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)
Key facts
- Where
- Budapest IX, Budapest VIII, Nyíregyháza és Szombathely, MagyarországSee the 4 sites
- Phase
- 3. fázis
Where in Magyarország
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai IntezetBudapest IX, MagyarországNo longer taking part
- Semmelweis UniversityBudapest VIII, MagyarországNo longer taking part
- Szabolcs Szatmár Bereg Vármegyei OktatókórházNyíregyháza, MagyarországNo longer taking part
- Vas Varmegyei Markusovszky Egyetemi OktatokorhazSzombathely, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celgene International II S.a.r.l.
- Trial code
- EU 2023-509472-42-00
- Record updated
- 2024. április 23.
- Original description
The main goal is to see if alnuctamab can help people live longer without their cancer getting worse, compared to standard treatments.Read full original descriptionShow less
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
The main goal is to see if alnuctamab can help people live longer without their cancer getting worse, compared to standard treatments.
Inclusion: 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.
Exclusion: 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]); 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; Participant is not eligible for any SOC regimen on the control arm.