Clinical trial · Interventional
A Study to Evaluate 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
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alnuctamab | Drug | — | UNRESOLVED |
| Carfilzomib | Drug | Carfilzomib | ALIAS |
| Daratumumab | Drug | Daratumumab | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Elotuzumab | Drug | Elotuzumab | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Alnuctamab
- interventionNames
- Drug: Alnuctamab
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Standard of Care Regimens
- interventionNames
- Drug: Pomalidomide
- Drug: Daratumumab
- Drug: Elotuzumab
- Drug: Carfilzomib
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- Up to 5 years
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle. * Documented diagnosis of multiple myeloma (MM), and must:. i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy. ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles). iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy. iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response. * Must have measurable disease (as determined by central laboratory). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening. Exclusion Criteria * Active, uncontrolled, or suspected infection. * Known current, or history of, central nervous system involvement of multiple myeloma. * History or presence of clinically relevant CNS pathology. * Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy. * Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention. * Other protocol-defined Inclusion/Exclusion criteria apply.
References
Publications (0)
Data not yet available