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

NCT ID: NCT03617731

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 662 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2028-06-30

Brief 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

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).

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IA

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.

Group Type: ACTIVE_COMPARATOR

Lenalidomide

Intervention Type: DRUG

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)

Bortezomib

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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.

IB

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.

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

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)

Bortezomib

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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.

Isatuximab

Intervention Type: DRUG

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)

IIA

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.

Group Type: ACTIVE_COMPARATOR

Lenalidomide

Intervention Type: DRUG

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)

IIB

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.

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

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)

Isatuximab

Intervention Type: DRUG

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)

Interventions

Lenalidomide

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)

Intervention Type: DRUG

Bortezomib

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

Intervention Type: DRUG

Dexamethasone

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.

Intervention Type: DRUG

Isatuximab

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)

Intervention Type: DRUG

Other Intervention Names

Revlimid; Velcade

Eligibility Criteria

Inclusion Criteria

1. 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.)

2. Patient is eligible for high dose therapy and autologous stem cell transplantation.

3. 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

4. Age 18 - 70 years inclusive

5. WHO performance status 0-2

6. Negative pregnancy test at inclusion (females of childbearing potential)

7. 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.

8. 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

9. Ability of patient to understand character and individual consequences of the clinical trial

10. Provide written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

1. 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.

2. Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)

3. Plasma cell leukemia

4. 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

5. Severe cardiac dysfunction (NYHA classification III-IV), ejection fraction < 40%

6. 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.

7. Patients with active or history of hepatitis B or C

8. HIV positivity

9. Patients with active, uncontrolled infections

10. Patients with severe renal insufficiency (Creatinine Clearance < 30ml/min)

11. 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)

12. 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

13. Patients with acute diffuse infiltrative pulmonary and/or pericardial disease

14. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia

15. Platelet count < 75 x 109/l

16. Haemoglobin < 8.0 g/dl, unless related to myeloma

17. Absolute neutrophil count (ANC) < 1.0 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed)

18. Corrected serum calcium > 14 mg/dl (> 3.5 mmol/l)

19. Unable or unwilling to undergo thromboprophylaxis

20. Pregnancy and lactation

21. 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.

22. 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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Heidelberg Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Hartmut Goldschmidt

Head of Division of Multiple Myeloma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hartmut Goldschmidt, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Med. Klinik V, University Hospital Heidelberg

Locations

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

Aachen, , Germany

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

Bad Saarow, , Germany

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

Berlin, , Germany

Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

Berlin, , Germany

HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie

Berlin, , Germany

Studiengesellschaft Onkologie Bielefeld GbR

Bielefeld, , Germany

Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin

Bielefeld, , Germany

Medizinische Universitätsklinik, Knappschaftskrankenhaus

Bochum, , Germany

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

Bonn, , Germany

Johanniter Krankenhaus Bonn

Bonn, , Germany

Zentrum für ambulante Hämatologie und Onkologie (ZAHO)

Bonn, , Germany

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

Braunschweig, , Germany

Klinikum Chemnitz GmbH, Innere Medizin III

Chemnitz, , Germany

Uniklinik Köln, Klinik I für Innere Medizin

Cologne, , Germany

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

Cottbus, , Germany

Onkologisches Studienzentrum Darmstadt

Darmstadt, , Germany

Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie

Darmstadt, , Germany

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

Dresden, , Germany

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

Duisburg, , Germany

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

Düsseldorf, , Germany

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

Düsseldorf, , Germany

Universitätsklinik Erlangen

Erlangen, , Germany

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

Eschweiler, , Germany

Universitätsklinikum Essen, Klinik für Hämatologie

Essen, , Germany

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

Essen, , Germany

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

Frankfurt (Oder), , Germany

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), , Germany

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, , Germany

Agaplesion Markus Krankenhaus, Med. Klinik I

Frankfurt am Main, , Germany

Krankenhaus Nordwest, Institut für Klinisch-Onkologische Forschung

Frankfurt am Main, , Germany

Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II

Frankfurt am Main, , Germany

Klinikum Fulda, Klinisches Studienzentrum GmbH

Fulda, , Germany

Universitätsklinik der Justus-Liebig-Universität, Medizinische Klinik IV

Giessen, , Germany

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

Goch, , Germany

Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie

Hagen, , Germany

Asklepios Klinik Hamburg St. Georg

Hamburg, , Germany

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

Hamburg, , Germany

Asklepios Klinik Hamburg Altona, II. Med. Klinik

Hamburg, , Germany

Immunologisch-onkologisches MVZ am Siloah Krankenhaus

Hanover, , Germany

KRH Klinikum Siloah, Klinik für Hämatologie und Onkologie

Hanover, , Germany

Onkologische Schwerpunktpraxis Heidelberg

Heidelberg, , Germany

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

Heidelberg, , Germany

University Hospital Heidelberg, Med. Klinik V

Heidelberg, , Germany

SLK Kliniken Heilbronn, Med. Klinik III

Heilbronn, , Germany

Marien Hospital Herne

Herne, , Germany

Universitätsklinikum des Saarlandes, Innere Medizin I

Homburg (Saar), , Germany

Westpfalz-Klinikum GmbH, Klinik für Innere Medizin I

Kaiserslautern, , Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Praxisklinik für Hämatologie und Onkologie

Koblenz, , Germany

Gemeinschaftspraxis für Hämatologie und Onkologie am Caritas Krankenhaus

Lebach, , Germany

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

Leipzig, , Germany

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

Ludwigshafen am Rhein, , Germany

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

Mainz, , Germany

III. Medizinische Klinik Hämatologie und Internistische Onkologie

Mannheim, , Germany

Mannheimer Onkologie Praxis

Mannheim, , Germany

Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie

Marburg, , Germany

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

Minden, , Germany

Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I

Mönchengladbach, , Germany

Universitätsklinikum Münster, Med. Klinik A

Münster, , Germany

Klinikum Osnabrück GmbH

Osnabrück, , Germany

Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie

Paderborn, , Germany

Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie

Regensburg, , Germany

Gemeinschaftspraxis für Hämatologie und Onkologie, Onkologisches Zentrum

Saarlouis, , Germany

Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III

Schwäbisch Hall, , Germany

ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg

Siegburg, , Germany

Onkologische Schwerpunktpraxis Speyer

Speyer, , Germany

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

Stuttgart, , Germany

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, , Germany

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

Tübingen, , Germany

Bundeswehrkrankenhaus Ulm, Abteilung Innere Medizin - Hämatologie und internistische Onkologie

Ulm, , Germany

Schwarzwald-Baar Klinikum, Innere Medizin II

Villingen-Schwenningen, , Germany

Rems-Murr-Kliniken gGmbH

Winnenden, , Germany

Countries

Germany

References

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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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Other Identifiers

GMMG HD7

Identifier Type: -

Identifier Source: org_study_id