NCT06216158 Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
| NCT ID | NCT06216158 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Heidelberg Medical Center |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 411 participants |
| Start Date | 2024-04-05 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 411 participants in total. It began in 2024-04-05 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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?
Eligibility Criteria
Inclusion Criteria: * 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 * 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) Exclusion Criteria: * 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 * 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.
Contact & Investigator
Hartmut Goldschmidt, Prof.
PRINCIPAL INVESTIGATOR
University Hospital Heidelberg
Frequently Asked Questions
Who can join the NCT06216158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06216158 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 411 participants.
Is NCT06216158 currently recruiting?
Yes, NCT06216158 is actively recruiting participants. Contact the research team at s.gmmg@med.uni-heidelberg.de for enrollment information.
Where is the NCT06216158 trial being conducted?
This trial is being conducted at Krems, Austria, Linz, Austria, Salzburg, Austria, Vienna, Austria and 11 additional locations.
Who is sponsoring the NCT06216158 clinical trial?
NCT06216158 is sponsored by University of Heidelberg Medical Center. The principal investigator is Hartmut Goldschmidt, Prof. at University Hospital Heidelberg. The trial plans to enroll 411 participants.