Multiple Myeloma
Conditions
Keywords
Relapsed or Refractory Multiple Myeloma, BMS-986349, CC-93269, RRMM, Alnuctamab, CA058-1019, ALUMMINATE RRMM
Brief summary
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).
Interventions
DRUGAlnuctamab
Specified dose on specified days
DRUGPomalidomide
Specified dose on specified days
DRUGDaratumumab
Specified dose on specified days
DRUGElotuzumab
Specified dose on specified days
DRUGCarfilzomib
Specified dose on specified days
DRUGDexamethasone
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to response (TTR) | Up to 5 years |
| Overall Survival (OS) | Up to 5 years |
| Overall response (OR) | Up to 5 years |
| Complete response (CR) or better | Up to 5 years |
| Duration of response (DOR) | Up to 5 years |
| Time to progression (TTP) | Up to 5 years |
| Time to next treatment (TTNT) | Up to 5 years |
| Very good partial response (VGPR) or better | Up to 5 years |
| Restricted mean DOR (RMDOR) | Up to 5 years |
| Minimal residual disease (MRD) negativity rate | Up to 5 years |
| Incidence of adverse events (AEs) | Up to 5 years |
| Incidence of serious adverse events (SAEs) | Up to 5 years |
| Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30) | Up to 5 years |
| Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20) | Up to 5 years |
| Progression-free survival 2 (PFS2) | Up to 5 years |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Norway, Portugal, Romania, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed