type":"DRUG"},{"name":"Positron Emission Tomography","otherNames":["Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT"],"type":"PROCEDURE"},{"name":"Stem Cell Isolation","otherNames":["Isolation, Stem Cell","Stem Cell Collection","Stem Cell Recovery"],"type":"PROCEDURE"},{"name":"Survey Administration","otherNames":[],"type":"OTHER"}],"last_update":"2026-05-06","lead_sponsor":"SWOG Cancer Research Network","official_title":"A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients With Newly Diagnosed AL Amyloidosis","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2030-07-29","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Major organ deterioration progression-free survival (PFS)","timeFrame":"From date of randomization (Step 2 registration) to date of first documentation of hematologic progression, cardiac organ progression, renal organ progression, or death due to any cause, assessed up to 4 years"}],"references":[],"start_date":{"date":"2024-07-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis","url":"https://clinicaltrials.gov/study/NCT06022939"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/swog-s2213-nct06022939"}