AzTrials
AzTrials

Multiple MyelomaPhase 3NCT03617731

Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)

A Phase 3 study testing Lenalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 72 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Trial in patients with newly diagnosed myeloma to evaluate the effect of isatuximab in induction therapy with lenalidomide/bortezomib/dexamethasone (RVd) and in lenalidomide maintenance treatment Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Lenalidomide, Bortezomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
662 participants
Where
72 sitesGermany
Study dates
18 Oct 2018to Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (diagnostic criteria (IMWG updated criteria (2014)1) see appendix IA. For some patients systemic therapy may be required though these diagnostic criteria are not fulfilled. In this case the GMMG study office has to be consulted prior to inclusion.)
  • Patient is eligible for high dose therapy and autologous stem cell transplantation.
  • Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:2
  • Serum M-protein ≥ 10g/l (for IgA ≥ 5g/l)
  • Urine light-chain (M-protein) of ≥ 200 mg/24 hours
  • Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal
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  • Age 18 - 70 years inclusive
  • WHO performance status 0-2
  • Negative pregnancy test at inclusion (females of childbearing potential)
  • All patients must agree on the requirements regarding the lenalidomide pregnancy prevention plan described in section 6. For all men and females of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy.
  • All patients must
  • agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy
  • agree not to share study drug lenalidomide with another person and to return all unused study drug to the investigator or pharmacist
  • Ability of patient to understand character and individual consequences of the clinical trial
  • Provide written informed consent (must be available before enrolment in the trial)

Who cannot join

  • Patient has known hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids or H2 blockers that would prohibit further treatment with these agents.
  • Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
  • Plasma cell leukemia
  • Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy.) Previous therapy due to smouldering myeloma may be acceptable. In this case the GMMG study office has to be consulted prior to inclusion
  • Severe cardiac dysfunction (NYHA classification III-IV), ejection fraction < 40%
  • Significant hepatic dysfunction (ASAT and/or ALAT ≥ 3 times normal level and/or serum bilirubin ≥ 1.5 times normal level if not due to hereditary abnormalities as Gilbert's disease), unless related to myeloma.
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  • Patients with active or history of hepatitis B or C
  • HIV positivity
  • Patients with active, uncontrolled infections
  • Patients with severe renal insufficiency (Creatinine Clearance < 30ml/min)
  • Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0)
  • Patients with a history of active malignancy during the past 5 years with the exception of following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy
  • Patients with acute diffuse infiltrative pulmonary and/or pericardial disease
  • Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
  • Platelet count < 75 x 109/l
  • Haemoglobin < 8.0 g/dl, unless related to myeloma
  • Absolute neutrophil count (ANC) < 1.0 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed)
  • Corrected serum calcium > 14 mg/dl (> 3.5 mmol/l)
  • Unable or unwilling to undergo thromboprophylaxis
  • Pregnancy and lactation
  • Participation in other clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months.
  • Prisoners or subjects who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
  • No patients will be allowed to enrol in this trial more than once.
  • -

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

Germany72 sites

  • Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

    Aachen, 52074

  • Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin

    Bad Saarow, 15526

  • Charité, Campus Benjamin Franklin , III. Medizinische Abteilung (Hämatologie/Onkologie)

    Berlin, 12200

  • Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

    Berlin, 12351

  • HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie

    Berlin, 13125

  • Studiengesellschaft Onkologie Bielefeld GbR

    Bielefeld, 33604

  • Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin

    Bielefeld, D-33604

  • Medizinische Universitätsklinik, Knappschaftskrankenhaus

    Bochum, D-44892

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie

    Bonn, 53105

  • Johanniter Krankenhaus Bonn

    Bonn, 53113

  • Zentrum für ambulante Hämatologie und Onkologie (ZAHO)

    Bonn, 53113

  • Städtisches Klinikum Braunschweig, Med. Klinik III, Hämatologie und Onkologie

    Braunschweig, 38114

  • Klinikum Chemnitz GmbH, Innere Medizin III

    Chemnitz, D-09116

  • Uniklinik Köln, Klinik I für Innere Medizin

    Cologne, 50937

  • Carl-Thiem-Klinikum Cottbus gGmbH, II. Medizinische Klinik

    Cottbus, 03048

  • Onkologisches Studienzentrum Darmstadt

    Darmstadt, 64283

  • Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie

    Darmstadt, D-64283

  • Universitätsklinikum Carl Gustav Carus Dresden, an der Technischen Universität Dresden, Medizinische Klinik und Poliklinik I

    Dresden, 01307

  • HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität Düsseldorf

    Duisburg, 47166

  • Marien Hospital Düsseldorf GmbH, Klinik für Onkologie, Hämatologie und Palliativmedizin

    Düsseldorf, 40479

  • Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie

    Düsseldorf, D-40225

  • Universitätsklinik Erlangen

    Erlangen, 91054

  • St. Antonius-Hospital Eschweiler, Klinik für Hämatologie / Onkologie

    Eschweiler, 52249

  • Universitätsklinikum Essen, Klinik für Hämatologie

    Essen, D-45147

  • Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation

    Essen, D-45239

  • Gemeinschaftspraxis Prof. Dr. Michael Kiehl und Dipl. Med. Wolfgang Stein

    Frankfurt (Oder), 15236

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main, 60389

  • Agaplesion Markus Krankenhaus, Med. Klinik I

    Frankfurt am Main, 60431

  • Krankenhaus Nordwest, Institut für Klinisch-Onkologische Forschung

    Frankfurt am Main, 60488

  • Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II

    Frankfurt am Main, 60590

  • Klinikum Fulda, Klinisches Studienzentrum GmbH

    Fulda, 36043

  • Universitätsklinik der Justus-Liebig-Universität, Medizinische Klinik IV

    Giessen, 35385

  • Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch, Klinik für Hämatologie - Onkologie

    Goch, 47574

  • Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie

    Hagen, D-58095

  • Asklepios Klinik Hamburg St. Georg

    Hamburg, 20099

  • Universitätsklinikum Hamburg Eppendorf, Zentrum für Onkologie, Studienzentrale der II. Medizinischen Klinik

    Hamburg, 20246

  • Asklepios Klinik Hamburg Altona, II. Med. Klinik

    Hamburg, D-22763

  • Immunologisch-onkologisches MVZ am Siloah Krankenhaus

    Hanover, 30449

  • KRH Klinikum Siloah, Klinik für Hämatologie und Onkologie

    Hanover, 30459

  • Onkologische Schwerpunktpraxis Heidelberg

    Heidelberg, 69115

  • Krankenhaus St. Vincentius der evangelischen Stadtmission Heidelberg, Abt. Hämatologie, Onkologie, Rheumatologie

    Heidelberg, 69117

  • University Hospital Heidelberg, Med. Klinik V

    Heidelberg, D-69120

  • SLK Kliniken Heilbronn, Med. Klinik III

    Heilbronn, D-74078

  • Marien Hospital Herne

    Herne, 44625

  • Universitätsklinikum des Saarlandes, Innere Medizin I

    Homburg (Saar), 66421

  • Westpfalz-Klinikum GmbH, Klinik für Innere Medizin I

    Kaiserslautern, 67655

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

  • Praxisklinik für Hämatologie und Onkologie

    Koblenz, D-56068

  • Gemeinschaftspraxis für Hämatologie und Onkologie am Caritas Krankenhaus

    Lebach, 66822

  • Universitätsklinikum Leipzig AöR, Medizinische Klinik und Poliklinik I-Hämatologie und Zelltherapie, Internistische Onkologie, Hämostaseologie

    Leipzig, 04103

  • Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen am Rhein, 67063

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik

    Mainz, D-55131

  • III. Medizinische Klinik Hämatologie und Internistische Onkologie

    Mannheim, 68167

  • Mannheimer Onkologie Praxis

    Mannheim, D-68161

  • Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie

    Marburg, 35032

  • Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin

    Minden, 32429

  • Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I

    Mönchengladbach, D-41063

  • Universitätsklinikum Münster, Med. Klinik A

    Münster, 48149

  • Klinikum Osnabrück GmbH

    Osnabrück, 49076

  • Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie

    Paderborn, 33098

  • Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie

    Regensburg, 93049

  • Gemeinschaftspraxis für Hämatologie und Onkologie, Onkologisches Zentrum

    Saarlouis, 66740

  • Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III

    Schwäbisch Hall, 74523

  • ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg

    Siegburg, D-53721

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, D-67346

  • Klinikum Stuttgart, Stuttgart Cancer Center, Tumorzentrum Eva Mayr-Stihl

    Stuttgart, 70174

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier, 54290

  • University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II

    Tübingen, D-72076

  • Bundeswehrkrankenhaus Ulm, Abteilung Innere Medizin - Hämatologie und internistische Onkologie

    Ulm, 89081

  • Schwarzwald-Baar Klinikum, Innere Medizin II

    Villingen-Schwenningen, 78052

  • Rems-Murr-Kliniken gGmbH

    Winnenden, 71364

Other trials in Germany

About this study

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

Trial in patients with newly diagnosed myeloma to evaluate the effect of isatuximab in induction therapy with lenalidomide/bortezomib/dexamethasone (RVd) and in lenalidomide maintenance treatment

Read the detailed description

Prospective, multicentre, randomised, parallel group, open, phase III clinical trial, for patients with confirmed diagnosis of untreated multiple myeloma requiring systemic therapy.

Investigational Medicinal Products: Isatuximab, Lenalidomide

  1. Randomization: Patients are randomized in one of 2 study arms (IA or IB) before induction therapy. Patients randomized in arm IA will receive 3 cycles RVd (Bortezomib (Velcade®), Lenalidomide (Revlimid®, each cycle is 42 days), Dexamethasone). Patients in arm IB will additionally receive the monoclonal antibody Isatuximab in the 3 cycles RVd. After induction therapy patients undergo intensifying therapy according to GMMG standard (usually mobilization therapy followed by stem cell collection and autologous stem cell transplantation).
  2. Randomization: Before maintenance treatment patients are randomized in one of 2 study arms (IIA and IIB): Patients in arm IIA receive Lenalidomide maintenance therapy for three years, patients in arm IIB receive additional Isatuximab.

There are two primary objectives:

  1. to compare the induction regimen (IA vs IB) regarding minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity at least 1e-5)
  2. to compare the maintenance strategies (arms IIA vs IIB) regarding progression-free survival (PFS), defined as time from 2nd randomization (prior to maintenance therapy) to progression or death from any cause whichever occurs first.

The duration of the trial for each patients is expected to be 45-48 months (induction and intensification treatment: 6-9 months, 3 months rest between intensification and start of maintenance phase 36 months).

Being tested
Lenalidomide, Bortezomib, Dexamethasone, Isatuximab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid

    25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB)

  • BortezomibDrug

    Also called Velcade

    all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles

  • DexamethasoneDrug

    20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 and 22,23 and 25,26 and 29,30 and 32,33 in induction cycles 1-3 (Arms IA and IB). Maintenance cycle 1 on day 1, 8, 15, 22 Dexamethasone 20 mg/d per os (Arm IIA). In Arm IIB Dexamethasone 20 mg i.v. on days of Isatuximab infusion in the first maintenance cycle (d 1, 8, 15, 22), dexamethasone will be administered intravenously as part of the premedication. If an isatuximab dose is skipped or discontinued dexamethasone should be administered orally.

  • IsatuximabDrug

    10 mg/kg in the vein( i.v) on day 1,8,15, 22, 29 in induction cycle 1 on day 1, 15 and 29 in induction cycle 2 and 3 (Arm IB). 10 mg/kg i.v. on day 1,8, 15 and 22 in maintenance cycle 1, 10 mg/kg i.v. on day 1 and 15 in maintenance cycle 2 and 3, 10 mg/kg i.v. on day 1 in maintenance cycle 4 - 39 (Arm IIB)

Study groups in NCT03617731
Study groupRoleWhat they receive
IAActive comparatorPatients 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.
Receives: Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone
IBExperimentalPatients 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.
Receives: Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Isatuximab
IIAActive comparatormaintenance 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.
Receives: Drug: Lenalidomide
IIBExperimentalmaintenance 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.
Receives: Drug: Lenalidomide; Drug: Isatuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRD negativity after induction Treatment (comparison of arms IA and IB)

    Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)

    Measured: 18 weeks after start of study treatment

  2. Progression Free Survival (PFS) after second randomization (arms IIA and IIB)

    Response Evaluation by IMWG criteria

    Measured: time from 2. randomization to progression or death from any cause whichever comes first, censored after three years of maintenance therapy

Secondary outcomes (14)

  1. to compare the four treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding Progression free survival (PFS)

    Response evaluation by IMWG criteria

    Measured: time from 1. randomization (study inclusion) to progression or death whichever comes first (assessed up to 79 months)

  2. to compare all 4 treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding overall survival (OS) from time of 1.randomization

    survival status

    Measured: time from randomisation to time of death from any cause (assessed up to 79 months)

  3. Overall survival from second randomization

    survival status

    Measured: time from 2. randomization to time of death from any cause (assessed up to 75 months)

  4. Complete Response (CR) rates after induction therapy

    Response Evaluation by IMWG criteria

    Measured: After induction treatment (18 weeks after start of treatment)

  5. Complete Response (CR) after high dose therapy

    Response Evaluation by IMWG criteria

    Measured: After high dose therapy (9 or 12 months after start of therapy)

  6. Complete Response (CR) during/after maintenance therapy

    Response Evaluation by IMWG criteria

    Measured: During/after maintenance therapy (6 months after start of therapy up to 36 months of maintenance therapy)

  7. MRD negativity after high dose therapy

    Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)

    Measured: After high dose therapy (9 or 12 months after start of therapy)

  8. MRD negativity during and after maintenance therapy

    Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)

    Measured: up to 36 months after start of maintenance therapy

  9. Best response to treatment during the trial

    Response evaluation by IMWG criteria

    Measured: response assessment after 3 months, 4,5 months, 5,5 months, 9 months (if applicable: 3 months later after 2. high dose therapy) subsequently every 3 months during maintenance treatment, up to 48 months after start of study treatment

  10. PFS 2 (PFS after next line of therapy) from 2. randomization

    Response evaluation by IMWG criteria

    Measured: time from 2. randomization to time of overall end of trial (up to 75 months)

  11. Toxicity during induction and maintenance with respect to adverse events of CTC grade >3 (and specific adverse events of CTC grade > 2 as defined in the protocol and serious adverse events

    toxicity according CTCAE Version v5.0

    Measured: : from first administration of study drug until 30 days after last administration of study drug or any drug of the study treatment or upon start of a new subsequent chemotherapy, whichever occurs first

  12. Quality of Life Assessment

    EORTC (European Organization of Research and Treatment of Cancer) -QLQC30 Questionnaire to assess the quality of life of cancer patients. Impairment of daily life is asked in 4 scales from "not at all" (best) to "very much" (worst scale), EORTC-QLQMY20 questionnaire to assess health-related quality of life in patients with multiple myeloma with 4 scales from "not at all (best scale) to "very much" (worst scale); EQ(EuroQol Group)-5D-5L Health questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additionally a visual analogue scale from 100 (best) to 0 (worst scale) is used to assess the quality of health questionnaires.

    Measured: assessed at baseline, after ca. 4.5 months, 9 months, (additionally after 12 months,if a second high dose therapy is administered) after 12 months of maintenance and at end of study (up to 50 months)

  13. Pharmakokinetic analyses of Isatuximab in induction treatment of patients in Arm IB (selected sites only)

    Determination of serum concentration of isatuximab at different timepoints before, during and after isatuximab infusion

    Measured: Up to 18 weeks in induction treatment (C1: D1, before infusion, at end of infusion, 1 h after infusion, C1 D8,15,22,29 before infusion; C2 and 3:D1 before infusion

  14. Pharmakokinetic analyses of Isatuximab in maintenance treatment of patients in Arm IIB (selected sites only)

    Determination of serum concentration of isatuximab at different timepoints

    Measured: Up to 9 months (C1: D1, before infusion, at end of infusion, 1 h after infusion, C1 D8,15,22 before infusion, C2 -9, D1: before infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start18 Oct 2018
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 x 2 arms, 1. randomization before induction therapy (arm IA and IB), 2. randomization before maintenance therapy (arm IIA and IIB)
Masking
None (open label)
Enrolment
662 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03617731
Sponsor's protocol ID
GMMG HD7
Status last verified
Jan 2026
First submitted
24 Jul 2018
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 42166704

  • 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.

    PubMed 39652594

  • 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.

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  • 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.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 72 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD negativity after induction Treatment (comparison of arms IA and IB) (time frame: 18 weeks after start of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03617731, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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