2023-509472-42-00CompletedPhase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Apr 2024
Brief summary (registry, in English)
The main goal is to see if alnuctamab can help people live longer without their cancer getting worse, compared to standard treatments.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 177 (actual)
- First submitted
- 7 Dec 2023
- Start date
- 1 Mar 2024
- Lead sponsor
- Celgene International II S.a.r.l.
- Diseases
- Multiple myeloma
- EU CT number
- 2023-509472-42-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 177
- 54 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
- Participant has never achieved at least stable disease response to prior T-cell redirection therapy (TCE or chimeric antigen receptor T cell [CAR-T])
Other illness
- Participant with known current, or history of, central nervous system involvement of multiple myeloma. Evaluation of the cerebrospinal fluid and imaging is only required if central nervous system (CNS) involvement is clinically suspected during the screening process by the investigator.
Other
- Participant is not eligible for any SOC regimen on the control arm.
Who the study is looking for
- Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent form.
- Participant has a documented diagnosis of MM, and must: -Have received at least 1 but not more than 3 prior lines of anti-myeloma therapy. Note: One line can contain a planned sequence of treatments (eg, induction, [with or without] hematopoietic stem cell transplant, [with or without] consolidation, and/or [with or without] maintenance therapy).
- Have received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).
- Have achieved minimal response or better to at least 1 prior anti-myeloma therapy.
- Have documented PD during or after their last anti-myeloma therapy or failure to achieve response.
- Participants must have measurable disease (as determined by central laboratory), including at least 1 of the criteria below: - Myeloma (M)-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis. - ≥ 200 mg/24-hour urine collection by urine protein electrophoresis. - Serum free light chain levels > 100 mg/L involved light chain and an abnormal kappa/lambda (κ/λ) ratio in participants without detectable serum or urine M-protein.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (54)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck | Innsbruck | Austria | Completed |
| SCRI CCCIT Ges.m.b.H. | Salzburg | Austria | Completed |
| Noe LGA Gesundheit Region Mitte GmbH | St. Poelten | Austria | Completed |
| Medical University of Vienna | Vienna | Austria | Completed |
| Algemeen Ziekenhuis klina | Brasschaat | Belgium | Completed |
| UZ Leuven | Leuven | Belgium | Completed |
| CHR Verviers | Verviers | Belgium | Completed |
| UCL Mont-Godinne | Yvoir | Belgium | Completed |
| Fakultni nemocnice Brno | Brno | Czechia | Completed |
| University Hospital Olomouc | Olomouc | Czechia | Completed |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia | Completed |
| Technische Universität Dresden | Dresden | Germany | Completed |
| Asklepios Kliniken Hamburg GmbH | Hamburg | Germany | Completed |
| Universitaetsklinikum Heidelberg AöR | Heidelberg | Germany | Completed |
| Universitaet Leipzig | Leipzig | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR | Tuebingen | Germany | Completed |
| Hospital Germans Trias i Pujol | Badalona | Spain | Completed |
| Hospital de Jerez de la Frontera | Jerez de la Frontera | Spain | Completed |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Completed |
| Clínica Universidad de navarra | Pamplona | Spain | Completed |
| Hospital Universitario De Salamanca | Salamanca | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Completed |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Completed |
| Hopital Saint Eloi | Montpellier Cedex 5 | France | Completed |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Completed |
| Hospices Civils de Lyon | Pierre-Bénite | France | Completed |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Completed |
| CHRU De Nancy | Vandoeuvre Les Nancy | France | Completed |
| University General Hospital Attikon | Athens | Greece | Completed |
| Alexandra Hospital | Athens | Greece | Completed |
| Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet | Budapest IX | Hungary | Completed |
| Semmelweis University | Budapest VIII | Hungary | Completed |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház | Nyíregyháza | Hungary | Completed |
| Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz | Szombathely | Hungary | Completed |
| Cork University Hospital | Cork | Ireland | Completed |
| St Vincent's University Hospital | Dublin 4 | Ireland | Completed |
| St James's Hospital | Dublin 8 | Ireland | Completed |
| University Hospital Limerick | Limerick | Ireland | Completed |
| Azienda Socio Sanitaria Territoriale Ovest Milanese | Legnano | Italy | Completed |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l | Meldola | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Completed |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | Italy | Completed |
| Helse Bergen HF | Bergen | Norway | Completed |
| Akershus University Hospital | Loerenskog | Norway | Completed |
| Oslo University Hospital HF | Oslo | Norway | Completed |
| Centro Hospitalar Universitario De Lisboa Norte E.P.E. | Lisbon | Portugal | Completed |
| Hospital da Luz, S.A | Lisbon | Portugal | Completed |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. | Lisbon | Portugal | Completed |
| Onco Card S.R.L. | Brasov | Romania | Completed |
| Institutul Clinic Fundeni | Bucharest | Romania | Completed |
| Spitalul Universitar de Urgență București | Bucharest | Romania | Completed |
| Sodra Alvsborg Hospital-Vastra Gotalandsregionen | Boras | Sweden | Completed |
| Sahlgrenska University Hospital-Vastra Gotalandsregionen | Goteborg | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.