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

doi:10.1016/S2352-3026(22)00263-0

Clinical Trial

. 2022 Nov;9(11):e810-e821.

doi: 10.1016/S2352-3026(22)00263-0.

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

Hartmut Goldschmidt¹, Elias K Mai², Uta Bertsch³, Roland Fenk⁴, Eva Nievergall², Diana Tichy⁵, Britta Besemer⁶, Jan Dürig⁷, Roland Schroers⁸, Ivana von Metzler⁹, Mathias Hänel¹⁰, Christoph Mann¹¹, Anne M Asemissen¹², Bernhard Heilmeier¹³, Niels Weinhold², Stefanie Huhn², Katharina Kriegsmann², Steffen P Luntz¹⁴, Tobias A W Holderried¹⁵, Karolin Trautmann-Grill¹⁶, Deniz Gezer¹⁷, Maika Klaiber-Hakimi¹⁸, Martin Müller¹⁹, Cyrus Khandanpour²⁰, Wolfgang Knauf²¹, Christof Scheid²², Markus Munder²³, Thomas Geer²⁴, Hendrik Riesenberg²⁵, Jörg Thomalla²⁶, Martin Hoffmann²⁷, Marc S Raab², Hans J Salwender²⁸, Katja C Weisel¹²; German-Speaking Myeloma Multicenter Group (GMMG) HD7 investigators

Collaborators, Affiliations

Collaborators

German-Speaking Myeloma Multicenter Group (GMMG) HD7 investigators:
Anne M Asemissen, Joachim Behringer, Helga Bernhard, Christiane Bernhardt, Uta Bertsch, Britta Besemer, Igor W Blau, Claus Bolling, Daniel Debatin, Gerrit Dingeldein, Jan Dürig, Roland Fenk, Barbara Ferstl, Claudia Fest, Stefan Fronhoffs, Stephan Fuhrmann, Tobias Gaska, Thomas Geer, Deniz Gezer, Hartmut Goldschmidt, Martin Görner, Ullrich Graeven, Jochen Grassinger, Mathias Hänel, Bernhard Heilmeier, Michael Heinsch, Gerhard Held, Martin Hoffmann, Tobias A W Holderried, Olaf Hopfer, Stefanie Huhn, Peter Immenschuh, Dominic Kaddu-Mulindwa, Cyrus Khandanpour, Maika Klaiber-Hakimi, Martine Klausmann, Stefan Klein, Wolfgang Knauf, Yon-Dschun Ko, Georg Köchling, Michael Koenigsmann, Philippe Kostrewa, Doris Maria Kraemer, Stephan Kremers, Katharina Kriegsmann, Martin Kropff, Paul La Rosée, Steffen P Luntz, Rolf Mahlberg, Elias K Mai, Christoph Mann, Uwe Martens, Ivana von Metzler, Martin Müller, Markus Munder, Michael Neise, Eva Nievergall, Holger Nückel, Wolfram Pönisch, Maria Procaccianti, Marc S Raab, Mohammed R Rafiyan, Peter Reimer, Armin Riecke, Hendrik Riesenberg, Mathias Rummel, Volker Runde, Hans J Salwender, Markus Schaich, Christoph Scheid, Martin Schmidt-Hieber, Stefan Schmitt, Daniel Schöndube, Roland Schroers, Andreas Schwarzer, Peter Staib, Heike Steiniger, Dirk Sturmberg, Jörg Thomalla, Diana Tichy, Hans-Joachim Tischler, Karolin Trautmann-Grill, Arne Trummer, Barbara Tschechne, Walter Verbeek, Niels Weinhold, Katja C Weisel, Bettina Whitlock, Maike de Wit, Matthias Zaiß, Carsten Ziske

Affiliations

¹ Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany; National Center for Tumor Diseases Heidelberg, Heidelberg, Germany. Electronic address: hartmut.goldschmidt@med.uni-heidelberg.de.
² Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
³ Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany; National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.
⁴ Department of Hematology, Oncology, and Clinical Immunology, University Hospital Düsseldorf, Düsseldorf, Germany.
⁵ Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.
⁶ Department of Internal Medicine II, University Hospital Tübingen, Tübingen, Germany.
⁷ Department for Hematology and Stem Cell Transplantation, University Hospital Essen, Essen, Germany.
⁸ Medical Clinical, University Hospital Bochum, Bochum, Germany.
⁹ Department of Medicine, Hematology, and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
¹⁰ Department of Internal Medicine III, Clinic Chemnitz, Chemnitz, Germany.
¹¹ Department for Hematology, Oncology, and Immunology, University Hospital of Gießen and Marburg, Marburg, Germany.
¹² Department of Oncology, Hematology and Blood and Marrow Transplant, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
¹³ Clinic for Oncology and Hematology, Hospital Barmherzige Brueder Regensburg, Regensburg, Germany.
¹⁴ Coordination Centre for Clinical Trials Heidelberg, Heidelberg, Germany.
¹⁵ Department of Oncology, Hematology, ImmunoOncology, and Rheumatology, University Hospital Bonn, Bonn, Germany.
¹⁶ Department of Internal Medicine I, University Hospital Dresden, Dresden, Germany.
¹⁷ Department of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.
¹⁸ Clinic for Hematology, Oncology and Palliative Care, Marien Hospital Düsseldorf, Düsseldorf, Germany.
¹⁹ Clinic for Hematology, Oncology and Immunology, Klinikum Siloah Hannover, Hannover, Germany.
²⁰ Medical Clinic A, University Hospital Münster, Münster, Germany.
²¹ Center for Hematology and Oncology Bethanien, Frankfurt, Germany.
²² Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany.
²³ Department of Internal Medicine III, University Hospital Mainz, Mainz, Germany.
²⁴ Department of Internal Medicine III, Diakoneo Clinic Schwäbisch-Hall, Schwäbisch-Hall, Germany.
²⁵ Hematology and Oncology Center, Bielefeld, Germany.
²⁶ Hematology and Oncology Center, Koblenz, Germany.
²⁷ Medical Clinic A, Clinic Ludwigshafen, Ludwigshafen, Germany.
²⁸ Asklepios Tumorzentrum Hamburg, AK Altona, AK St Georg, Hamburg, Germany.

PMID: 36328040
DOI: 10.1016/S2352-3026(22)00263-0

Clinical Trial

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

Hartmut Goldschmidt et al. Lancet Haematol. 2022 Nov.

. 2022 Nov;9(11):e810-e821.

doi: 10.1016/S2352-3026(22)00263-0.

Authors

Collaborators

German-Speaking Myeloma Multicenter Group (GMMG) HD7 investigators:
Anne M Asemissen, Joachim Behringer, Helga Bernhard, Christiane Bernhardt, Uta Bertsch, Britta Besemer, Igor W Blau, Claus Bolling, Daniel Debatin, Gerrit Dingeldein, Jan Dürig, Roland Fenk, Barbara Ferstl, Claudia Fest, Stefan Fronhoffs, Stephan Fuhrmann, Tobias Gaska, Thomas Geer, Deniz Gezer, Hartmut Goldschmidt, Martin Görner, Ullrich Graeven, Jochen Grassinger, Mathias Hänel, Bernhard Heilmeier, Michael Heinsch, Gerhard Held, Martin Hoffmann, Tobias A W Holderried, Olaf Hopfer, Stefanie Huhn, Peter Immenschuh, Dominic Kaddu-Mulindwa, Cyrus Khandanpour, Maika Klaiber-Hakimi, Martine Klausmann, Stefan Klein, Wolfgang Knauf, Yon-Dschun Ko, Georg Köchling, Michael Koenigsmann, Philippe Kostrewa, Doris Maria Kraemer, Stephan Kremers, Katharina Kriegsmann, Martin Kropff, Paul La Rosée, Steffen P Luntz, Rolf Mahlberg, Elias K Mai, Christoph Mann, Uwe Martens, Ivana von Metzler, Martin Müller, Markus Munder, Michael Neise, Eva Nievergall, Holger Nückel, Wolfram Pönisch, Maria Procaccianti, Marc S Raab, Mohammed R Rafiyan, Peter Reimer, Armin Riecke, Hendrik Riesenberg, Mathias Rummel, Volker Runde, Hans J Salwender, Markus Schaich, Christoph Scheid, Martin Schmidt-Hieber, Stefan Schmitt, Daniel Schöndube, Roland Schroers, Andreas Schwarzer, Peter Staib, Heike Steiniger, Dirk Sturmberg, Jörg Thomalla, Diana Tichy, Hans-Joachim Tischler, Karolin Trautmann-Grill, Arne Trummer, Barbara Tschechne, Walter Verbeek, Niels Weinhold, Katja C Weisel, Bettina Whitlock, Maike de Wit, Matthias Zaiß, Carsten Ziske

Affiliations

¹ Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany; National Center for Tumor Diseases Heidelberg, Heidelberg, Germany. Electronic address: hartmut.goldschmidt@med.uni-heidelberg.de.
² Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
³ Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany; National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.
⁴ Department of Hematology, Oncology, and Clinical Immunology, University Hospital Düsseldorf, Düsseldorf, Germany.
⁵ Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.
⁶ Department of Internal Medicine II, University Hospital Tübingen, Tübingen, Germany.
⁷ Department for Hematology and Stem Cell Transplantation, University Hospital Essen, Essen, Germany.
⁸ Medical Clinical, University Hospital Bochum, Bochum, Germany.
⁹ Department of Medicine, Hematology, and Oncology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
¹⁰ Department of Internal Medicine III, Clinic Chemnitz, Chemnitz, Germany.
¹¹ Department for Hematology, Oncology, and Immunology, University Hospital of Gießen and Marburg, Marburg, Germany.
¹² Department of Oncology, Hematology and Blood and Marrow Transplant, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
¹³ Clinic for Oncology and Hematology, Hospital Barmherzige Brueder Regensburg, Regensburg, Germany.
¹⁴ Coordination Centre for Clinical Trials Heidelberg, Heidelberg, Germany.
¹⁵ Department of Oncology, Hematology, ImmunoOncology, and Rheumatology, University Hospital Bonn, Bonn, Germany.
¹⁶ Department of Internal Medicine I, University Hospital Dresden, Dresden, Germany.
¹⁷ Department of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.
¹⁸ Clinic for Hematology, Oncology and Palliative Care, Marien Hospital Düsseldorf, Düsseldorf, Germany.
¹⁹ Clinic for Hematology, Oncology and Immunology, Klinikum Siloah Hannover, Hannover, Germany.
²⁰ Medical Clinic A, University Hospital Münster, Münster, Germany.
²¹ Center for Hematology and Oncology Bethanien, Frankfurt, Germany.
²² Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany.
²³ Department of Internal Medicine III, University Hospital Mainz, Mainz, Germany.
²⁴ Department of Internal Medicine III, Diakoneo Clinic Schwäbisch-Hall, Schwäbisch-Hall, Germany.
²⁵ Hematology and Oncology Center, Bielefeld, Germany.
²⁶ Hematology and Oncology Center, Koblenz, Germany.
²⁷ Medical Clinic A, Clinic Ludwigshafen, Ludwigshafen, Germany.
²⁸ Asklepios Tumorzentrum Hamburg, AK Altona, AK St Georg, Hamburg, Germany.

PMID: 36328040
DOI: 10.1016/S2352-3026(22)00263-0

Abstract

Background: Anti-CD38 monoclonal antibodies have consistently shown increased efficacy when added to standard of care for patients with multiple myeloma. We aimed to assess the efficacy of isatuximab in addition to lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed transplantation-eligible multiple myeloma.

Methods: This open-label, multicentre, randomised, active-controlled, phase 3 trial was done at 67 academic and oncology practice centres in Germany. This study is ongoing and divided into two parts; herein, we report results from part 1. Eligible patients were aged 18-70 years; had a confirmed diagnosis of untreated multiple myeloma requiring systemic treatment and a WHO performance status of 0-2; and were eligible for induction therapy, high-dose melphalan and autologous haematopoietic stem-cell transplantation, and maintenance treatment. Patients were randomly assigned (1:1) to receive three 42-day cycles of induction therapy either with isatuximab plus lenalidomide, bortezomib, and dexamethasone (isatuximab group) or lenalidomide, bortezomib, and dexamethasone alone (control group) using a web-based system and permuted blocks. Patients in both groups received lenalidomide (25 mg orally on days 1-14 and 22-35), bortezomib (1·3 mg/m² subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32), and dexamethasone (20 mg orally on days 1-2, 4-5, 8-9, 11-12, 15, 22-23, 25-26, 29-30, and 32-33). Isatuximab was given as 10 mg/kg intravenously on days 1, 8, 15, 22, and 29 of cycle 1 and on days 1, 15, and 29 of cycles 2 and 3. The primary endpoint was minimal residual disease (MRD) negativity assessed by flow cytometry, in the intention-to-treat (ITT) population. This study is registered with ClinicalTrials.gov, NCT03617731.

Findings: Between Oct 23, 2018, and Sep 22, 2020, 660 patients were included in the ITT analysis (331 in the isatuximab group and 329 in the control group). 654 (99%) patients were White, two were African, one was Arabic, and three were Asian. 250 (38%) were women and 410 (62%) were men. The median age was 59 years (IQR 54-64). MRD negativity after induction therapy was reached in 166 (50%) patients in the isatuximab group versus 117 (36%) in the control group (OR 1·82 [95% CI 1·33-2·48]; p=0·00017). Median follow-up time from start to end of induction therapy was 125 days (IQR 125-131) versus 125 days (125-132). At least one grade 3 or 4 adverse event occurred in 208 (63%) of 330 patients versus 199 (61%) of 328 patients. Neutropenia of grade 3 or 4 occurred in 77 (23%) versus 23 (7%) patients and infections of grade 3 or 4 occurred in 40 (12%) versus 32 (10%) patients. Among 12 deaths during induction therapy, one death due to septic shock in the isatuximab group and four deaths (one cardiac decompensation, one hepatic and renal failure, one cardiac arrest, and one drug-induced enteritis) in the control group were considered treatment-related.

Interpretation: Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone for induction therapy improved rates of MRD negativity with no new safety signals in patients with newly diagnosed transplantation-eligible multiple myeloma.

Funding: Sanofi and Bristol Myers Squibb (Celgene).

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Conflict of interest statement

Declaration of interests HG reports financial and trial medication support for this GMMG-HD7 trial from Bristol Myers Squibb and Sanofi; consulting from Adaptive Biotechnology, Amgen, Bristol Myers Squibb, and Janssen; honoraria from Amgen, Bristol Myers Squibb, Celgene, Chugai, GlaxoSmithKline, Janssen, and Novartis; research funding from Amgen, Bristol Myers Squibb, Celgene, Chugai, Incyte, Janssen, Molecular Partner, MSD, Mundipharma, and Novartis; grants from Amgen, Celgene, Chugai, Janssen, and Johns Hopkins University. EKM reports consulting or advisory role, honoraria, research funding, travel accommodation, and expenses from Bristol Myers Squibb (Celgene), GlaxoSmithKline, Janssen-Cilag, Sanofi, Stemline, and Takeda. RF reports consulting or advisory role, honoraria, travel accommodation, and expenses from Amgen, Bristol Myers Squibb (Celgene), GlaxoSmithKline, Janssen, and Takeda. BB reports honoraria from Amgen, GlaxoSmithKline, Janssen, Sanofi, and Takeda; and travel accommodation, and expanses from Janssen. JD reports honoraria from Celgene, Janssen, and Roche; advisory role, travel accommodation, and expenses from Amgen, AstraZeneca, Abbvie, Bristol Myers Squibb, Celgene, Janssen, and Takeda; and speakers bureau from Celgene and Janssen. RS reports consulting for Bristol Myers Squibb, Gilead (Kite), Janssen, and Novartis; and honoraria from Bristol Myers Squibb, Gilead (Kite), Janssen, Roche, and Sanofi. IvM reports consulting for Amgen, AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Pfizer, Sanofi, and Takeda; honoraria from Sanofi; and travel accommodation and expenses from Takeda. MHa reports consulting for Amgen, Bayer Vital, Celgene, Gilead, GlaxoSmithKline, Jazz Pharmaceuticals, Novartis, Pfizer, Roche, and Takeda; and honoraria from Novartis. CM reports consulting for Celgene. AMA reports honoraria from Bristol Myers Squibb (Celgene), GlaxoSmithKline, and Pfizer. BH reports consulting for Sanofi-Aventis. NW reports an advisory role for Glaxo Smith Kline; and research Funding from Bristol Myers Squibb. KK reports honoraria from Sanofi. TAWH reports a consulting or advisory role for Celgene, Gilead Sciences, GlaxoSmithKline, Jazz Pharmaceuticals, Novartis, and Sanofi; speakers bureau for Amgen and MSD; and travel accommodation and expenses from AbbVie, Daiichi Sankyo, Eurocept Pharmaceuticals, Janssen, Medac, and Therakos. KT-G reports consulting, an advisory role, honoraria, travel accommodation, and expenses from GlaxoSmithKline, Novartis, and Takeda. DG reports consulting and honoraria from Amgen, Bristol Myers Squibb, Celgene, and Takeda. MK-H reports honoraria from Amgen, Bristol Myers Squibb, Janssen-Cilag, Roche, and Takeda; and an advisory role for Amgen, Bristol Myers Squibb, Janssen, and Sanofi. CK reports honoraria from AstraZeneca, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Sanofi, and Takeda; and research funding from AstraZeneca and Sanofi. WK reports consulting for AstraZeneca, BeiGene, and Janssen; honoraria from AbbVie, Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, Celgene, Janssen, and Sanofi. CS reports honoraria from AbbVie, Amgen, Bristol Myers Squibb, Glaxo Smith Kline, Janssen, Pfizer, Oncopeptides, Sanofi, and Takeda; travel accommodation and expanses from Bristol Myers Squibb, Janssen, Novartis, and Takeda; and research funding from Janssen, Novartis, and Takeda. MMun reports consulting for AbbVie, Bristol Myers Squibb, Glaxo Smith Kline, Janssen, Sanofi, and Takeda; honoraria from Amgen, Bristol Myers Squibb, Janssen, and Takeda; research funding from Incyte; and travel accommodation and expenses from Amgen. MHo reports consulting for Sanofi-Aventis. MSR reports consulting or an advisory role for AbbVie, Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Novartis, Roche, and Sanofi; honoraria from AbbVie and GlaxoSmithKline; and research funding from Novartis and Sanofi. HJS reports honoraria and an advisory role from AbbVie, Amgen, Bristol Myers Squibb (Celgene), Chugai, GlaxoSmithKline, Janssen-Cilag, Oncopeptides, Pfizer, Roche, Sanofi, Sebia, TAD Pharma, and Takeda; travel accommodation and expenses from Amgen, Bristol Myers Squibb (Celgene), GlaxoSmithKline, Janssen-Cilag, and Sanofi. KCW reports consulting for AbbVie, Adaptive Biotech, Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Karyopharm, Novartis, Oncopeptides, Pfizer, Roche, Sanofi, Stemline, and Takeda; honoraria from AbbVie, Adaptive Biotech, Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Karyopharm, Novartis, Oncopeptides, Pfizer, Roche, Sanofi, Stemline, and Takeda; research funding from Amgen, Bristol Myers Squibb, Celgene, Glaxo Smith Kline, Janssen, and Sanofi; travel accommodation and expenses from AbbVie, Adaptive Biotech, Amgen, Bristol Myers Squibb, Celgene, Janssen, Glaxo Smith Kline, Karyopharm, Oncopeptides, Roche, Sanofi, Stemline, and Takeda. All other authors declare no competing interests.

Comment in

Maximising response depth is important in multiple myeloma.
Chen X, Davies FE. Chen X, et al. Lancet Haematol. 2022 Nov;9(11):e798-e799. doi: 10.1016/S2352-3026(22)00321-0. Lancet Haematol. 2022. PMID: 36328036 No abstract available.

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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

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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

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