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

February 16, 2026 updated by: Prof. Dr. Hartmut Goldschmidt, University of Heidelberg Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
514

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Krems, Austria, 3500
        • Universitatsklinikum Krems
      • Linz, Austria, 4020
        • Ordensklinikum Linz
      • Rankweil, Austria, 6830
        • Landeskrankenhaus Feldkirch-Rankweil
      • Salzburg, Austria, 5020
        • Universitätsklinikum der Paracelsus, 3. Med. Abteilung/Onkologie Ambulanz
      • Sankt Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten - Lilienfeld
      • Steyr, Austria, 4400
        • Phyrn-Eisenwurzen Klinikum Steyr
      • Vienna, Austria, 1160
        • Klinik Ottakring
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
      • Altona, Germany, 20099
        • Asklepios Kliniken Hamburg GmbH
      • Augsburg, Germany, 86156
        • Klinikum Augsburg, II. Medizinische Klinik Hämatologie/Onkologie
      • Bad Saarow, Germany, 15526
        • Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin
      • Bayreuth, Germany, 95445
        • MedZentrum Klinikum Bayreuth GmbH
      • Berlin, Germany, 13585
        • Vivantes Klinikum Spandau
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie
      • Berlin, Germany, 12200
        • Charité, III. Medizinische Abteilung (Hämatologie/Onkologie)
      • Berlin, Germany, 13125
        • Klinik für Hämatologie und Stammzelltransplantation, Helios Klinikum Berlin-Buch
      • Bielefeld, Germany, 33611
        • Evangelisches Klinikum Bethel
      • Bielefeld, Germany, 33604
        • Bielefeld Praxis, Studiengesellschaft Onkologie
      • Bonn, Germany, 53113
        • Johanniter-Krankenhaus Bonn
      • Bonn, Germany, 53127
        • Universitätsklinikum bonn, medizinische klinik III
      • Braunschweig, Germany, 38114
        • Städtisches Klinikum Braunschweig
      • Bremen, Germany, 28205
        • Klinikum Bremen-Mitte
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz gGmbH
      • Cologne, Germany, 50937
        • Universitätsklinikum Köln
      • Cottbus, Germany, 03048
        • Carl-Thiem-Klinikum Cottbus gGmbH, 2. Medizinische Klinik
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt, Medizinische Klinik V Hämatologie/Onkologie
      • Dessau, Germany, 06847
        • Städtisches Klinikum Dessau
      • Dortmund, Germany, 44137
        • St.-Johannes-Hospital
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik I
      • Duisburg, Germany, 47166
        • Helios St. Johannes Klinik Duisburg, Medizinische Klinik 2
      • Düsseldorf, Germany, 40479
        • Marien Hospital Düsseldorf GmbH, Klinik für Onkologie, Hämatalogie und Palliativmedizin
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie
      • Eschweiler, Germany, 52249
        • St. Antonius-Hospital Eschweiler, Klinik für Hämatologie / Onkologie
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
      • Essen, Germany, 45239
        • KEM I Evang. Kliniken Essen-Mitte gGmbH, Evangelisches Krankenhaus Essen-Werden gGmbH, Klinik für Hämatologie, Onkologie und Stammzelltransplantation
      • Flensburg, Germany, 24939
        • Malteser Krankenhaus, St. Franziskus Hospital, Hämatologie/Onkologie
      • Frankfurt am Main, Germany, 60389
        • Centrum fur Hamatologie und Onkologie Bethanien
      • Frankfurt am Main, Germany, 60590
        • Universitätsklinikum Frankfurt, Medizinische Klinik 2, Hämatologie/Onkologie
      • Freiburg im Breisgau, Germany, 79110
        • Universitatsklinikum Freiburg
      • Giessen, Germany, 35385
        • Gießen UK
      • Greifswald, Germany, 17475
        • Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C
      • Göttingen, Germany, 37075
        • Universitätsklinikum Göttingen
      • Hagen, Germany, 58097
        • Katholisches Krankenhaus Hagen gGmbH, Klinik für Hämatologie und Onkologie
      • Halle, Germany, 06120
        • Universitätsklinikum Halle
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69115
        • Onkologische Schwerpunktpraxis Heidelberg
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg, Medizinische Klinik V
      • Heilbronn, Germany, 74078
        • SLK Kliniken Heilbronn, Medizinische Klinik III
      • Homburg, Germany, 66421
        • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin 1
      • Jena, Germany, 07740
        • Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II, Abteilung Hämatologie und internistische Onkologie
      • Kaiserslautern, Germany, 67655
        • Westpfalz-Klinikum
      • Karlsruhe, Germany, 76133
        • Stadtisches Klinikum Karlsruhe
      • Kempten, Germany, 87439
        • Klinikverbund Allgäu, Klinikum Kempten, Hämatologie / Onkologie
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
      • Koblenz, Germany, 56073
        • Gemeinschaftsklinikum Mittelrhein
      • Lebach, Germany, 66822
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Medizinische Klinik und Poliklinik
      • Mannheim, Germany, 68161
        • Mannheimer Onkologie Praxis
      • Mannheim, Germany, 68167
        • Universitätsklinikum Mannheim, III. Medizinische Klinik
      • Marburg, Germany, 35037
        • Philipps-Universität Marburg, Abteilung Hämatologie, Onkologie und Immunologie am Universitätsklinikum Gießen und Marburg GmbH
      • Meschede, Germany, 59870
        • Klinikum Hochsauerland
      • Mutlangen, Germany, 73557
        • Kliniken Ostalb - Standort Stauferklinikum, Hämatologie und Onkologie
      • Mönchengladbach, Germany, 41063
        • Kliniken Maria Hilf GmbH, Medizinische Klinik I
      • München, Germany, 80634
        • Rotkreuzklinikum
      • München, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie
      • Münster, Germany, 48149
        • Universitätsklinikum Münster, 1. Medizinische Klinik A
      • Nuremberg, Germany, 90419
        • Klinikum Nürnberg
      • Oldenburg, Germany, 26133
        • Klinik Oldenburg
      • Osnabrück, Germany, 49076
        • Klinikum Osnabrück
      • Paderborn, Germany, 33098
        • Brüderkrankenhaus St. Josef
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Regensburg, Germany, 93049
        • Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
      • Saarbrücken, Germany, 66113
        • Caritasklinikum Saarbrücken St. Theresia
      • Schwäbisch Hall, Germany, 74523
        • Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III (Tumorerkrankungen, Palliativmedizin)
      • Siegburg, Germany, 53721
        • Zentrum für ambulante Hämatologie und Onkologie (ZAHO)
      • Speyer, Germany, 67346
        • Onkologische Schwerpunktpraxis Speyer
      • Stuttgart, Germany, 70176
        • Diakonie-Klinikum Stuttgart
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus
      • Stuttgart, Germany, 70174
        • Klinikum der Landeshauptstadt Stuttgart - Katharinenhospital
      • Tübingen, Germany, 72076
        • Universität Tübingen, Medizinische Universitätsklinik, Innere Medizin II: Onkologie, Hämatologie, Klinische Immunologie und Rheumatologie
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
      • Villingen-Schwenningen, Germany, 78052
        • Schwarzwald-Baar Klinikum
      • Wiesbaden, Germany, 65199
        • Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
      • Wuppertal, Germany, 42283
        • Helios Universitätsklinikum Wuppertal
      • Würzburg, Germany, 97080
        • University of Würzburg, Med. Klinik und Poliklinik II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm A - Intravenous isatuximab
Patients in arm A are treated with 3 cycles RVd + i.v. isatuximab, followed by a standard intensification and autologous stem cell transplantation.
Drug: Isatuximab
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.
Other Names:
  • Sarclisa
Drug: Isatuximab
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
Other Names:
  • Sarclisa
Drug: Lenalidomide
Both arms: 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3
Drug: Bortezomib
Both arms: 1.3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles
Other Names:
  • Velcade
Drug: Dexamethasone
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.
Experimental: Arm B - Subcutaneous isatuximab
Patients in arm B are treated with 3 cycles RVd + s.c. isatuximab, followed by a standard intensification and autologous stem cell transplantation.
Drug: Isatuximab
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.
Other Names:
  • Sarclisa
Drug: Isatuximab
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
Other Names:
  • Sarclisa
Drug: Lenalidomide
Both arms: 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3
Drug: Bortezomib
Both arms: 1.3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles
Other Names:
  • Velcade
Drug: Dexamethasone
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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).
18 weeks after start of study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life compared between Arm A and B.
Time Frame: 18 weeks after start of study treatment
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)
18 weeks after start of study treatment
Non-inferiority of rates of MRD negativity in Arm B compared to Arm A
Time Frame: 18 weeks after start of study treatment
Rates of NGS-MRD negativity (sensitivity 10^-5, from bone marrow aspirate) after induction therapy
18 weeks after start of study treatment
Rates of MRD negativity by NGS and NGF (sensitivity 10^-5, from BMA) independent of standard IMWG response after first HDM/ASCT
Time Frame: 18 weeks (timepoint "after induction") or 35 weeks (timepoint "after first HDM/ASCT") after start of study treatment
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)
18 weeks (timepoint "after induction") or 35 weeks (timepoint "after first HDM/ASCT") after start of study treatment
Rates of best overall response to treatment (BOR)
Time Frame: Depending on the timepoint of best response out of all response assessments, up to 10 months from randomization
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)
Depending on the timepoint of best response out of all response assessments, up to 10 months from randomization
Progression-free survival (PFS)
Time Frame: Until EOS (28 months after start of study)
Time from randomization (at study inclusion) to progression or death from any cause whichever occurs first
Until EOS (28 months after start of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Heidelberg Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi
KKS Netzwerk
Deutsche Studiengruppe Multiples Myelom (DSMM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hartmut Goldschmidt, Prof., GMMG study group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GMMG-HD8/DSMM XIX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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