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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

Next steps

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.
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (54)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet InnsbruckInnsbruckAustriaCompleted
SCRI CCCIT Ges.m.b.H.SalzburgAustriaCompleted
Noe LGA Gesundheit Region Mitte GmbHSt. PoeltenAustriaCompleted
Medical University of ViennaViennaAustriaCompleted
Algemeen Ziekenhuis klinaBrasschaatBelgiumCompleted
UZ LeuvenLeuvenBelgiumCompleted
CHR VerviersVerviersBelgiumCompleted
UCL Mont-GodinneYvoirBelgiumCompleted
Fakultni nemocnice BrnoBrnoCzechiaCompleted
University Hospital OlomoucOlomoucCzechiaCompleted
Vseobecna fakultni nemocnice v PrazePragueCzechiaCompleted
Technische Universität DresdenDresdenGermanyCompleted
Asklepios Kliniken Hamburg GmbHHamburgGermanyCompleted
Universitaetsklinikum Heidelberg AöRHeidelbergGermanyCompleted
Universitaet LeipzigLeipzigGermanyCompleted
Universitaetsklinikum Tuebingen AöRTuebingenGermanyCompleted
Hospital Germans Trias i PujolBadalonaSpainCompleted
Hospital de Jerez de la FronteraJerez de la FronteraSpainCompleted
University Clinical Hospital Virgen De La ArrixacaMurciaSpainCompleted
Clínica Universidad de navarraPamplonaSpainCompleted
Hospital Universitario De SalamancaSalamancaSpainCompleted
Complexo Hospitalario Universitario De SantiagoSantiago de CompostelaSpainCompleted
Hospital Universitario Y Politecnico La FeValenciaSpainCompleted
Centre Hospitalier Universitaire De LilleLille CedexFranceCompleted
Hopital Saint EloiMontpellier Cedex 5FranceCompleted
Centre Hospitalier Universitaire de NantesNantesFranceCompleted
Hospices Civils de LyonPierre-BéniteFranceCompleted
Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9FranceCompleted
CHRU De NancyVandoeuvre Les NancyFranceCompleted
University General Hospital AttikonAthensGreeceCompleted
Alexandra HospitalAthensGreeceCompleted
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai IntezetBudapest IXHungaryCompleted
Semmelweis UniversityBudapest VIIIHungaryCompleted
Szabolcs Szatmár Bereg Vármegyei OktatókórházNyíregyházaHungaryCompleted
Vas Varmegyei Markusovszky Egyetemi OktatokorhazSzombathelyHungaryCompleted
Cork University HospitalCorkIrelandCompleted
St Vincent's University HospitalDublin 4IrelandCompleted
St James's HospitalDublin 8IrelandCompleted
University Hospital LimerickLimerickIrelandCompleted
Azienda Socio Sanitaria Territoriale Ovest MilaneseLegnanoItalyCompleted
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldolaItalyCompleted
ASST Grande Ospedale Metropolitano NiguardaMilanItalyCompleted
Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermoItalyCompleted
Helse Bergen HFBergenNorwayCompleted
Akershus University HospitalLoerenskogNorwayCompleted
Oslo University Hospital HFOsloNorwayCompleted
Centro Hospitalar Universitario De Lisboa Norte E.P.E.LisbonPortugalCompleted
Hospital da Luz, S.ALisbonPortugalCompleted
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.LisbonPortugalCompleted
Onco Card S.R.L.BrasovRomaniaCompleted
Institutul Clinic FundeniBucharestRomaniaCompleted
Spitalul Universitar de Urgență BucureștiBucharestRomaniaCompleted
Sodra Alvsborg Hospital-Vastra GotalandsregionenBorasSwedenCompleted
Sahlgrenska University Hospital-Vastra GotalandsregionenGoteborgSwedenCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.