{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"GMMG HD7","nct_id":"NCT03617731","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gmmg-hd7-nct03617731. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients in arm IA are treated with 3 cycles RVd (lenalidomide 25 mg/d p.o. d1 - 14 and d22 - 35; bortezomib 1.3 mg/m2 s.c. d1, 4, 8, 11, 22, 25, 29, 32; dexamethasone p.o. 20 mg/d d1-2, 4-5, 8-9, 11-12, 15, 22-23, 25-26, 29-30, 32-33).Treatment repeats every 42 days (d43 = cycle 2 d1). Standard intensification: For all patients, stem cells are mobilized by GMMG Standard protocols (CAD: cyclophosphamide, doxorubicin, dexamethasone) and G-CSF. At least 7.5x106 CD34+ cells/kg body weight are harvested. High dose treatment (melphalan 200mg/m², HDT) followed by autologous stem cell transplantation (ASCT) is started 4 - 6 weeks after CAD. For patients not in CR after HDT1, a second HDT is performed within 3 months.","label":"IA","type":"ACTIVE_COMPARATOR"},{"description":"Patients in arm IB are treated with 3 cycles RVd + Isatuximab (lenalidomide 25 mg/d p.o. d1 - 14 and d22 - 35; bortezomib 1.3 mg/m2 s.c. d1, 4, 8, 11, 22, 25, 29, 32;dexamethasone p.o. 20 mg/d d1-2, 4-5, 8-9, 11-12, 15, 22-23, 25-26, 29-30, 32-33).Isatuximab (10 mg/kg i.v. C1: d 1, 8, 15, 22, 29; C2-3: d 1, 15, 29).Treatment repeats every 42 days (d43 = cycle 2 d1). Standard intensification: For all patients, stem cells are mobilized by GMMG Standard protocols (CAD: cyclophosphamide, doxorubicin, dexamethasone) and G-CSF. At least 7.5x106 CD34+ cells/kg body weight are harvested. High dose treatment (melphalan 200mg/m², HDT) followed by autologous stem cell transplantation (ASCT) is started 4 - 6 weeks after CAD. For patients not in CR after HDT1, a second HDT is performed within 3 months.","label":"IB","type":"EXPERIMENTAL"},{"description":"maintenance treatment with Lenalidomide 10mg/d (increased to 15mg/d after 3 months) repeated every 28d. Maintenance treatment is planned for up to 36 months or until progression if progression occurs first.","label":"IIA","type":"ACTIVE_COMPARATOR"},{"description":"maintenance treatment with Lenalidomide 10mg/d (increased to 15mg/d after 3 months) + Isatuximab (10 mg/kg; C1: d1, 8, 15, 22; C2-C3: d1 + 15; C4-39:d1, repeated every 28d). Within the trial, maintenance treatment is planned for up to 36 months or until progression if progression occurs first.","label":"IIB","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-06","type":"ESTIMATED"},"conditions":["Multiple Myeloma"],"enrollment":{"count":662,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Lenalidomide","otherNames":["Revlimid"],"type":"DRUG"},{"name":"Bortezomib","otherNames":["Velcade"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Isatuximab","otherNames":[],"type":"DRUG"}],"last_update":"2026-02-03","lead_sponsor":"University of Heidelberg Medical Center","official_title":"A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2028-06","type":"ESTIMATED"},"primary_outcomes":[{"measure":"MRD negativity after induction Treatment (comparison of arms IA and IB)","timeFrame":"18 weeks after start of study treatment"},{"measure":"Progression Free Survival (PFS) after second randomization (arms IIA and IIB)","timeFrame":"time from 2. randomization to progression or death from any cause whichever comes first, censored after three years of maintenance therapy"}],"references":[{"citation":"Jin JX, Ginde VR, Huhn S, Reichert P, Bertsch U, Fenk R, Besemer B, Boquoi A, Schroers R, von Metzler I, Hanel M, Mann C, Leypoldt LB, Heilmeier B, Scheid C, Peters-Regehr T, Blau IW, Muller-Tidow C, Luntz S, Holderried TAW, Trautmann-Grill K, Gezer D, Klaiber-Hakimi M, Muller M, Shumilov E, Knauf W, Michel CS, Geer T, Riesenberg H, Lutz C, Raab MS, Weinhold N, Hoffmann M, Benner A, Findeisen P, Weisel KC, Salwender HJ, Mai EK, Goldschmidt H; German-Speaking Myeloma Multicenter Group (GMMG) HD7 Investigators. Peripheral Measurable Residual Disease Activity Assessment by MALDI-TOF Mass Spectrometry in Patients With Newly Diagnosed Multiple Myeloma in the Phase III GMMG-HD7 Trial. J Clin Oncol. 2026 Aug;44(22):2079-2086. doi: 10.1200/JCO-25-02957. Epub 2026 May 21.","pmid":"42166704","type":"DERIVED"},{"citation":"Mai EK, Bertsch U, Pozek E, Fenk R, Besemer B, Hanoun C, Schroers R, von Metzler I, Hanel M, Mann C, Leypoldt LB, Heilmeier B, Huhn S, Vogel SK, Hundemer M, Scheid C, Blau IW, Luntz S, Weinhold N, Tichy D, Holderried TAW, Trautmann-Grill K, Gezer D, Klaiber-Hakimi M, Muller M, Shumilov E, Knauf W, Michel CS, Geer T, Riesenberg H, Lutz C, Raab MS, Benner A, Hoffmann M, Weisel KC, Salwender HJ, Goldschmidt H; German-Speaking Myeloma Multicenter Group (GMMG) HD7 Investigators; German-speaking Myeloma Multicenter Group (GMMG) HD7. Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial. J Clin Oncol. 2025 Apr 10;43(11):1279-1288. doi: 10.1200/JCO-24-02266. Epub 2024 Dec 9.","pmid":"39652594","type":"DERIVED"},{"citation":"Mai EK, Hielscher T, Bertsch U, Salwender HJ, Zweegman S, Raab MS, Munder M, Pantani L, Mancuso K, Brossart P, Beksac M, Blau IW, Durig J, Besemer B, Fenk R, Reimer P, van der Holt B, Hanel M, von Metzler I, Graeven U, Muller-Tidow C, Boccadoro M, Scheid C, Dimopoulos MA, Hillengass J, Weisel KC, Cavo M, Sonneveld P, Goldschmidt H. Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients. Leukemia. 2024 Mar;38(3):640-647. doi: 10.1038/s41375-023-02105-6. Epub 2023 Dec 7.","pmid":"38062124","type":"DERIVED"},{"citation":"Kauer J, Freundt EP, Schmitt A, Weinhold N, Mai EK, Muller-Tidow C, Goldschmidt H, Raab MS, Kriegsmann K, Sauer S. Stem cell collection after lenalidomide, bortezomib and dexamethasone plus elotuzumab or isatuximab in newly diagnosed multiple myeloma patients: a single centre experience from the GMMG-HD6 and -HD7 trials. BMC Cancer. 2023 Nov 21;23(1):1132. doi: 10.1186/s12885-023-11507-9.","pmid":"37990162","type":"DERIVED"},{"citation":"Goldschmidt H, Mai EK, Bertsch U, Fenk R, Nievergall E, Tichy D, Besemer B, Durig J, Schroers R, von Metzler I, Hanel M, Mann C, Asemissen AM, Heilmeier B, Weinhold N, Huhn S, Kriegsmann K, Luntz SP, Holderried TAW, Trautmann-Grill K, Gezer D, Klaiber-Hakimi M, Muller M, Khandanpour C, Knauf W, Scheid C, Munder M, Geer T, Riesenberg H, Thomalla J, Hoffmann M, Raab MS, Salwender HJ, Weisel KC; German-Speaking Myeloma Multicenter Group (GMMG) HD7 investigators. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Haematol. 2022 Nov;9(11):e810-e821. doi: 10.1016/S2352-3026(22)00263-0.","pmid":"36328040","type":"DERIVED"}],"start_date":{"date":"2018-10-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)","url":"https://clinicaltrials.gov/study/NCT03617731"},"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/gmmg-hd7-nct03617731"}