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Multiple MyelomaPhase 3NCT06216158

Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma

A Phase 3 study testing Iberdomide, Isatuximab and Dexamethasone in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 69 sites in 2 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

The goal of this clinical trial is to compare a maintenance therapy consisting of iberdomide and isatuximab with an iberdomide-only regimen. The trial is the subsequent maintenance therapy to GMMG-HD8/DSMM XIX trial for patients with newly-diagnosed multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Iberdomide, Isatuximab and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
411 participants
Where
69 sitesin 2 countries
Study dates
5 Apr 2024to Jun 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior inclusion and treatment within the GMMG-HD8 / DSMM XIX trial OR
  • Received a quadruplet induction/consolidation therapy that consists of a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) [e.g., bortezomib, thalidomide and dexamethasone, or bortezomib, lenalidomide and dexamethasone] with an anti-CD38 monoclonal antibody (isatuximab or daratumumab)
  • Post HDM/ASCT consolidation containing similar substances as induction therapy is permitted
  • Induction and consolidation therapy should make up a total of at least 4 up to 6 cycles, with a maximum of 2 consolidation cycles post HDM/ASCT AND
  • Received at least one cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT)
  • At least Partial Response (PR) according to IMWG criteria at inclusion in the trial
Show all 12Show fewer
  • Age of at least 18 years at trial inclusion
  • WHO performance status of 0, 1, or 2
  • Negative pregnancy test at inclusion (women of childbearing potential)
  • For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy
  • Ability of patient to understand character and individual consequences of the clinical trial
  • Written informed consent (must be available before enrolment in the trial)

Who cannot join

  • Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide
  • Patient has known hypersensitivity (or contraindication) to any of the components of study therapy that are not amenable to premedication with steroids or H1 blockers and that would prohibit further treatment with these agents (e.g. known intolerance or hypersensitivity to infused proteins products, sucrose, histidine, and polysorbate 80 as well as intolerance to arginine and Poloxamer 188)
  • Patients with a history of serious allergic reaction to another immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide)", as angioedema and severe dermatologic reactions, including Grade 4 rash and exfoliative or bullous rash
  • Patients currently being treated with strong inhibitors or inducers of CYP3A4/5
  • Systemic AL amyloidosis (except for localized AL amyloidosis limited to the skin or the bone marrow), plasma cell leukemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein and skin abnormalities or Waldenström macroglobulinemia.
  • Previous systemic anti-myeloma treatment other than administered within the GMMG-HD8 / DSMM XIX trial or other than defined in the inclusion criteria above (including up to two cycles cycle high dose melphalan therapy (HDM) and autologous stem cell transplantation (ASCT). Local, consolidative radiotherapy for myeloma disease is permitted unless performed in case of progressive disease according to IMWG criteria
Show all 25Show fewer
  • Severe cardiac dysfunction (NYHA classification III-IV)
  • 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 MM or HDM/ASCT.
  • Patients with active or uncontrolled hepatitis B or C or detectable liver disease due to hepatitis B or C. In case of history of hepatitis B or C, it must be clarified whether it has been overcome and negative circulating HBV-DNA or HCV-RNA must be provided. Positive hepatitis B status may only be acceptable in absence of circulating HBV-DNA or signs of chronic or acute infection and if an adequate prophylaxis is being implemented during the course of the study. Prophylaxis for patients with history of hepatitis B or C should be set on a patient individual basis.
  • HIV positivity
  • Patients with active, uncontrolled infections
  • Patients with severe renal insufficiency (Creatinine Clearance < 30ml/min) 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 (NCI CTCAE, version 5.0)
  • 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. A history of an early stage malignancy during the past 5 years may be acceptable, however, in this case the GMMG study office has to be consulted prior to study inclusion
  • Patients with acute diffuse infiltrative pulmonary and/or pericardial disease
  • Autoimmune haemolytic anaemia with positive indirect Coombs test or immune thrombocytopenia
  • Platelet count < 75 x 109/l
  • Haemoglobin ≤ 8.0 g/dl, unless related to MM
  • 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
  • Participant has any concurrent severe and/or uncontrolled medical condition or psychiatric disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study or that confounds the ability to interpret data from the study
  • Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
  • Participation in other interventional clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months.

Trial locations and contacts

69 sites in 2 countries.

69 sites in 2 countries

Germany64 sites

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

    Aachen, 52074

  • Universitätsklinikum

    Augsburg, 86156

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

  • Charité, III. Medizinische Abteilung

    Berlin, 12200

  • Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

    Berlin, 12351

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604

  • Evangelisches Klinikum Bethel

    Bielefeld, 33611

  • Johanniter Krankenhaus

    Bonn, 53113

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Städtisches Klinikum

    Braunschweig, 38114

  • Klinikum Chemnitz

    Chemnitz, 09116

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

    Cottbus, 03048

  • Klinikum Darmstadt GmbH, Medizinische Klinik V

    Darmstadt, 64283

  • Städtisches Klinikum

    Dessau, 06847

  • St. Johannes Hospital Dortmund

    Dortmund, 44137

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

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

    Düsseldorf, 40479

  • St. Antonius-Hospital

    Eschweiler, 52249

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

    Essen, 45239

  • Malteser Krankenhaus

    Flensburg, 24939

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main, 60389

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Katholisches Krankenhaus Hagen

    Hagen, 58097

  • Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie

    Hamburg, 20246

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Onkologische Schwerpunktpraxis

    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

  • Klinikverbund Allgäu, Klinikum Kempten, Hämatologie / Onkologie

    Kempten, 87439

  • Gemeinschaftsklinikum Mittelrhein Koblenz

    Koblenz, 56073

  • Oncocare, Gemeinschaftspraxis für Hämatologie und Onkologie

    Lebach, 66822

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, 67063

  • Universitätsmedizin der Johannes Gutenberg-Universität

    Mainz, 55131

  • Universitätsklinikum Mannheim, III. Medizinische Klinik

    Mannheim, 68167

  • Onkologie Praxis

    Mannheim, 69161

  • Philipps-Universität Marburg Hämatologie/Onkologie

    Marburg, 35043

  • Klinikum Hochsauerland

    Meschede, 59870

  • Kliniken Maria Hilf

    Mönchengladbach, 41063

  • Rotkreuzklinikum

    München, 80634

  • Klinikum rechts der Isar der TU München

    München, 81675

  • Kliniken Ostalb

    Mutlangen, 73557

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Klinikum Osnabrück GmbH

    Osnabrück, 49076

  • Brüderkrankenhaus St. Josef

    Paderborn, 33098

  • Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie

    Regensburg, 93049

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Diakoneo Diak Klinikum

    Schwäbisch Hall, 74523

  • ZAHO - Zentrum für ambulante Hämatologie und Onkologie

    Siegburg, 53721

  • Onkologische Schwerpunktpraxis Speyer

    Speyer, 67346

  • Klinikum der Landeshauptstadt Stuttgart - Katharinenhospital

    Stuttgart, 70174

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum

    Ulm, 89081

  • Schwarzwald Baar Klinikum

    Villingen-Schwenningen, 78052

  • University of Würzburg, Med. Klinik und Poliklinik II

    Würzburg, 97080

Other trials in Germany

Austria5 sites

  • Universitätsklinikum Krems an der Donau

    Krems, 3500

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020

  • Landeskrankenhaus Salzburg, Universitätsklinik für Innere Medizin III

    Salzburg, 5020

  • Klinik Ottakring Wien

    Vienna, 1160

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

About this study

Official title: A Randomized Phase III Trial Assessing Iberdomide Versus Iberdomide Plus Isatuximab Maintenance Therapy Post Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

The goal of this clinical trial is to compare a maintenance therapy consisting of iberdomide and isatuximab with an iberdomide-only regimen. The trial is the subsequent maintenance therapy to GMMG-HD8/DSMM XIX trial for patients with newly-diagnosed multiple myeloma. Patients with newly-diagnosed multiple myeloma who underwent a similar quadruplet induction/consolidation therapy regimen followed by at least one ASCT can also be recruited. The main question it aims to answer is:

  • Will the addition of isatuximab lead to decreased amounts of measurable myeloma cells in the bone marrow after two years?
Read the detailed description

Prospective, multicentre, randomised, parallel group, open, phase III clinical trial for a maintenance therapy, for patients who underwent an induction therapy and autologous stem cell transplantation (ASCT) in the GMMG-HD8/DSMM XIX trial or a similar quadruplet induction/consolidation therapy regimen followed by at least one ASCT.

Investigational Medicinal Product: Iberdomid (oral), isatuximab (subcutaneous administration via a wearable injector system).

Randomisation will be performed centrally by GMMG/DSMM offices after verification of the eligibility of the patient. At the time of study inclusion, randomization will be performed into arm A (iberdomide) or arm B (iberdomide + isatuximab). Randomization will be stratified by centrally assessed MRD negativity status (yes vs. no vs. unknown); assessed by NGF from BMA; sensitivity of 10^-5; independent of standard IMWG response) and number of HDM/ASCT (single vs. tandem).

Patients randomized in arm A will receive 39 cycles of the drug iberdomide, a Cereblon E3 Ubiquitin Ligase Modulating Drug (CELMoD®) that shares structural similarities to the immunomodulatory compounds (IMiDs) such as thalidomide and lenalidomide. Each cycle will last for 29 days. Patients in arm B will receive the same the 39 cycles of iberdomide plus monoclonal anti-CD38 antibody isatuximab subcutaneously. In both arms, patients will receive 20 mg dexamethasone in cycle 1, on the same days as the isatuximab administration in Arm B. End of study will be after 36 months of the maintenance therapy.

There is one primary objective:

  • Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease (MRD) negativity rates (sensitivity 2x10^-6 via next-generation flow cytometry [NGF]) after two years of maintenance therapy.

There is one key secondary objective:

  • PFS, defined as time from randomization to disease progression or death from any cause, whichever occurs first.

Further secondary objectives are:

  • Rates of sustained MRD negativity (at sensitivity levels of 10-5 and 2x10^-6 via NGF from BMA) after 1, 2 and 3 years of maintenance therapy.
  • Conversion from MRD positive to negative (at sensitivity levels of 10^-5 and 2x10^-6 via NGF from BMA).
  • Rates of best overall response to treatment (BOR).
  • Rates of partial response (PR), very good partial response (VGPR), complete response (CR) and stringent complete response (sCR).
  • Time-to-next-treatment (TTNT).
  • PFS on subsequent line of therapy.
  • Overall survival (OS).
  • Improvement of IMWG response categories (PR, VGPR, CR, sCR).
  • Proportions of patients in both treatment arms maintaining BOR and CR from baseline.
  • Assessment of quality-of-life (QoL) via the EORTC-QLQC30, EORTC-QLQMY20, and EQ-5D-5L questionnaires.
Being tested
Iberdomide, Isatuximab, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

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

  • IberdomideDrug

    Iberdomide p.o. (0.75 mg, day 1-21 of each 29-days cycle)

  • IsatuximabDrug

    Also called Sarclisa

    Isatuximab s.c. (1400 mg, cycle 1: day 1, 8, 15, 22; cycles 2-3: day 1 and 15; from C4: day 1)

  • DexamethasoneDrug

    Dexamethasone p.o. or i.v. (20 mg, cycle 1 only: day 1, 8, 15, 22)

Study groups in NCT06216158
Study groupRoleWhat they receive
Arm A: IberdomideActive comparator36 months of oral iberdomide administration; In cycle 1, dexamethasone is added as pre-medication
Receives: Drug: Iberdomide; Drug: Dexamethasone
Arm B: Iberdomide plus isatuximabExperimental36 months of oral iberdomide plus subcutaneous isatuximab administration; In cycle 1, dexamethasone is added as pre-medication
Receives: Drug: Iberdomide; Drug: Isatuximab; Drug: Dexamethasone

What is being measured

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

  1. Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease (MRD).

    The primary objective of this trial is to compare the two-year MRD negativity rate (sensitivity 2x10^-6 via next-generation flow cytometry [NGF]; from bone marrow aspirate) when treated with iberdomide plus isatuximab, with the MRD negativity after treatment with iberdomide only.

    Measured: 24 months after start of maintenance therapy

Secondary outcomes (1)

  1. Progression-free survival (PFS) from date of randomization.

    PFS, defined as time from randomization to disease progression or death from any cause, whichever occurs first.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Timeline

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

  1. First posted22 Jan 2024
  2. Study start5 Apr 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionJun 2029 (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
Masking
None (open label)
Enrolment
411 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06216158
Sponsor's protocol ID
GMMG-HD9/DSMM XVIII
Status last verified
Aug 2026
First submitted
9 Jan 2024
Last updated
17 Aug 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 Iberdomide, Isatuximab and Dexamethasone in people with Multiple Myeloma, run by University of Heidelberg Medical Center at 69 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 12 inclusion and 25 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 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?

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?

Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease (MRD). (time frame: 24 months after start of maintenance therapy). 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 NCT06216158.

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 17 Aug 2026.

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