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Multiple MyelomaPhase 3NCT05804032

Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma

A Phase 3 study testing Isatuximab, Lenalidomide and Bortezomib in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 91 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma. 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?
Isatuximab, Lenalidomide and Bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
514 participants
Where
91 sitesin 2 countries
Study dates
14 Apr 2023to 30 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 MM requiring systemic therapy (diagnostic criteria according to IMWG)
  • Patient is eligible for high-dose melphalan (200 mg/m^2 melphalan) and autologous stem cell transplantation
  • Measurable MM disease according to IMWG criteria, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements: serum M-protein ≥ 10 g/L; urine light-chain (M-protein) of ≥ 200 mg/24 hours; involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal
  • Age 18-70 years at trial inclusion

Who cannot join

  • Patient has known hypersensitivity (or contraindication) to any of the components of study therapy
  • Systemic amyloid light-chain amyloidosis (except for localized AL amyloidosis limited to 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 MM progression
  • Severe cardiac dysfunction (NYHA classification III-IV)
  • Patients with active or uncontrolled hepatitis B or C or detectable liver disease due to hepatitis B or C
Show all 17Show fewer
  • HIV positivity
  • Patients with active, uncontrolled infections
  • Patients with severe renal insufficiency or requiring hemodialysis
  • Patients with peripheral neuropathy or neuropathic pain, grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events)
  • Patients with a history of any 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
  • Platelet count < 75 x 10^9/L
  • Haemoglobin ≤ 8.0 g/dL, unless related to MM
  • Absolute neutrophil count (ANC) < 1.0 x 10^9/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)
  • Pregnancy and lactation
  • For further details on inclusion/exclusion criteria please refer to the study protocol.

Trial locations and contacts

91 sites in 2 countries.

91 sites in 2 countries

Germany83 sites

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

    Aachen, 52074

  • Asklepios Kliniken Hamburg GmbH

    Altona, 20099

  • Klinikum Augsburg, II. Medizinische Klinik Hämatologie/Onkologie

    Augsburg, 86156

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

    Bad Saarow, 15526

  • MedZentrum Klinikum Bayreuth GmbH

    Bayreuth, 95445

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

    Berlin, 12200

  • Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

    Berlin, 12351

  • Klinik für Hämatologie und Stammzelltransplantation, Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Vivantes Klinikum Spandau

    Berlin, 13585

  • Bielefeld Praxis, Studiengesellschaft Onkologie

    Bielefeld, 33604

  • Evangelisches Klinikum Bethel

    Bielefeld, 33611

  • Johanniter-Krankenhaus Bonn

    Bonn, 53113

  • Universitätsklinikum Bonn, Medizinische Klinik III

    Bonn, 53127

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38114

  • Klinikum Bremen-Mitte

    Bremen, 28205

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Universitätsklinikum Köln

    Cologne, 50937

  • Carl-Thiem-Klinikum Cottbus gGmbH, 2. Medizinische Klinik

    Cottbus, 03048

  • Klinikum Darmstadt, Medizinische Klinik V Hämatologie/Onkologie

    Darmstadt, 64283

  • Städtisches Klinikum Dessau

    Dessau, 06847

  • St.-Johannes-Hospital

    Dortmund, 44137

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

    Dresden, 01307

  • Helios St. Johannes Klinik Duisburg, Medizinische Klinik 2

    Duisburg, 47166

  • Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

    Düsseldorf, 40225

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

    Düsseldorf, 40479

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

    Eschweiler, 52249

  • Universitätsklinikum Essen

    Essen, 45147

  • KEM I Evang. Kliniken Essen-Mitte gGmbH, Evangelisches Krankenhaus Essen-Werden gGmbH, Klinik für Hämatologie, Onkologie und Stammzelltransplantation

    Essen, 45239

  • Malteser Krankenhaus, St. Franziskus Hospital, Hämatologie/Onkologie

    Flensburg, 24939

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main, 60389

  • Universitätsklinikum Frankfurt, Medizinische Klinik 2, Hämatologie/Onkologie

    Frankfurt am Main, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79110

  • Gießen UK

    Giessen, 35385

  • Universitätsklinikum Göttingen

    Göttingen, 37075

  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C

    Greifswald, 17475

  • Katholisches Krankenhaus Hagen gGmbH, Klinik für Hämatologie und Onkologie

    Hagen, 58097

  • Universitätsklinikum Halle

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Onkologische Schwerpunktpraxis Heidelberg

    Heidelberg, 69115

  • Universitätsklinikum Heidelberg, Medizinische Klinik V

    Heidelberg, 69120

  • SLK Kliniken Heilbronn, Medizinische Klinik III

    Heilbronn, 74078

  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin 1

    Homburg, 66421

  • Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II, Abteilung Hämatologie und internistische Onkologie

    Jena, 07740

  • Westpfalz-Klinikum

    Kaiserslautern, 67655

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

  • Klinikverbund Allgäu, Klinikum Kempten, Hämatologie / Onkologie

    Kempten, 87439

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Gemeinschaftsklinikum Mittelrhein

    Koblenz, 56073

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Lebach, 66822

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, 67063

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Medizinische Klinik und Poliklinik

    Mainz, 55131

  • Mannheimer Onkologie Praxis

    Mannheim, 68161

  • Universitätsklinikum Mannheim, III. Medizinische Klinik

    Mannheim, 68167

  • Philipps-Universität Marburg, Abteilung Hämatologie, Onkologie und Immunologie am Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35037

  • Klinikum Hochsauerland

    Meschede, 59870

  • Kliniken Maria Hilf GmbH, Medizinische Klinik I

    Mönchengladbach, 41063

  • Rotkreuzklinikum

    München, 80634

  • Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie

    München, 81675

  • Universitätsklinikum Münster, 1. Medizinische Klinik A

    Münster, 48149

  • Kliniken Ostalb - Standort Stauferklinikum, Hämatologie und Onkologie

    Mutlangen, 73557

  • Klinikum Nürnberg

    Nuremberg, 90419

  • Klinik Oldenburg

    Oldenburg, 26133

  • Klinikum Osnabrück

    Osnabrück, 49076

  • Brüderkrankenhaus St. Josef

    Paderborn, 33098

  • Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie

    Regensburg, 93049

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • CaritasKlinikum Saarbrücken St. Theresia

    Saarbrücken, 66113

  • Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III (Tumorerkrankungen, Palliativmedizin)

    Schwäbisch Hall, 74523

  • Zentrum für ambulante Hämatologie und Onkologie (ZAHO)

    Siegburg, 53721

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, 67346

  • Klinikum der Landeshauptstadt Stuttgart - Katharinenhospital

    Stuttgart, 70174

  • Diakonie-Klinikum Stuttgart

    Stuttgart, 70176

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universität Tübingen, Medizinische Universitätsklinik, Innere Medizin II: Onkologie, Hämatologie, Klinische Immunologie und Rheumatologie

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78052

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

    Wiesbaden, 65199

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283

  • University of Würzburg, Med. Klinik und Poliklinik II

    Würzburg, 97080

Other trials in Germany

Austria8 sites

  • Universitätsklinikum Krems

    Krems, 3500

  • Ordensklinikum Linz

    Linz, 4020

  • Landeskrankenhaus Feldkirch-Rankweil

    Rankweil, 6830

  • Universitätsklinikum der Paracelsus, 3. Med. Abteilung/Onkologie Ambulanz

    Salzburg, 5020

  • Universitätsklinikum St. Pölten - Lilienfeld

    Sankt Pölten, 3100

  • Phyrn-Eisenwurzen Klinikum Steyr

    Steyr, 4400

  • Klinik Ottakring

    Vienna, 1160

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

About this study

Official title: A Randomized Phase III Non-inferiority Trial Assessing Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Transplant-eligible Patients With Newly Diagnosed Multiple Myeloma.

The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.

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 Product: Isatuximab, subcutaneous administration via a wearable injector system.

Randomization: Patients are randomized in one of 2 study arms (A or B) before induction therapy. Patients randomized in arm A will receive 3 cycles of the monoclonal antibody isatuximab intravenously, combined with RVd regimen (Lenalidomide, Bortezomib, Dexamethasone). Each cycle will last for 42 days. Patients in arm B will receive 3 cycles RVd plus isatuximab subcutaneously. After induction therapy, patients will receive standard intensification (usually cyclophosphamide-based mobilization therapy, stem cell collection and high-dose melphalan followed by autologous stem cell transplantation (HDM/ASCT)). End of study will be after the first HDM/ASCT.

There is one primary objective:

Demonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous (IV) isatuximab, both in combination with RVd, with respect to rates of VGPR or better after induction therapy (according to standard International Myeloma Working Group (IMWG) response criteria).

Key secondary objectives are:

  1. Comparison of patient-reported outcomes (PRO) regarding route of administration of isatuximab (SC vs. IV) on induction therapy as assessed by modified CTSQ (modified 9-item questionnaire).
  2. Non-inferiority of rates of MRD negativity (assessed by NGS from BMA; sensitivity 10^-5) independent of standard IMWG response after induction therapy.

The duration of the trial for each patients is expected to be approximately 10 months (induction and intensification treatment).

Being tested
Isatuximab, Lenalidomide, Bortezomib, Dexamethasone
Keywords
Neoplasms, Paraproteinemias, Lymphoproliferative Disorders, Immunoproliferative Disorders, Lenalidomide, Bortezomib, Dexamethasone, Isatuximab, Monoclonal antibodies
Medical subject headings
Multiple Myeloma, Neoplasms, Paraproteinemias, Lymphoproliferative Disorders, Immunoproliferative Disorders

What participants receive

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

  • IsatuximabDrug

    Also called Sarclisa

    IV isatuximab will be administered weekly in the first cycle (Cycle 1) on days 1, 8, 15, 22, 29, and biweekly on the 2 subsequent cycles at days 1, 15 and 29, at the dose of 10 mg/kg.

  • IsatuximabDrug

    Also called Sarclisa

    SC isatuximab will be administered on days 1, 8, 15, 22, 29 of cycle 1, and on days 1, 15 and 29 of cycles 2-3, at the dose of 1400 mg

  • LenalidomideDrug

    Both arms: 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3

  • BortezomibDrug

    Also called Velcade

    Both 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, 4-5, 8-9, 11-12, 15; and 22-23, 25-26, 29-30, 32-33 in induction cycles 1-3.

Study groups in NCT05804032
Study groupRoleWhat they receive
Arm A - Intravenous isatuximabActive comparatorPatients in arm A are treated with 3 cycles RVd + i.v. isatuximab, followed by a standard intensification and autologous stem cell transplantation.
Receives: Drug: Isatuximab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone
Arm B - Subcutaneous isatuximabExperimentalPatients in arm B are treated with 3 cycles RVd + s.c. isatuximab, followed by a standard intensification and autologous stem cell transplantation.
Receives: Drug: Isatuximab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

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

  1. Demonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous (IV) isatuximab, both in combination with RVd.

    Rates of VGPR or better (according to standard IMWG response criteria), defined as proportion of patients with at least VGPR after induction therapy (according to standard International Myeloma Working Group (IMWG) response criteria).

    Measured: 18 weeks after start of study treatment

Secondary outcomes (5)

  1. Quality of life compared between Arm A and B.

    Comparison of PRO (patient-reported outcome) regarding route of administration of isatuximab (SC vs. IV) on induction therapy as assessed by modified CTSQ (modified 9-item questionnaire)

    Measured: 18 weeks after start of study treatment

  2. Non-inferiority of rates of MRD negativity in Arm B compared to Arm A

    Rates of NGS-MRD negativity (sensitivity 10^-5, from bone marrow aspirate) after induction therapy

    Measured: 18 weeks after start of study treatment

  3. Rates of MRD negativity by NGS and NGF (sensitivity 10^-5, from BMA) independent of standard IMWG response after first HDM/ASCT

    defined as proportion of negative patients with the corresponding MRD method (NGS or NGF) at the defined timepoint (after induction therapy or first HDM/ASCT)

    Measured: 18 weeks (timepoint "after induction") or 35 weeks (timepoint "after first HDM/ASCT") after start of study treatment

  4. Rates of best overall response to treatment (BOR)

    proportion of patients with BOR (at least PR or better) to treatment until end of study (based on timepoints post induction cycle 2 and 3, prior to HDM/ASCT and post first HDM/ASCT)

    Measured: Depending on the timepoint of best response out of all response assessments, up to 10 months from randomization

  5. Progression-free survival (PFS)

    Time from randomization (at study inclusion) to progression or death from any cause whichever occurs first

    Measured: Until EOS (28 months after start of study)

Timeline

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

  1. First posted7 Apr 2023
  2. Study start14 Apr 2023
  3. Primary completion30 Jan 2026
  4. Study completion30 Jan 2026

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
Masking
None (open label)
Enrolment
514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05804032
Sponsor's protocol ID
GMMG-HD8/DSMM XIX
Status last verified
Feb 2026
First submitted
21 Mar 2023
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Isatuximab, Lenalidomide and Bortezomib in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 91 sites in 2 countries.

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 4 inclusion and 17 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: finished, as of the sponsor's last update on 18 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 91 sites in Germany, Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Demonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous (IV) isatuximab, both in combination with RVd. (time frame: 18 weeks after start of study treatment). 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 NCT05804032.

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 18 Feb 2026.

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