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New treatment option for Multiple Myeloma
Official title Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT06216158
What this study is testing
What is Iberdomide?
Iberdomide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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)
You likely can't join if
- people 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...
- Patients with a history of serious allergic reaction to another immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide)", as angioedema...
- 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...
- Previous systemic anti-myeloma treatment other than administered within the GMMG-HD8 / DSMM XIX trial or other than defined in the inclusion criteria...
See the full eligibility criteria
Who can 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...
- 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
- 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)
What rules you out
- people 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- people, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Participation in other treatment clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months.
The study team makes the final eligibility decision.
Where it's taking place
- Krems, Austria
- Linz, Austria
- Salzburg, Austria
- Vienna, Austria
- Wels, Austria
- Aachen, Germany
- Augsburg, Germany
- Bad Saarow, Germany
- Berlin, Germany
- Bielefeld, Germany
- Bonn, Germany
- Braunschweig, Germany
- Chemnitz, Germany
- Cottbus, Germany
- Darmstadt, Germany
- Dessau, Germany
- Dortmund, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Eschweiler, Germany
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Krems, Austria; Linz, Austria; Salzburg, Austria; Vienna, Austria; Wels, Austria; Aachen, Germany and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.